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