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LineaRx and Takis/Evvivax Anti-Cancer Vaccine Candidates Demonstrate Tumor Reduction 

Tumor Reduction Demonstrated In Vivo Using Two Linear DNA Vaccines in Animal Models

STONY BROOK, NY. September 19, 2019 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA”), a leader in large-scale PCR-based DNA manufacturing, announced today that LineaRx, Inc. (“LineaRx”), its majority-owned subsidiary focused on next-generation biotherapeutics, and its collaborators Takis/Evvivax have completed pre-clinical animal studies of two vaccine candidates produced with linear DNA. Tests of both vaccines in mouse models demonstrated their ability to eliminate tumors in vivo, and to potentially prevent initial occurrence.

 

Evvivax S.R.L. designed a synthetic gene sequence to produce immunity in companion animals, directed against the protein telomerase (TERT), which is overexpressed in 85% of all mammalian cancers, whereas Takis S.R.L. designed a neoantigen-based cancer vaccine (TK), as a proof-of-concept of personalized immunology. For the studies, the TERT and TK based vaccines were produced in linear DNA form by LineaRx. Here is a summary of the recently completed studies performed in vivo:

  • Previous results from Phase 1 of the collaboration’s Joint Development Agreement (JDA) confirmed immunogenicity in mice that were vaccinated with linear DNA against the human protein telomerase. The results reported herein are from the Phase 2 of the JDA using mice implanted with murine colon cancer.

  • In the prophylactic use of the telomerase vaccine, wherein vaccination is done before addition of tumor cell lines to the mice, transplanted tumors were cleared within 10 days.

  • In the therapeutic application using either TERT or TK linear DNA vaccine application, cancer cells were introduced and allowed to grow before administration of the vaccine. The successful reduction of total tumor mass was accomplished in conjunction with antibodies that targeted PD-1 and CTLA4.  These antibodies, known as Checkpoint Inhibitors, are commonly used in oncology strategies that rely upon immunotherapy. In this setting the tumor cells were reduced significantly within 30 days.

  • The strategy of the Takis TK neoantigen vaccine uses unique multiple-target antigenic epitopes that have been identified from the tumor of a human patient.  The linear DNA can utilize the genes for several of the most effective universal antigens such as TERT, or neoantigens that are more personalized to the patient.

 

“We know that immune system has a key role in fighting cancer” said Dr. Luigi Aurisicchio, CEO of Takis/Evvivax. “Thanks to a deep knowledge of Cancer Immunobiology and cutting-edge vaccination technologies we have now the tools to provide new therapies to our pet friends and human patients.”

 

“Our unique triumvirate of JDA partners is compelling, in that clinical data accumulated from linear DNA vaccines for companion animals can be used to accelerate translation to human therapies by Evvivax and Takis” said Dr. James Hayward, president and CEO of Applied DNA and LineaRx. “Cancer vaccines would extend the lives of many family pets, and the benefit we believe would rapidly enure to humans.”

 

Linear DNA vaccines are being spearheaded by LineaRx to drive more efficient production methods and what are believed to be safer therapies for patients. Current production standards for human DNA vaccines use the circular DNA of plasmids that are grown in bacteria.  However, this raises concerns regarding the risk of integration of bacterial genes including the antibiotic-resistance genes into the human genome or transfer into commensal bacteria, that are a normal part of the human bacterial flora.

 

Dr. Aurisicchio concluded, “The advantages of linear DNA should improve the safety and efficacy of all gene therapies, both in animals as well as humans.” The JDA partners expect to publish their results in the scientific literature soon and will initiate planned Phase 3 work in companion animals.

 

About LineaRx

LineaRx seeks to commercialize the biotherapeutic value of Applied DNA’s deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria. Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture. Go to www.adnas.com for more information on LineaRx and to learn more about how Applied DNA makes life real and safe. LineaRx is a majority-owned Applied DNA Sciences, Inc. (Nasdaq: APDN) company.

 

About Applied DNA Sciences

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.

 

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

 

Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

 

Forward-Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to the risk that the acquisition will not be successfully integrated with LineaRx or that the potential benefits of the acquisition will not be realized, the Company’s  history of net losses, limited financial resources, limited market acceptance , the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, ability to maintain its NASDAQ listing in light of delisting notices received  and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 18, 2018, as amended, and our subsequent quarterly reports on Form 10-Q filed on February 7, 2019,May 9, 2019 and August 13, 2019, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

 

About Evvivax S.R.L. and Takis S.R.L
EVVIVAX, whose name is derived from Engineered Veterinary Vectored Immunotherapy and Vaccines, is a spin-off of Takis Biotech. EVVIVAX pursues the discovery and development of innovative Therapeutic Veterinary Cancer Vaccines based on viral vectors and DNA platform technologies. EVVIVAX frontline candidates are two therapeutic cancer vaccines for canine tumors: Tel-eVax and Erb-eVax. EVVIVAX aims at translating scientific breakthrough achievements in Cancer Immunotherapy into marketed innovative products in Veterinary and subsequently in Human Oncology.

Visit www.evvivax.com for more information.

 

Takis is a Biotech Company created by a group of scientists from Merck Research Laboratories (MRL). The group has more than 15 years of experience and an established track record in drug discovery in Oncology and is recognized for the conception and implementation of a number of innovative technologies. One of the main assets of Takis is the expertise in in vivo electro-gene-transfer, which can be used for a variety of clinically useful applications, from vaccine development to somatic gene therapy. Takis pipeline include four Cancer Vaccine candidates based on this technology. Takis is also actively involved in the generation of humanized monoclonal antibodies for use in Oncology and Infectious Diseases.

 

Visit www.takisbiotech.it for more information.

 

investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
Program contact: Brian Viscount, 631-240-8877, brian.viscount@adnas.com

web: www.adnas.com, www.linearxdna.com

twitter: @APDN, @LineaRxDNA

Medicare Coverage of CAR T-Cell Therapy Holds Positive Implications for LineaRx

LineaRx Positioned to Benefit from Increasing Demand for Nucleic-Acid Dependent Therapies; Potential to Make Redirected Cell Therapies, such as CAR T, Faster, Safer, More Effective and with Lower Design and Manufacturing Costs

STONY BROOK, NY. August 12, 2019 – LineaRx, Inc. (“LineaRx”), a majority-owned subsidiary of Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) announced that, in a decisionrendered on August 7, 2019, the Centers for Medicare and Medicaid Services (CMS) approved chimeric antigen receptor (CAR) T-cell therapies that fit the CMS criteria for Medicare beneficiaries nationwide. LineaRx believes its unique method of manufacturing DNA is well poised to benefit from the increasing demand for nucleic-acid dependent therapies, like CAR T, as biotechnology companies pursue their gene and cell therapies with reimbursement assured by the CMS decision.

CAR T-based treatments involve extracting and genetically altering a patient’s T cells to attack a protein on the surface of cancer cells. The cells are then infused back into the patient. All approved CAR T and other redirected cell therapies are manufactured using DNA that is bacterially derived and then delivered to the patient’s T cells by a virus. Such plasmids-based treatments require about three weeks to grow and are acknowledged to have the potential for unintended side-effects. LineaRx offers a cleaner, potentially higher-performing alternative to plasmid DNAs with linear DNAs produced by PCR (Polymerase Chain Reaction) that are used to reprogram CAR T cells. Applications for redirected cells are broadly anticipated with more than 850 trials globally listed on clinicaltrials.gov.

“The oncology community has greeted CAR T cell therapy with extraordinary enthusiasm, but the use of these novel therapies to combat cancer has been constrained by pricing and reimbursement. With the CMS decision, redirected cell therapies are now a permanent part of the toolbox of modern medicine, and with LineaRx, we believe we have a more desirable manufacturing process than plasmids, that will enable biotech companies to accelerate their commercialization efforts,” stated Dr. James Hayward, president and CEO of LineaRx. “With the LineaRx ability to provide massive ultrapure DNA with shorter lead times than plasmids, its manufacturing technology should enable gene therapy companies to shorten time-to-market for their therapies and in a much more cost-efficient manner. Patients will also benefit by a more rapid turnaround. Moreover, we believe that our recent acquisition of Vitatex, which just closed last week, facilitates our development of redirected cell therapies by enabling us to study the lymphocytes that we capture alongside the circulating tumor cells from the blood of cancer patients. We believe these studies will guide us toward optimal design of the engager that allows CAR T cells to recognize their host’s cancer at a molecular level.”

Full text of CMS decision: Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N)

About LineaRx
LineaRx seeks to commercialize the biotherapeutic value of Applied DNA’s deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria. Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture. Go to www.adnas.com for more information on LineaRx and to learn more about how Applied DNA makes life real and safe. LineaRx is a majority-owned Applied DNA Sciences, Inc. (Nasdaq: APDN) company.

