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

STONY BROOK, N.Y.--(BUSINESS WIRE)-- 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.

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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.

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