Tumor Reduction Demonstrated in Vivo Using Two
Linear DNA Vaccines in Animal Models
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.
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, 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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version on businesswire.com: https://www.businesswire.com/news/home/20190919005074/en/
investors: Sanjay M. Hurry, LHA Investor Relations,
212-838-3777, shurry@lhai.com Program: Brian Viscount,
631-240-8877, brian.viscount@adnas.com web: www.adnas.com,
www.linearxdna.com twitter: @APDN, @LineaRxDNA
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