About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

 

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

Forward-Looking Statements
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to the risk that the acquisition will not be successfully integrated with LineaRx or that the potential benefits of the acquisition will not be realized, the Company’s  history of net losses, limited financial resources, limited market acceptance , the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, ability to maintain its NASDAQ listing in light of delisting notices received  and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 18, 2018, as amended, and our subsequent quarterly reports on Form 10-Q filed on February 7, 2019 and May 9, 2019, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

 

investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
Program contact: Brian Viscount, 631-240-8877, brian.viscount@adnas.com
web: www.adnas.com
twitter: @APDN, @LineaRxDNA

LineaRx Acquires Assets and Intellectual Property of Vitatex

Platform for Functional Isolation of Invasive Circulating Tumor Cells Empowers Three LineaRx Product Categories: Diagnostics, Prognostics and Therapeutics; Creates Integrated Product and Service Offering

STONY BROOK, NY. August 8, 2017 – LineaRx, Inc. (“LineaRx”), a wholly-owned subsidiary of Applied DNA Sciences, Inc. (“Applied DNA or the Company,” NASDAQ: APDN), announced today that it has acquired the physical assets and Intellectual Property (IP) of Vitatex Inc. (“Vitatex”), a private biotechnology company focused on advancing personalized medicine with an innovative solution that  isolates Invasive Circulating Tumor Cells (iCTCs) from standard patient blood samples. Vitatex’s solution identifies metastatic cells often before primary tumors are visible to other diagnostic technologies, when preventive care for impending cancer is still an option.

“We are honored to now include Vitatex executives on our team and employ its powerful technology within our platform,” said Dr. James Hayward, president and CEO of LineaRx. “We believe that the sophisticated technology sets us apart and integrates closely with the LineaRx service and technology offerings, broadening our addressable markets and shortening our development cycle.”

Invasive Circulating Tumor Cells (iCTCs) are isolated from the blood using Vitatex’s patented, novel functional assay that requires the cells to duplicate the metastatic behaviors of intravasation (leaving a primary tumor and initiating escape through a capillary or lymphatic vessel) and extravasation (exiting capillaries and lymphatic vessels and entering organs to form aggressive secondary tumors.) These assays are highly personalized and offer information regarding the metastatic potential of each individual’s unique cancer. The worldwide market for CTC technologies is projected to reach $17.6 billion by 2025 at a 20% CAGR over the period[1].

In contrast to competitive technologies that only recognize parts of cancer DNA, the Vitatex platform captures living cancer cells that enter the blood stream at very low rates. As such, they can be cultured and challenged against panels of cancer therapies to optimize selection of treatment tailored to each patient. Genomic information gathered from the iCTCs and associated lymphocytes that have already recognized the iCTCs as cancer can be used to target individualized cancer antigens (neoantigens) in immune therapies such as CAR T.

“We are thrilled to be joining LineaRx, whose technologies we believe will alter the future of cancer therapy. Our combined platforms offer opportunities to diagnose cancer early, personalize redirected cell therapies, and predict outcomes across many cancer indications,” stated Dr. Wen-Tien Chen, Research Professor of Medical Oncology at Stony Brook University, and the founder and president of Vitatex.

Dr. Chen, who joins LineaRx as a Consulting Emeritus Scientist and Principal Investigator, discovered the enzyme seprase while serving as Director of the Tumor Invasion and Metastasis Program at Georgetown University. Seprase is a protease (a protein-digesting enzyme) secreted at the invasive front of metastasizing cancers.  Included in the IP acquired by LineaRx, are several hybridoma cell lines, including one that produces antibodies directed against seprase. These antibodies have potential both as therapeutics as well as for characterizing iCTCs as cancerous.

Dr. Michael Pearl, Professor of Gynecological Oncology and Medical Director of the Cancer Center Clinical Trials Office at Stony Brook University Hospital, and author of multiple papers on iCTCs, stated: “Although the prevalence of ovarian cancer is very low there is a high unmet need for better therapies. As we have recently shown, the positive predictive value (PPV) of using iCTCs as a screening test for patients who are at high risk, raises the PPV to well over 97%.”

LineaRx plans to work with existing companies in the diagnostic market and enhance the functionality and sensitivity of their cancer diagnostic assays. Longer term, the Vitatex platform is intended to be used to generate ultra-personalized redirected cell therapies, produced at the point of care, to cancers with high mutation burdens that also have the greatest metastatic potential. LineaRx intends to develop and out-license the technology as an early cancer diagnostic, and a prognostic to follow the course of contemporary cancer therapies including such redirected cell therapies as CAR T (T cells redirected against a patient’s cancer by an inserted nucleic acid that codes for Chimeric Antigen Receptors), and, to develop therapeutics that utilize LineaRx’s unique DNA manufacturing based upon large-scale polymerase chain reaction (PCR).

LineaRx intends to design synthetic genes to redirect immune cells against antigens that are recognized by leukocytes that comigrate with the iCTCs, one of the unique features of the Vitatex platform. Vitatex has been the beneficiary of more than $7 million of NCI funding over the course of its history, and LineaRx has already begun the application for a new contract to support commercialization, with matching funds from commercial partners. Dr. Chen continued, “We believe LineaRx has the commercial and compliance experience to bring our technologies quickly to commercial practice to aid the cancer community.”

Two senior members of the Vitatex team have joined the parent company of LineaRx, Applied DNA: Qiang Zhao, MD and Huan Dong, Ph.D. A Licensing Agreement was also signed between LineaRx and The Research Foundation for The State University of New York, since the discoveries claimed in the licensed patents were made on the campus of Stony Brook University. Peter Donnelly, Associate Vice President for Technology Partnerships for Stony Brook University stated: “We are pleased to expand our relationship with one of our community’s most productive and insightful entrepreneurs. The management at LineaRx has the experience, technical and compliance insights, and indefatigable drive to bring these technologies to market quickly.”

The acquisition of Vitatex by LineaRx was structured as an “earn-out,” allowing LineaRx to realize value before paying for it. Initial payment comprised $300,000 worth of equity in LineaRx at a valuation of $25 million for LineaRx. Subsequent payments are milestone-based, rising to a maximum of $1 million in value, comprising a total of $800,000 in LineaRx equity (based on the then-current market capitalization of LineaRx) and $200,000 in cash.

Dr. Kenneth Kaushansky, senior vice president of Health Sciences for Stony Brook University, and Dean of the Renaissance School of Medicine, and himself an expert on myeloproliferative cancers, stated: “Dr. Chen has invented and patented a fundamentally new technology for the capture and subsequent analysis of CTCs. With much excitement, we have watched the commercial progress of that technology as it has developed via multiple rounds of highly competitive SBIR funding, here at the Stony Brook University Medical Center. As have many others, we have been fascinated by the potential for such CTC-based approaches to cancer diagnostics. But arguably, what has been generally lacking in the field of CTC diagnostics is the ability to capture such CTCs based on the functional characteristics of a tumor cell, which the Vitatex technology is uniquely positioned to deliver. The recent pairing with LineaRx will provide the opportunity to take the Vitatex CTC technology to the next level, in terms of manufacturing scale-up, ISO and cGMP validation and the direct coupling of the Vitatex technology to a wide range of “best in breed” DNA-based and protein-based diagnostic assay technologies, which LineaRx already supports with its other commercial partners.”

 

Dr. Hayward summarized: “Dr. Chen’s lifetime contribution to the understanding of the mechanisms of cancer metastasis are inestimable. We are very fortunate to be able to work with his team to evolve and commercialize these technologies to improve the lives of cancer patients.”

[1] https://www.globenewswire.com/news-release/2019/04/26/1810526/0/en/The-Worldwide-Market-for-Circulating-Tumor-Cells-CTC-to-2025-A-17-5-Billion-Opportunity.html

 

About LineaRx
LineaRx seeks to commercialize the biotherapeutic value of Applied DNA’s deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria.  Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture.

About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

Forward-Looking Statements
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to the risk that the acquisition will not be successfully integrated with LineaRx or that the potential benefits of the acquisition will not be realized, the Company’s  history of net losses, limited financial resources, limited market acceptance , the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, ability to maintain its NASDAQ listing in light of delisting notices received  and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 18, 2018, as amended, and our subsequent quarterly reports on Form 10-Q filed on February 7, 2019 and May 9, 2019, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

Investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
Program contact: Brian Viscount, 631-240-8877, brian.viscount@adnas.com
Web: www.adnas.com
Twitter: @APDN, @LineaRxDNA

LineaRx Receives Multiple Purchase Orders for Linear DNA for Use in Therapeutic Development

Orders Reflect Growing Interest across the Biotech Industry for Bacteria-Free, Plasmid-Free Therapies

STONY BROOK, NY. July 1, 2019 – LineaRx, Inc., a wholly-owned subsidiary of Applied DNA Sciences, Inc. (“Applied DNA or the Company,” NASDAQ: APDN), announced today that it has received multiple purchase orders, from several major developers of gene and cell therapies, for its proprietary and patented large-scale, polymerase-chain-reaction (PCR)-produced linear DNA. LineaRx believes this momentum reflects increasing interest across the biotech industry to pursue a cleaner, higher-performing alternative to plasmid DNAs that are produced by fermentation in bacteria.

Under these Phase 1 CRO (Contract Research Organization) agreements, the performance of linear DNA will be benchmarked by criteria such as gene expression, and cell viability, against existing data from DNA produced using plasmids. LineaRx will also optimize, produce, and purify the products as required for testing both in vitro and in vivo by our customers. Upon successful benchmarking, LineaRx expects these customers will proceed to Phase 2 studies that leverage additional LineaRx intellectual property to enhance expression levels or expression lifetimes to drive greater therapeutic performance, while optimizing costs.

