Expanded Joint Development Agreement Serves as Basis for Preclinical Linear DNA Vaccine; Linear DNA Platform Will be the Production Framework
STONY BROOK N.Y., February 7, 2020 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions, nucleic acid-based biotherapeutic development, and liquid biopsies for cancer diagnostics, announced today and in a late-day Investor Call yesterday, that it has expanded its existing Joint Development Agreement (JDA) with Takis Biotech to include the preclinical development of a linear DNA vaccine against 2019-nCoV, the new coronavirus that originated in Wuhan, China, infecting more than 28,000 and killing hundreds in just weeks. The advantages posed by PCR-produced linear DNA for this challenge include the speed of production, the absence of antibiotics and their resistance genes, the purity of the DNA, the simplicity of design, the powerful immunogenicity proved in a prior linear DNA vaccine, the absence of any bacterial contaminants and the fact that the vaccine gene is effective without insertion into the patient’s genome.
The virus expanded its hosts to humans and has been declared a public health emergency by the World Health Organization (WHO) and by the U.S. Department of Health and Human Services (HHS). LineaRx, Inc. (“LineaRx”) is the majority-owned subsidiary of Applied DNA focused on the therapeutic and diagnostic applications of the Company’s large-scale PCR platform that is protected by multiple issued and pending patents.
“We have a patented and proprietary platform for the production of linear DNA that empowers rapid development and large-scale production that we believe will yield a safe and effective vaccine with fewer risks than other DNA production platforms,” said Dr. James Hayward, president and CEO of both Applied DNA and LineaRx. “As is typical for RNA viruses, coronaviruses mutate at rapid rates that require constant surveillance1. We believe that one of the many benefits of PCR-produced linear DNA is the rapidity at which a putative vaccine can be revised to accommodate mutational drift.”
Dr. Luigi Aurisicchio, CEO/CSO of Takis, stated, “Our collaboration under the JDA on genetic technologies has already shown the ability to induce powerful immune responses in animal models using linear DNA. To induce antibodies that can neutralize 2019-nCoV, it is essential to use reliable, effective technologies, that can be quickly adapted in the face of shifting pathogens. This global emergency requires a swift response.”
The companies are also developing a cancer vaccine that has shown rapid tumor clearance in test animals as reported this last September. Clinical trials using the linear DNA form of the cancer vaccine in companion animals are being planned. The Company has also participated in collaborative submissions for competitive contracts to develop related genetic countermeasures to protect American warfighters.
The collaborating teams have already begun the design and optimization of a synthetic gene that when delivered to muscles, should enable the temporary production of a designed antigen that could provoke an immune response against the virus. We expect to have linear DNA ready for testing within the next 60 to 90 days. Once the optimized gene is assembled, the Company will produce quantities of the linear DNA prototype vaccine at large scale for tests in mice. Prior evidence indicates that genes made of linear DNA reside only temporarily within the muscle cell nucleus, long enough to provoke an immune response, and is eventually cleared without genomic integration.
No commercial partner to take the coronavirus vaccine to market has been identified, nor is there any indication that the Company’s applications to develop countermeasures would be approved by regulators.
Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. R.Lu et alia. The Lancet. Published online: https://doi.org/10.1016/S0140-6736(20)30251-8
About Takis Biotech.
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.
About Applied DNA Sciences, Inc.
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, diagnostics 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.
About LineaRx, Inc.
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.
Visit www.takisbiotech.it for more information.
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform 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 possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, 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 or its partners 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 12, 2019 and our subsequent quarterly report on Form 10-Q filed on February 6, 2020, 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 or to reflect the occurrence of unanticipated events, unless otherwise required by law.
Sanjay M. Hurry, LHA Investor Relations
Brian Viscount, Applied DNA