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.”
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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.
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.
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.