“In a number of completed studies, our linear DNA has met or exceeded the performance of plasmid DNA, as measured by gene expression, cell viability, and immunogenicity,” stated Dr. James Hayward, president and CEO of LineaRx. “These new Phase 1 CRO studies will seek to establish the performance of our linear DNA with several significant biotech companies focused on gene and cell therapies, including those focused on adoptive cellular therapies as well as RNA-based therapeutics. This increasing interest that encompasses a broad spectrum of industry players is an early, yet important, endorsement of our view that our proprietary PCR technology offers the potential for improved outcomes relative to current plasmid and viral-vector production technologies.”

To produce the quantities of DNA required for therapeutics, plasmid DNA is grown in bacteria and requires a costly purification process in an attempt to remove bacterial and non-target plasmid DNA, as well as bacterial toxins, before the purified DNA is used. It is commonly known that residual unintended DNA may still be present worrisome concentrations in the final product. LineaRx intends to eliminate the risk associated with the presence of bacterial or unintended plasmid DNA in current therapies via its expertise in the design, manufacture and chemical modification of DNA by large scale PCR.

“We attribute the increase in CRO orders, from marquis companies, to the growing desire to eliminate the risk associated with the presence of bacterial or unintended plasmid DNA in their therapies,” added Hayward. “We expect these CRO projects will evolve to CMO (Contract Manufacturing Organization) orders as some of these customers, once through their pre-clinical work, will bring linear DNA-based therapies to clinical trial within the next 18 months.”

About LineaRx
LineaRx seeks to commercialize the biotherapeutic value of Applied DNA Sciences’ deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria.  Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture.

About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

 

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

Forward-Looking Statements
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance , the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, ability to maintain its NASDAQ listing and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 18, 2018 and our subsequent quarterly reports on Form 10-Q filed on February 7, 2019 and May 9, 2019, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
program contact: Brian Viscount, 631-240-8877, brian.viscount@adnas.com
web: www.adnas.comwww. linearxdna.com
twitter: @APDN, @LineaRxDNA

LineaRx Ships DNA to Support Therapy Development for Neurodegenerative Diseases

Interest in large-scale Linear DNA for nucleic-acid based therapies continues to rise

STONY BROOK, NY. June 26, 2019 – LineaRx, Inc. a wholly-owned subsidiary of Applied DNA Sciences, Inc. (NASDAQ: APDN), announced today that it has shipped multiple customized linear DNA amplicons to Evotec SE, a well-known therapeutic development company, to support their research efforts related to neurodegenerative diseases such as Huntington’s, Parkinson’s or Alzheimer’s disease. DNA amplicons are segments of DNA that can serve as templates to generate the RNA or more DNA necessary for nucleic acid-based therapies.

“LineaRx collaborated closely with the customer on the design, production and post processing of their unique amplicon specifications,” stated Dr. James Hayward, president and CEO of LineaRx. “Evotec SE, like a growing number of other cutting-edge biotech companies, sees value in evaluating linear DNA as a foundation for their research and recognizes the strengths of LineaRx in the design and large-scale production of linear DNA using LineaRx’s proprietary platform for DNA production by polymerase chain reaction (“PCR”). The amplicons will be evaluated by Evotec SE over the next few months.”

Our shipment to Evotec SE, in support of neurodegenerative disease therapy research, is representative of a growing number of therapy developers coming to LineaRx and placing research quantity orders to evaluate the benefits of linear DNA in their therapeutic development pipeline. Many of the disease targets would have been considered unapproachable by gene therapies only a short time ago.

“Our expertise in PCR, as well as our pathway to cGMP large scale production, makes LineaRx a valuable partner to those companies pursuing a plasmid-free path,” indicated Brian Viscount, Director of LineaRx. “We continue to see growing demand for linear DNA, in both double-stranded and single-stranded formats, across a wide variety of nucleic acid-based therapies. We have the research bandwidth and production capacity to respond to the increasing demand we are seeing.”

About LineaRx
LineaRx seeks to commercialize the biotherapeutic value of Applied DNA Sciences’ deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria. Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture.

About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

Forward-Looking Statements
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance , the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the uncertainly relating to its ability to maintain its NASDAQ listing and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 18, 2018 and our subsequent quarterly reports on Form 10-Q filed on February 7, 2019 and May 9, 2019, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

 

investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
program contact: Brian Viscount, 631-240-8877, brian.viscount@adnas.com
web: www.adnas.com
twitter: @APDN, @LineaRxDNA

LineaRx Anticipates Expansion in Diagnostics Market via Follow-on Order and New Linear DNA Amplicons for Additional Assays

Shipments for Follow-on Order Under Existing Supply Agreement Will Commence This Quarter

STONY BROOK, NY. May 21, 2019 – LineaRx, a wholly-owned subsidiary of Applied DNA Sciences, Inc. (NASDAQ: APDN), announced that it is in process of designing new, custom amplicons for an existing customer in the in vitro diagnostics market. The diagnostic assay is expected to be available and qualified in 2020, potentially resulting in increasing revenue from an existing supply agreement.

The company currently receives annual orders for large-scale DNA from this customer under a 5-year supply agreement executed in 2017.  The second annual purchase under the supply agreement was received earlier this year, and shipments will commence this quarter and continue for the following 3 quarters.  This purchase order yields revenue in excess of $500,000.

We believe linear DNA is ideal for diagnostic applications in that modifications to the target amplicon made through the PCR process are faster, more efficient and less costly than traditional chemical derivatization. The molecular diagnostics market is projected to reach $11.54 billion by 2023 from $7.10 billion in 2017 at a CAGR of 8.4% (MarketsandMarkets.com; May 2018).

“The request for LineaRx to provide a new linear amplicon for a future diagnostic assay is a testament to the merits of linear DNA as well as our large-scale production capabilities,” said Brian Viscount, Director of Product Management at LineaRx.  “If the amplicon is qualified by our customer, we expect recurring shipments under our supply agreement to increase in calendar 2020.”

About Applied DNA Sciences

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

 

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

Forward-Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance , the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 18, 2018 and our subsequent quarterly report on Form 10-Q filed on February 7, 2019, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

Contacts

investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
program contact:  Brian Viscount, 631-240-8877, brian.viscount@adnas.com 
web: www.adnas.com, www.linearxdna.com
twitter: @APDN, @LineaRxDNA

LineaRx Achieves Higher Expression and Survival Rates in Human T Cells Transfected Non-Virally with Linear DNA

STONY BROOK, NY. April 29, 2019 – LineaRx, Inc. ( the “Company”) a wholly owned subsidiary of Applied DNA Sciences, Inc. (NASDAQ: APDN), announced today that it has improved expression levels and survival rates of linear DNA constructs delivered without viruses or plasmids to human T cells. In collaboration with Avectas, a cell engineering technology business enabling the manufacture of cell therapies, LineaRx has achieved a greater than four-fold increase in cell survival, and a more than 50% increase in linear gene expression of a model amplicon. Results were presented by Avectas last week at the Cell & Gene Meeting on the Mediterranean, attended by more than 50 companies.

“We expect to achieve expression levels of LinCART19™ that will permit our analysis of tumor kill rates in vitro and in animal models, allowing us to complete our preclinical evaluation of this promising therapy,” said Dr. James Hayward, president and CEO of Applied DNA. “We can now see that therapeutic doses are well within our planned range of numbers of redirected T cells. In addition to the pursuit of our own therapies, we are being increasingly approached by companies who see the value of linear DNA in gene and redirected cell therapies.”

Dr. Michael Maguire, CEO of Avectas said, “This is an exciting example of how Solupore® non-viral cell engineering is being used in a next-generation therapeutic product candidate. Through a simpler cell engineering process, Solupore® technology will improve the efficacy and accessibility of such potentially curative products.”

In October 2018, LineaRx announced an exclusive North American licensing and research services agreement with iCell Gene Therapeutics (“iCell”) for an anti-CD19 CAR T therapy. Leveraging Applied DNA’s expertise in large-scale PCR-based production and chemical modification of DNA, LineaRx will utilize its non-viral, plasmid-free (NVPF) platform to develop and produce expression vectors for CAR T therapies, including its own anti-CD19 CAR T therapy candidate, LinCART19.

As presented at the LineaRx Analyst Day on December 6, 2018, the CAR-T gene construct upon which LinCART19 is based, led to 3 of 3 complete remissions in patients with acute lymphocytic leukemia (ALL) up to 9 months at a very-low-dose in a clinical trial conducted by iCell in China under local regulations. While these promising clinical results provide evidence in the value of the genetic code utilized, the CAR T cells were transfected via a viral vector. LinCART19 will utilize linear DNA transfected by non-viral delivery into T Cells.

The Company recently announced the first anti-CD19 expression in human T cells from a gene construct utilizing linear DNA produced via a scalable PCR manufacturing process. Without the use of viral vectors or plasmids, LineaRx’s NVPF manufacturing platform holds numerous potential advantages over existing viral/plasmid-based CAR T approaches offering the possibility of more efficient, affordable and safer gene therapies for patients.

