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.
Visit adnas.com for more information. Follow us on Twitter and
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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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190301005106/en/
program: Brian Viscount, 631-240-8877,
brian.viscount@adnas.cominvestors: Sanjay M. Hurry, LHA
Investor Relations, 212-838-3777, shurry@lhai.comweb:
www.adnas.com, www.linearxdna.comtwitter: @APDN,
@LineaRxDNA
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