About Avectas

Avectas is a cell engineering technology business, enabling the manufacture of cell therapies. Avectas’ technology, Solupore®, delivers advanced molecules such as mRNA, proteins and gene editing tools to a range of primary cell types including T cells for immuno-oncology and gene editing applications. Solupore® utilizes a membrane disruptive approach to rapidly deliver advanced molecules to cells. It is a simple, rapid and gentle process that yields superior engineered cells. Solupore® results in improved cell processing times and cell health relative to viral vectors and electroporation, leading to a more cost-effective manufacturing process. Avectas is currently partnering with immuno-oncology and gene editing businesses to deliver their proprietary molecules. Avectas is also seeking therapeutic molecules to in-license as the core of a therapeutic program.

About LineaRx

LineaRx seeks to commercialize the biotherapeutic value of Applied DNA’s deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria. Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture.

About Applied DNA Sciences

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

 

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

Forward-Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance , the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 18, 2018 and our subsequent quarterly report on Form 10-Q filed on February 7, 2019, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

Contacts

investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
program contact:  Brian Viscount, 631-240-8877, brian.viscount@adnas.com 
web: www.adnas.com, www.linearxdna.com
twitter: @APDN, @LineaRxDNA

Applied DNA Subsidiary LineaRx Achieves Biotech Industry First with Anti-CD19 Expression in Human CAR T Cells via Proprietary Non-Viral, Plasmid-Free Platform

Novel DNA Manufacturing Platform Seeks to Pioneer New Generation of Faster, More Affordable Cell-based Therapeutics for Patients

STONY BROOK N.Y., April 8, 2019 – Applied DNA Sciences, Inc. (NASDAQ: APDN) announced today that LineaRx, (the “Company”), its subsidiary focused on next-generation biotherapeutics, has achieved anti-CD-19 CAR (Chimeric Antigen Receptor) expression in human T Cells via its proprietary, non-viral, plasmid-free (NVPF) manufacturing platform. To the Company’s knowledge, this seminal event represents the first time that a human T cell has been shown to express an anti-CD19 CAR from a gene construct utilizing linear DNA produced via a scalable PCR (Polymerase Chain Reaction) manufacturing process. The Company views this development as an important option for all gene therapies that currently use virus-delivery platforms, but especially for immune-oncology therapies that use virus delivery of synthetic genes to redirect a patient’s T cells, known as CAR therapy.

LineaRx’s unique PCR-based manufacturing technology created the linear DNA amplicon encoding the anti-CD19 engager, and that construct was then electroporated into human T cells ex vivo.  Subsequent testing has yielded anti-CD19 expression from these engineered cells.  While these preliminary data are encouraging, overall levels of expression were initially low and LineaRx continues working on generating higher transfection levels using the patent-pending High Expression Amplicon (HEA™) and methods of transfection other than electroporation and will report further progress on this significant achievement as it emerges.

Dr. James A. Hayward, president and CEO of Applied DNA, stated: “Our goals are three-fold: 1) To establish the value of PCR-produced linear DNA as a platform for the rapid design and production of therapeutic nucleic acid constructs, including at the point of care; 2) To prove the improved safety and therapeutic value of NVPF production streams, which are distinct from industry-wide viral-based production; and, 3) To bring our NVPF-based anti-CD19 CAR T cell therapy to the clinic with a future partner.”

This accomplishment builds upon another first instance of engineering human T cells via a linear DNA amplicon produced, designed and manufactured via LineaRx’s PCR technology in late 2018.  The first instance demonstrated a linear DNA amplicon that contained the complete gene that encoded production of Green Fluorescent Protein (GFP). As seen in the microscope image below, the uptake and subsequent expression of the PCR-generated GFP gene fragment in hundreds of human T cells, facilitated by high-throughput electroporation, created a “constellation” of green fluorescent cells.

In October 2018, LineaRx announced the signing of an exclusive North American licensing and research services agreement with iCell Gene Therapeutics for an anti-CD19 CAR T therapy. Leveraging Applied DNA’s expertise in large-scale PCR-based production and chemical modification of DNA, LineaRx will utilize its NVPF platform to develop and produce expression vectors for CAR T therapies, including for LinCART19™, its non-viral, plasmid-free anti-CD19 CAR T drug candidate.

As discussed at the LinearRx Analyst Day in December 2018, the CAR-T gene construct upon which LinCART19 is based, led to 3 of 3 complete remissions in patients with acute lymphocytic leukemia (ALL) at 6 months after a single low-dose treatment in a clinical trial conducted in China under local regulations.  While these promising clinical results provide evidence in the value of the genetic code utilized, the CAR T cells were transfected via viral vector. LinCART19 will utilize linear DNA transfected by either electroporation, soluporation, or other mode of delivery into T Cells.

Without the use of viral vectors or plasmids, LineaRx’s NVPF manufacturing platform holds numerous potential advantages over existing viral/plasmid-based CAR T approaches offering the possibility of more efficient, affordable and safer gene therapies for patients.

Forward Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance , the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 18, 2018 and our subsequent quarterly report on Form 10-Q filed on February 7, 2019, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

About Applied DNA Sciences

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance , the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 18, 2018 and our subsequent quarterly report on Form 10-Q filed on February 7, 2019, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

About LineaRx

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance , the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 18, 2018 and our subsequent quarterly report on Form 10-Q filed on February 7, 2019, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

Contacts

program contact:  Brian Viscount, 631-240-8877, brian.viscount@adnas.com 
investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
web: www.adnas.com, www.linearxdna.com
twitter: @APDN, @LineaRxDNA

Applied DNA Subsidiary LineaRx and Takis/Evvivax Progress Linear DNA for Use as Cancer Vaccine Candidates
Collaboration to study antigen-specific immune responses aimed at achieving therapeutic effects

STONY BROOK, N.Y., March 1, 2019 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA”), a leader in large-scale PCR-based DNA manufacturing, announced today that LineaRx, Inc. (“LineaRx”), its wholly-owned subsidiary focused on next-generation biotherapeutics, will ship TK7 and ConTRT amplicons to Takis/Evvivax next week as part of the companies’ Joint Development Agreement (“JDA”) entered into in September 2018.

Per the JDA, LineaRx and Takis/Evvivax will jointly develop linear DNA expression amplicons for TK7 and ConTRT, two of Takis/Evvivax’s anti-cancer vaccine candidates, utilizing LineaRx’s validated linear DNA technology. Linear DNA amplicons carrying the DNA sequences for Takis/Evvivax vaccine candidates will be delivered to pre-clinical animal models via Takis/Evvivax’s proprietary electroporation technology.

In 2018, LinearRx and Takis/Evvivax’s collaboration showed immunogenicity in mice that were vaccinated with linear DNA against the human protein telomerase that is over-expressed in more than 85% of all cancers. “This year we are using ConTRT, an improved version of our telomerase vaccine and a unique personalized approach which includes an epitope-prediction pipeline and a delivery strategy to achieve an extremely effective cancer vaccine over what has been done previously,” said Dr. Luigi Aurisicchio, CEO of Takis/Evvivax. “Each expression amplicon will undergo rigorous quality subject matter testing, immunogenicity testing, followed by a tumor challenge, with results planned for publication later this year.”

 

“Our collaborations with Takis/Evvivax and other therapy developers are helping to validate LineaRx’s novel technology as a viable alternative to bacterially-produced plasmids, with the potential for increased patient safety and reduced costs, using new quality control protocols for large-scale PCR production at LineaRx. We believe that linear DNA and the establishment of new quality attributes for this new therapeutic field will change the way gene and immune therapies will be performed,” stated Dr. James Hayward, president and CEO of Applied DNA. “Our implementation of testing for new quality attributes will support our preparation to approach FDA to seek approval for clinical study. Our know-how in the fields of therapeutic linear DNA production and the standardized PCR platforms in use at LineaRx enable us to create novel expression amplicons. We are extremely pleased with the progress we are making with Takis/Evvivax under our JDA.”

About Applied DNA Sciences

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

About LineaRx

LineaRx seeks to commercialize the biotherapeutic value of Applied DNA’s deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria.  Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture.

In all forms of gene therapy, DNA exerts its influence from within the nucleus. Recombinant events for circular DNA are permanent and alter the genomes of the affected cells and their progeny. The fundamental challenge of all gene and cellular therapies is safety. Recent studies have elaborated “unintended consequences” when plasmid and viral vectors are combined that may pose future risks for treated patients.

When linear DNA enters the nucleus, it does not need to be incorporated into the genome in to be temporarily expressed as the intended proteins product. LineaRx posits that for the effectiveness of genetic vaccines or genetic immune therapies, transient expression may be sufficient.

Forward-Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to our history of losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 18, 2018 and our subsequent quarterly report on Form 10-Q filed on February 7, 2019 that is available at www.sec.gov. APDN undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

About Evvivax S.R.L. and Takis S.R.L.

EVVIVAX, whose name is derived from Engineered Veterinary Vectored Immunotherapy and Vaccines, is a spin-off of Takis Biotech. EVVIVAX pursues the discovery and development of innovative Therapeutic Veterinary Cancer Vaccines based on viral vectors and DNA platform technologies. EVVIVAX frontline candidates are two therapeutic cancer vaccines for canine tumors: Tel-eVax and Erb-eVax. EVVIVAX aims at translating scientific breakthrough achievements in Cancer Immunotherapy into marketed innovative products in Veterinary and subsequently in Human Oncology.

Visit www.evvivax.com for more information.

Takis is a Biotech Company created in November 2009 by a group of scientists from IRBM, a Research Center in near Rome, formerly part of the global network of Merck Research Laboratories (MRL). The group has more than 15 years of experience and an established track record in drug discovery in Oncology and is recognized for the conception and implementation of a number of innovative technologies. One of the main assets of Takis is the expertise in in vivo electro-gene-transfer, which can be used for a variety of clinically useful applications, from vaccine development to somatic gene therapy. Takis pipeline include four Cancer Vaccine candidates based on this technology. Takis is also actively involved in the generation of humanized monoclonal antibodies for use in Oncology and Infectious Diseases.

Visit www.takisbiotech.it for more information.

 

Contacts

program contact:  Brian Viscount, 631-240-8877, brian.viscount@adnas.com 
investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
web: www.adnas.com, www.linearxdna.com
twitter: @APDN, @LineaRxDNA

During the 90-minute technical presentation Dr. James Hayward, CEO of LineaRx, Dr. Michael Hogan, Vice President of Life Sciences and Dr. Stephen Hughes, Director of DNA Programs will address:

  • Collaborative data on PCR-produced anti-cancer (anti-telomerase) vaccine show immunogenicity in mice,

  • Licensed CAR-T Therapy; partner data to be presented show efficacy in animals and humans when delivered via plasmid and virus, which bodes well for the prospect of similar efficacy of corresponding linear construct under development,

  • The concept for adoptive cell therapies without delay: “Networked DNA-producing PCR devices informed by Artificial Intelligence and located in hospitals operating under cGMP”, and,

  • Proprietary IP should enable high levels of gene expression, self-transducing genes, transiently expressed genes without genomic integration; the sum of which should generate localized, in-hospital production of more effective adoptive cell therapies, faster, with a higher Therapeutic Index and a simpler mode of manufacture.

LineaRx Webinar Information

 

To participate in the LineaRx webinar, please follow the instructions below. Management will take questions from select invitees in the Q&A portion of the event.

 

To Participate:

 

Replay (available 1 hour following the conclusion of the live call through December 13, 2018):

 

“This Analyst Day webinar serves as an excellent platform from which to build awareness for LineaRx’s competitive advantages and user benefits to the biotherapeutics industry at large. Anyone currently utilizing plasmid DNA and/or virus to transduce cells, in the DNA/RNA vaccine space, involved in CRISPR as well as, CAR-T Therapy could benefit greatly from our technology,” stated Dr. Hayward.

About LineaRx

LineaRx seeks to commercialize the biotherapeutic value of Applied DNA’s deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria. Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture.

In all forms of gene therapy, DNA exerts its influence from within the nucleus. Recombinant events for circular DNA are permanent and alter the genomes of the affected cells and their progeny. The fundamental challenge of all gene and cellular therapies is safety. Recent studies have elaborated “unintended consequences” when plasmid and viral vectors are combined that may pose future risks for treated patients.

When linear DNA enters the nucleus, it does not need to be incorporated into the genome in to be temporarily expressed as the intended proteins product. LineaRx posits that for the effectiveness of genetic vaccines or genetic immune therapies, transient expression may be sufficient.

About Applied DNA Sciences

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and DNA mass production for diagnostics and therapeutics.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

Our common stock is listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

Forward-Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to our history of losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 28, 2017 and our subsequent quarterly reports on Form 10-Q filed on February 8, 2018, May 3, 2018 and August 13, 2018, which are available at www.sec.gov. APDN undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

Contacts

investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
media contact: Cheryl Schneider, DGI Comm, 212-825-3210, cschneider@dgicomm.com
program contact: Brian Viscount, 631-240-8877, brian.viscount@adnas.com
web: www.adnas.com, www.linearxdna.com
twitter: @APDN, @LineaRxDNA

LineaRx to Hold Analyst Day Webinar to Announce DNA Vaccine Preclinical Data and Efficacy of In-Licensed CAR T Therapy 
Management to Address the Potentially Critical Role of Its Platform in the Future of Gene Therapy, Vaccines and Adoptive Cell Therapies; Webinar Scheduled for December 6, 2018, 12:00 - 1:30 pm EST

STONY BROOK N.Y., December 4, 2018 – LineaRx, Inc., the biotherapeutics company based on the use of large-scale production of gene-sized DNA by Polymerase Chain Reaction (“PCR”) and dedicated to revolutionizing biotherapeutics for the masses in affordability, availability, time-to-market, and reducing the risk associated with virally mediated therapy, and a wholly-owned subsidiary of Applied DNA Sciences, Inc. (NASDAQ: APDN), announced today that it will host an Analyst Day via webinar on Thursday, December 6, 2018 at 12 p.m. to 1:30 p.m. EST.

Applied DNA Subsidiary LineaRx Provides Cost and Quality Advantages to Technogenetics Diagnostic Solutions 
Large-Scale Production of Linear DNA Shows the Best Lot-To-Lot Reproducibility and Sequence Accuracy for Kits Targeting Autoimmunity and Infectious Diseases

STONY BROOK, NY. November  7, 2018 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA”), the leader in large-scale PCR-based DNA manufacturing, announced today that LineaRx, Inc. (“LineaRx”  or the “Company”) has been providing linear DNA to Technogenetics (Shanghai Kehua Bio-Engineering Co., Ltd-KHB group) that produces and sells kits to detect autoimmunity and infectious diseases.

The purified, PCR-produced DNA is custom-made for Technogenetics and is used to prepare the basic component responsible for the diagnostic specificity of two kits: one kit is used for the determination of dsDNA autoantibodies and the other for an ANA (Anti-Nuclear Antibodies) Screen.

 

“During the kits’ development, the Technogenetics R&D laboratories tested several polynucleotides. Only the linear DNA from LineaRx demonstrated high lot-to-lot reproducibility and the correct sequence of the polynucleotide,” said Clara Pasini, R&D – Clinical Affairs Consultant at Technogenetics. “These attributes improve the efficiency of our quality control for incoming raw materials and improve the overall quality, accuracy and reproducibility of our products.”

The Technogenetics kits employing linear DNA, assist in the laboratory diagnosis of systemic rheumatic autoimmune diseases such as systemic lupus erythematosus (SLE), Sjögren’s Syndrome (SS), progressive systemic sclerosis (PSS), dermatomyositis/polymyositis (DM/PM) and/or mixed connective tissue disease (MCTD).

In particular, the anti-dsDNA antibodies have high diagnostic value as autoantibody markers in patients with SLE, and for this reason they are included in the SLE classification criteria of the American College of Rheumatology. [1] Their prevalence in SLE varies from 40 to 80% according to case study and assay method. Besides its diagnostic function, the anti-dsDNA assay can play an important role in monitoring the progression of SLE, especially in patients with lupus nephritis. This is closely associated with the pathogenetic role of the antibodies: exacerbation of SLE is preceded by a constant and progressive increase of the anti-dsDNA antibodies, followed by a sharp decline at the moment of clinical recrudescence, which is justified by glomerular deposition of high-avidity DNA/anti-dsDNA immune complexes. [2] For this reason, this assay is widely used in the diagnosis and monitoring of SLE.

The molecular diagnostics market is projected to reach USD 11.54 billion by 2023 from USD 7.10 billion in 2017 at a CAGR of 8.4%. (MarketsandMarkets.com; May 2018).

“DNA produced by LineaRx is used by a number of customers who have a diagnostic solution in the market. These customers use our linear DNA as a critical part of their assay or as positive control for device calibration,” said Brian Viscount, Director of Product Management at Applied DNA. “Last year we shipped multiple grams of our linear DNA to our diagnostic customers. Linear DNA enables our diagnostic customers to minimize Quality Control costs and to ensure product reliability and consistency across their customer base. We are actively marketing to expand this business through new account acquisition and increasing our value add to existing customers.”

  1. M Hochberg. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 1997; 40: 1725.
  2. AJG Swaak, R Smeenk. Detection of anti-dsDNA as a diagnostic tool: a prospective study in 441 non-systemic lupus erythematosus (SLE ) patients with anti-dsDNA antibody (anti-dsDNA). Am Rheum Dis 1985; 44: 245-51.
About Technogenetics

Technogenetics is an innovative company working in the immunodiagnostics and molecular genetics fields. Technogenetics acts as a point of reference in the medical and scientific communities, developing and providing efficient, effective, environmentally friendly diagnostic solutions and products to improve prevention, diagnosis and treatment of several diseases.

Thanks to its high and specific know-how in the IVD (in vitro diagnostics) field, Technogenetics has provided an increased boost to research activities and manufacturing capabilities.

Technogenetics operates in international markets with strong partners. Due to the cooperation with international partners and an internal sales force, Technogenetics is well-known and appreciated in the industry being focused to customer needs and able to propose innovative solutions and avant-garde products.

About LineaRx

LineaRx seeks to commercialize the biotherapeutic value of Applied DNA’s deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria. Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture.

About Applied DNA Sciences

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and DNA mass production for diagnostics and therapeutics.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

The Company’s common stock is listed on NASDAQ under the symbol APDN, and its warrants are listed under the symbol APDNW.

Forward-Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to our history of losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 28, 2017 and our subsequent quarterly reports on Form 10-Q filed on February 8, 2018, May 3, 2018 and August 13, 2018, which are available at www.sec.gov. APDN undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

Contacts

investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
media contact: Cheryl Schneider, DGI Comm, 212-825-3210, cschneider@dgicomm.com
program contact: Brian Viscount, 631-240-8877, brian.viscount@adnas.com
web: www.adnas.com, linearxdna.com
twitter: @APDN, @LineaRxDNA

Applied DNA Subsidiary LineaRx Licenses CAR T Candidate and Initiates Pre-Clinical Development of Non-viral, Plasmid-Free CAR T Manufacturing Platform 

Novel DNA Manufacturing Platform Pioneering a New Generation of Faster, More Affordable CAR T Therapeutics. Offering Available to CRO/CMO Customers

STONY BROOK, N.Y., October, 16, 2018 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), the leader in large-scale PCR-based DNA manufacturing, announced today that LineaRx, Inc. (“LineaRx”), its wholly-owned subsidiary focused on next-generation biotherapeutics, has initiated pre-clinical development of a non-viral, plasmid-free (NVPF) chimeric antigen receptor (CAR) modified T cell (CAR T) manufacturing platform which will be made available to CAR T developers worldwide. Concurrently, LineaRx announced the signing of an exclusive North American licensing agreement and research services agreement with iCell Gene Therapeutics, Inc. (iCell) under which iCell licensed to LineaRx an anti-CD19 CAR T therapy for non-viral delivery. LineaRx will utilize its NVPF platform, along with the in-licensed anti-CD19 CAR T therapy, to develop, manufacture and commercialize LinCART19, a non-viral, plasmid free anti-CD19 CAR T drug candidate.

“Since their initial FDA approval in 2017, CAR T therapies have shown unrivaled efficacy against several forms of cancer, but they remain extremely complex to manufacture and are often cost prohibitive,” stated Dr. James Hayward, president and CEO of Applied DNA. “With our expertise in the large-scale PCR-based production and modification of DNA constructs, we believe we are in a unique position to offer a disruptive, inexpensive and safer alternative to established CAR T manufacturing platforms that rely on viral vectors and plasmids. We are excited to have begun pre-clinical development of our NVPF CAR T manufacturing platform to enable a new generation of cell therapies, including our own LinCART19 CAR T therapy, and offering CAR T developers worldwide access to our manufacturing platform upon completion of development.”

Said Dr. Stephen Hughes, Director of DNA Programs at Applied DNA: “CAR T therapies are changing the treatment of cancer, but they must be affordable and accessible to all patients. We believe the approach of the LineaRx team will alter the manufacturing of these life-changing therapies, increasing the speed and safety of production, while lowering the costs.”

LineaRx believes its novel NVPF construction of CAR Ts provides a manufacturing format that would be attractive to many developers of these therapies. Despite costly and inefficient manufacturing platforms, the CAR T market is currently experiencing rapid growth and investment, with over $20 billion in recent M & A activity1, and is expected to yield a CAGR of 32.5% at least through 20282.

The NVPF LineaRx CAR T manufacturing platform under development leverages Applied DNA’s expertise in large-scale PCR-based production and chemical modification of DNA to produce expression vectors for CAR T therapy, without the use of viral vectors or plasmids. LineaRx believes that a NVPF CAR T manufacturing platform confers numerous potential advantages over existing viral/plasmid-based CAR T platforms, including:

  • Streamlined manufacturing processes will yield reduced cost and lead times, lessening patient morbidity and mortality through shorter “vein-to-vein” times. As seen in the registrational trials for Kymriah® (Novartis International AG) and Yescarta® (Kite Pharma Inc.), the two currently US FDA approved CAR T therapies, up to 31% of intended patients ultimately did not receive treatment primarily due to patient complications during disease progression which evolved during the long manufacturing time required or from manufacturing failures,3

  • Reduction in the risk of permanent genetic integration/recombination into target cells, reducing the risk of insertional mutagenesis,

  • The potential mitigation of some current CAR T therapy side effects such as cytokine release syndrome (CRS) and on-target off-tumor toxicity,

  • The eventual ability to target neoantigens (quickly enough to impact the patient), or the patient-specific protein mutations that accrue in an individual patient’s cancer, and other disease epitiopes beyond cancer, that will allow a patient’s immune system to be the instrument of diverse therapies, and,

  • The eventual ability to develop CAR T therapies at the point-of-care, obviating complex and burdensome distributed supply chains, and consequently, speeding therapy.

 

LinCART19 CAR T therapy, which targets the CD19 B cell surface protein expressed on nearly all B-cell malignancies, is the focus of a research agreement between LineaRx and iCell Gene Therapeutics. Development of LinCART19 will benefit from iCell Gene Therapeutics experience in bringing the virally transfected CD19 targeted CAR-T successful into human clinical study as well as their technological leadership in engineering novel, first in class adoptive cell therapies.

After recently announcing a cancer vaccine will utilize its technology, LineaRx is leveraging its NVPF manufacturing platform for its LinCART19 CAR T therapy. This demonstrates the potential breadth of the NVPF platform to produce various biotherapeutics, including gene and cellular therapies as well as vaccines, subject to FDA approval.

Dr. Hayward continued, “We believe our NVPF approach to generate important biotherapeutics without using viruses and plasmids using portable devices can redefine “bench to bedside” therapy. Our Linear DNA PCR devices can be located on site, so the supply chain will never leave the building. We anticipate partnering with other developers to generate fundamentally new drugs from CAR Ts, including using custom epitopes and neoantigens to help usher personalized cancer therapy from a dream to reality.”

BioInformant

2 Coherent Market Insights

Allogene Therapeutics, Inc.  Form S-1, filed September 14, 2018

CAR T Therapies

CAR T therapies are a revolutionary DNA based approach to destroy cancer cells by harnessing the power of a patient’s own immune system. CD19 is a protein that is expressed on the vast majority of B cell cancers. By targeting CD19 expressing B cells with CAR modified T cells, various B cell malignancies can be addressed. Since 2017, the FDA has approved two CAR T-based therapies targeting the CD19 epitope, opening a new frontier in the fight against cancer.

About iCell Gene Therapeutics, Inc.

iCell Gene Therapeutics is developing proprietary technologies and a pipeline of Chimeric Antigen Receptor (CAR) engineered cell therapies designed to be first in class, cost effective and life saving. Our development operations are focused on creative and efficient paths to bring novel, cost effective therapies to patients.  First in human clinical trials are ongoing in US & China, supported by our US research & development organization and a state-of-the-art GMP facility in Zhongshan to manufacture precision-based therapeutics.

About LineaRx

LineaRx seeks to commercialize the biotherapeutic value of Applied DNA’s deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria.  Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture.

In all forms of gene therapy, DNA exerts its influence from within the nucleus.  Recombinant events for circular DNA are permanent and alter the genomes of the affected cells and their progeny. The fundamental challenge of all gene and cellular therapies is safety.  Recent studies have elaborated “unintended consequences” when plasmid and viral vectors are combined that may pose future risks for treated patients.

When linear DNA enters the nucleus, it does not need to be incorporated into the genome to be temporarily expressed as the intended protein product. LineaRx posits that for the effectiveness of genetic vaccines or genetic immune therapies, transient expression may be sufficient.

About Applied DNA Sciences

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and DNA mass production for diagnostics and therapeutics.

We make life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion. The proprietary DNA-based “CertainT®” platform can be used to identify, tag, test, and track products, to help assure authenticity, origin, traceability, sustainability and quality of products.

SigNature® DNA describes the core technology ingredient that is at the heart of a family of uncopyable, security and authentication solutions such as SigNature® T and fiberTyping®, targeted toward textiles and apparel, BackTrac™ and DNAnet®, for anti-theft and loss prevention, and digitalDNA®, providing powerful track-and-trace. All provide a forensic chain of evidence, and can be used to prosecute perpetrators. Applied DNA Sciences is also engaged in the large-scale production of specific DNA sequences using the polymerase chain reaction.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

The Company’s common stock is listed on NASDAQ under the symbol APDN, and its warrants are listed under the symbol APDNW.

Forward-Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to our history of losses, limited financial resources, limited market acceptance and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 28, 2017 and our subsequent quarterly reports on Form 10-Q filed on February 8, 2018, May 3, 2018 and August 13, 2018, which are available at www.sec.gov. APDN undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

Contacts

investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
media contact: Cheryl Schneider, DGI Comm, 212-825-3210, cschneider@dgicomm.com
program contact: Brian Viscount, Executive Director Product Management, 631-240-8800, brian.viscount@adnas.com
web: www.adnas.com, www.linearxdna.com
twitter: @APDN, @LineaRxDNA

LineaRx Secures New RNA Therapeutics Customers for Contract Research Services

LineaRx offers simplified manufacturing path to RNA Biotherapeutics via linear DNA

STONY BROOK N.Y., October 1, 2018 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA), the leader in large-scale PCR-based DNA manufacturing, announced today that LineaRx, Inc. (“LineaRx” ” or the “Company”), its wholly-owned subsidiary focused on next-generation biotherapeutics, has secured multiple new developers of RNA therapeutics as customers for its Contract Research Organization (CRO) services,  utilizing large scale production of linear DNA by Polymerase Chain Reaction (PCR). LineaRx provides these clients a faster, safer and less expensive manufacturing approach for these important biotherapeutics as compared to traditional production methods.

As part of its recent formation, LineaRx subsumed the activities of Applied DNA as a CRO and Contract Manufacturing Organization (CMO) to the biotherapeutics market. LineaRx offers prospective customers and development partners with access to a unique portfolio of patented and proprietary linear DNA technologies designed to effectively optimize delivery, improve targeting, and extend expression of cellular and gene therapy products.

“With its extensive experience in the manufacture of nucleic acids, LineaRx is the ideal partner to support growing demand for research activities.  We are witnessing a rising number of requests from prospective customers as the industry becomes increasingly cognizant of the Company’s value-adding technology that can improve DNA or RNA therapeutics,” stated Dr. James Hayward, president and CEO of Applied DNA. “Over the next 3 months, LineaRx will provide GLP grade, custom DNA, to a number of customers developing RNA vaccines.  We are confident that the results will show LineaRx PCR-produced DNA is well suited for use in the production of RNA therapeutics”.

The RNA-based therapeutic market is rapidly expanding, and is expected to reach $1.2 billion, globally, by year 2020.[1] RNA biotherapeutics include both therapeutics and vaccines and are a relatively new class of drug. When used as a therapeutic, RNA can be utilized for protein production (mRNA based-therapeutics) or in an interfering capacity to inhibit gene expression (antisense/interfering RNA-based therapeutics). This duality of functionality of RNA allows RNA-based therapeutics to target a wide range of indications including cancer, AIDS, rare genetic disorders, neurodegenerative disorders and cardiovascular conditions.

RNA therapeutics are typically manufactured from a DNA template.  When done at scale, the DNAs have historically been obtained from the circular, plasmid DNA grown in bacteria. The circular DNA must be precisely nicked to become linear and must be purified to remove all bacterial toxins and bacterial DNA. In contrast, large-scale, PCR-produced linear DNA is now available as a CRO service from LineaRx. PCR methods are used by RNA developers during bench-scale development, so that RNA drug developers are imminently familiar with this form of DNA and are gratified by its availability in large scale from LineaRx.

“Bacteria used to produce the plasmids contain toxins and pyrogens, that can cause illness and fevers if present in the final therapeutic that is delivered to a patient,” commented Dr. Mike Hogan, VP of Life Sciences for Applied DNA. ”The strengths of LineaRx’s PCR products lie not only in our ability to produce them at scale, but also through their purity in containing only the DNA necessary for the targeted therapeutic function.”

[1] https://www.alliedmarketresearch.com/press-release/RNA-therapeutics-market-is-expected-to-reach-1-billion-globally-by-2020.html

About LineaRx

LineaRx seeks to commercialize the biotherapeutic value of Applied DNA’s deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria.  Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture.

In all forms of gene therapy, DNA exerts its influence from within the nucleus.  Recombinant events for circular DNA are permanent and alter the genomes of the affected cells and their progeny. The fundamental challenge of all gene and cellular therapies is safety.  Recent studies have elaborated “unintended consequences” when plasmid and viral vectors are combined that may pose future risks for treated patients.

When linear DNA enters the nucleus, it does not need to be incorporated into the genome to be temporarily expressed as the intended protein product. LineaRx posits that for the effectiveness of genetic vaccines or genetic immune therapies, transient expression may be sufficient.

About Applied DNA Sciences

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and DNA mass production for diagnostics and therapeutics.

We make life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion. The proprietary DNA-based “CertainT®” platform can be used to identify, tag, test, and track products, to help assure authenticity, origin, traceability, sustainability and quality of products.

SigNature® DNA describes the core technology ingredient that is at the heart of a family of uncopyable, security and authentication solutions such as SigNature® T and fiberTyping®, targeted toward textiles and apparel, BackTrac™ and DNAnet®, for anti-theft and loss prevention, and digitalDNA®, providing powerful track-and-trace. All provide a forensic chain of evidence, and can be used to prosecute perpetrators. Applied DNA Sciences is also engaged in the large-scale production of specific DNA sequences using the polymerase chain reaction.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

The Company’s common stock is listed on NASDAQ under the symbol APDN, and its warrants are listed under the symbol APDNW.

Forward-Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to our history of losses, limited financial resources, limited market acceptance and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 28, 2017 and our subsequent quarterly reports on Form 10-Q filed on February 8, 2018, May 3, 2018 and August 13, 2018, which are available at www.sec.gov. APDN undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

Contacts

investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
media contact: Cheryl Schneider, DGI Comm, 212-825-3210, cschneider@dgicomm.com
program contact: Brian Viscount, Executive Director Product Management, 631-240-8800, brian.viscount@adnas.com
web: www.adnas.com, www.linearxdna.com
twitter: @APDN, @LineaRxDNA

Applied DNA Subsidiary, LineaRx, Inc., Signs Joint Development Agreement with Takis and Evvivax to Develop Linear-DNA Based Anti-Cancer Vaccines

Collaboration Seeks to Develop PCR-produced Linear DNA as a Safer Expression Vector for Vaccines

STONY BROOK N.Y., September 20, 2018 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) announced today that LineaRx, Inc. (“LineaRx”), its wholly-owned subsidiary focused on next-generation biotherapeutics, has signed a Joint Development Agreement (the “Agreement”) with Takis S.R.L. and Evvivax S.R.L. (“Takis/Evvivax”), biotechnology companies focused on the discovery and development of DNA based anti-cancer vaccines for the human and animal markets, respectively.

Under the terms of the Agreement, LineaRx and Takis/Evvivax will jointly develop linear DNA expression vectors for two of Takis/Evvivax’s anti-cancer vaccine candidates utilizing LineaRx’s linear DNA technology. Linear DNA amplicons carrying the DNA sequences for Takis/Evvivax vaccine candidates will be delivered to preclinical animal models via Takis/Evvivax’s proprietary electroporation technology. Antigen-specific immune responses aimed at achieving therapeutic effects will be studied.

The previously announced collaboration between the companies has already shown promise of yielding immunity in mice that were DNA-vaccinated against the human protein telomerase, which is over-expressed in more than 85% of all cancers.

Dr. Luigi Aurisicchio, CEO of Takis/Evvivax stated: “We are excited to co-develop linear DNA expression vectors for our DNA vaccine candidates with LineaRx. Initial data from the use of LineaRx’s amplicons in our vaccine candidates is promising. The advantages of linear DNA over plasmids would provide a clear market edge over plasmid-based DNA sources. We look forward to a mutually beneficial collaboration”.

“This Agreement serves to validate LineaRx’s technology as critical and necessary to the field of biotherapeutics in its ability to deliver potentially powerful approaches to the treatments of chronic diseases,” stated Dr. James Hayward, president and CEO of Applied DNA. “Takis/Evvivax are ideal partners of LineaRx given their innovative anti-cancer vaccine candidates for both humans and animals together with their expertise in preclinical animal models.”

Dr. Hayward continued, “The use of PCR-produced linear DNA, as opposed to bacterially produced plasmids, is an innovative concept that provides the potential for increased patient safety, ease of manufacture and vaccine logistics, and reduced costs. Our know-how in the fields of bulk linear DNA production and in bioconjugate chemistry enable us to create novel and highly efficient expression vectors.”

With their stability at room temperature, low risk of infection or secondary illness, and stability during transportation, DNA vaccines overcome many of the undesirable properties of conventional vaccines. The global DNA based human vaccine market is expected to grow at a CAGR of 55% and reach a value of $2.7 billion by 20191. The global veterinary vaccine market is expected to reach $20.6 billion by 20212, with DNA based animal vaccines gaining rapid market share.

Takis/Evvivax emerged from a Merck-supported research center in Rome and has relationships across Big Pharma (http://www.takisbiotech.it/en/takis-services). The companies have agreed to seek sponsorship for their work together.

About LineaRx

LineaRx seeks to commercialize the biotherapeutic value of Applied DNA’s deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria.  Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture.

In all forms of gene therapy, DNA exerts its influence from within the nucleus. Recombinant events for circular DNA are permanent and alter the genomes of the affected cells and their progeny. The fundamental challenge of all gene and cellular therapies is safety. Recent studies have elaborated “unintended consequences” when plasmid and viral vectors are combined that may pose future risks for treated patients.

When linear DNA enters the nucleus, it does not need to be incorporated into the genome in to be temporarily expressed as the intended proteins product. LineaRx posits that for the effectiveness of genetic vaccines or genetic immune therapies, transient expression may be sufficient.

https://www.bccresearch.com/market-research/biotechnology/dna-vaccines-bio067b.html

https://globenewswire.com/news-release/2018/01/22/1298446/0/en/Worldwide-Veterinary-animal-Vaccine-Market-to-Surpass-USD-12-10-Bn-by-2021.html 

 

About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and DNA mass production for diagnostics, personalized medicine and therapeutics.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion. The proprietary DNA-based “CertainT®” platform can be used to identify, tag, test, and track products, to help assure authenticity, origin, traceability, sustainability and quality of products.

SigNature® DNA describes the core technology ingredient that is at the heart of a family of uncopiable, security and authentication solutions, targeted a wide range of industries, including but not limited to, pharmaceuticals and nutraceuticals, textiles and defense materials, and DNAnet®, for anti-theft and loss prevention, and digitalDNA®, providing powerful track-and-trace. Our products provide a forensic chain of evidence in large commercial ecosystems.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

About Evvivax S.R.L. and Takis S.R.L.

EVVIVAX, whose name is derived from Engineered Veterinary Vectored Immunotherapy and Vaccines, is a spin-off of Takis Biotech. EVVIVAX pursues the discovery and development of innovative Therapeutic Veterinary Cancer Vaccines based on viral vectors and DNA platform technologies. EVVIVAX frontline candidates are two therapeutic cancer vaccines for canine tumors: Tel-eVax and Erb-eVax. EVVIVAX aims at translating scientific breakthrough achievements in Cancer Immunotherapy into marketed innovative products in Veterinary and subsequently in Human Oncology.

Visit www.evvivax.com for more information.

Takis is a Biotech Company created in November 2009 by a group of scientists from IRBM, a Research Center in near Rome, formerly part of the global network of Merck Research Laboratories (MRL). The group has more than 15 years of experience and an established track record in drug discovery in Oncology and is recognized for the conception and implementation of a number of innovative technologies. One of the main assets of Takis is the expertise in in vivo electro-gene-transfer, which can be used for a variety of clinically useful applications, from vaccine development to somatic gene therapy. Takis pipeline include four Cancer Vaccine candidates based on this technology. Takis is also actively involved in the generation of humanized monoclonal antibodies for use in Oncology and Infectious Diseases.

Visit www.takisbiotech.it for more information.

Forward-Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to our history of losses, limited financial resources, limited market acceptance, shifting enforcement priorities of US federal laws relating to cannabis, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 28, 2017and our subsequent quarterly reports on Form 10-Q filed on February 8, 2018, May 3, 2018 and August 13, 2018, which are available at www.sec.gov. APDN undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

Contacts

investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
media contact: Cheryl Schneider, Dian Griesel Int’l, 212-825-3210, cschneider@dgicomm.com
program contact: Brian Viscount, 631-240-8877, brian.viscount@adnas.com
web: www.adnas.com
twitter: @APDN

Applied DNA Forms Wholly Owned Subsidiary, LineaRx, to Develop Large-Scale, PCR-Produced DNA for Biotherapeutics 

Subsidiary focused on next generation DNA-based biotherapeutics and powered by a portfolio of intellectual property

STONY BROOK N.Y., September 18, 2018 – Applied DNA Sciences Inc., (NASDAQ: APDN, “Applied DNA” or the “Company”), the leader in large-scale PCR-based DNA manufacturing, announced today the formation of LineaRx, Inc., a wholly owned subsidiary. Its purpose is to commercialize the Company’s extensive experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”) in the field of biotherapeutics, specifically gene and cellular therapies as well as vaccines.

The Company believes that the opportunity and markets for these biotherapeutics are substantial, and that its proprietary PCR technology offers the potential for improved outcomes relative to current plasmid and viral vector production technologies.

“We believe the launch of LineaRx will unlock significant value to the benefit of Applied DNA shareholders and to the world of healthcare. Our proprietary and patented approach to linear DNA manufacturing holds the promise to deliver more efficient, affordable and safer genetic therapeutics to a broad patient population,” said Dr. James Hayward, president and CEO of Applied DNA. “Unlike Applied DNA’s taggant business, in which the DNA is short and nonfunctional by design, LineaRx DNA sequences are long (gene-sized) and contain the control elements that allow their expression in cells after specialized delivery to the cells. The segregation between the divisions enables the companies to differentiate their product portfolios, business units, operations and regulatory affairs.”

The name LineaRx is derived from the Latin “linea” for “line,” and the symbol Rx, interpreted as “medicine” or “therapy.” “LineaRx” reflects that distinct form of DNA that results from PCR production for use in medicine. Such “linear DNA” is a form of DNA distinct from the circular form of DNA most commonly produced as plasmids that are grown in bacteria. The Company believes the addressable biotherapeutic markets for LineaRx include:

  1. gene therapy (more than 2,600 clinical trials globally today; global cell and gene therapy market projected to reach $12 billion by 20201);

  2. immuno-oncology (expected to grow to $3.8 billion by 20222); and,

  3. DNA vaccines (expected to reach $2.7 billion by 20193).”

 

Most gene therapies are based on plasmids, which are the extrachromosomal DNA found in bacteria. Plasmids are associated with the genes for antibiotic resistance, which can make their use risky. In addition, many non-linear DNA-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial genetic risks and are extremely time consuming and expensive to manufacture.

In all forms of gene therapy, DNA exerts its influence from within the nucleus. Recombinant events for viral delivery of plasmid DNA are permanent and alter the genomes of the affected cells and their progeny. In contrast, when linear DNA enters the nucleus, it does not need to be integrated into the genome to be temporarily expressed as the intended protein product. The Company believe that the non-recombinant nature of linear DNA based gene therapies will increase patient safety and therapeutic efficacy and will also ease the regulatory burdens associated with gene therapies.

Applied DNA will license multiple patents for therapeutic applications to LineaRx.  These patents include the rights to manufacture DNA via PCR, using Applied DNA’s proprietary and patented systems under cGMP conditions, including the capacity for remote control, that would allow rapid manufacture in a distributed network that could even include the battlefield, or within hospitals that practice gene therapies such as CRISPR or cellular therapies such as CAR T.

The Company believes the simplicity of manufacturing linear DNA via PCR, the ability to chemically modify linear DNA, the absence of bacterial contaminants, the elimination of the requirement for simultaneous manufacture of viral vectors, and the proximity to patients and the trained physicians and nurses required to deliver these therapies, may represent significant time savings that are valuable to successful patient outcomes for linear DNA-based therapies.

Dr. Clint Rubin, Director of the Center for Biotechnology at Stony Brook University stated: “LineaRx broadens the options for developers of gene and cellular therapies. Gene therapies without recombination are a great approach when it is possible to achieve therapeutic goals. The management of LineaRx are experienced pros and bring a much needed and timely asset to the biotech industry, fueling regional and NYS growth in bioscience technology development and commercialization.”

LineaRx will also subsume the current activities of Applied DNA as a Contract Research Organization (CRO) and Contract Manufacturing Organization (CMO) to the biotherapeutics market. “By segregating our markets, and differentiating our sales teams, we expect to be able to better focus our selling efforts,” continued Dr. Hayward. “LineaRx will provide prospective customers and development partners access to a unique portfolio of patented and proprietary linear DNA technologies designed to effectively optimize delivery, improve targeting, and extend expression of gene therapy products. By supplying value-adding technology to existing and new DNA and RNA therapeutics, LineaRx can offer improvements to its customers’ therapeutics.”

Over the past year, the Company has shipped >8,000 milligrams of PCR-produced linear DNA for use in Diagnostic and Therapeutic applications, and has completed, or is progressing through, key milestones of a growing number of therapeutics research contracts for companies producing DNA and RNA vaccines and adoptive cell therapies. Key milestones of success for these gene therapies are delivery of DNA effectively into a cell, expressing the gene product from that DNA and eventually demonstrating the desired clinical outcome.

Through these collaborative efforts, we have shown that linear DNA is effective in expression of genes in vivo. This accomplishment is among the first in which a linear DNA expression amplicon produced by PCR has demonstrated expression in vivo.

https://www.statista.com/statistics/687229/global-cell-and-gene-therapy-market-size/

2 Frost & Sullivan

3  https://www.bccresearch.com/market-research/biotechnology/dna-vaccines-bio067b.html

About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and DNA mass production for diagnostics, personalized medicine and therapeutics.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion. The proprietary DNA-based “CertainT®” platform can be used to identify, tag, test, and track products, to help assure authenticity, origin, traceability, sustainability and quality of products.

SigNature® DNA describes the core technology ingredient that is at the heart of a family of uncopiable, security and authentication solutions, targeted a wide range of industries, including but not limited to, pharmaceuticals and nutraceuticals, textiles and defense materials, and DNAnet®, for anti-theft and loss prevention, and digitalDNA®, providing powerful track-and-trace. Our products provide a forensic chain of evidence in large commercial ecosystems.

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Forward-Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to our history of losses, limited financial resources, limited market acceptance, shifting enforcement priorities of US federal laws relating to cannabis, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 28, 2017and our subsequent quarterly reports on Form 10-Q filed on February 8, 2018, May 3, 2018 and August 13, 2018, which are available at www.sec.gov. APDN undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

Contacts

investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
media contact: Cheryl Schneider, Dian Griesel Int’l, 212-825-3210, cschneider@dgicomm.com
program contact: Brian Viscount, 631-240-8877, brian.viscount@adnas.com
web: www.adnas.com
twitter: @APDN