SAN DIEGO, June 1, 2017 /PRNewswire/ -- Synthetic Genomics,
Inc. and Advaxis, Inc. (NASDAQ:ADXS) announced today that they have
completed development and deployment of the first current good
manufacturing practice (cGMP) synthetic biology facility for the
production of synthetic DNA constructs. The cGMP suite has been
designed to meet cGMP Phase 1 clinical quality and manufacturing
requirements mandated by the FDA. The suite will be used to develop
synthetic DNA constructs for Advaxis' upcoming Phase 1 clinical
trial of ADXS-NEO, a personalized, neoantigen-targeted cancer
immunotherapy. At the core of the suite is the BioXp™ 3200 System,
the world's first benchtop automated genomic workstation that
customers can purchase in an expandable fashion, combined with
proprietary Synthetic Genomics genome synthesis tools to
manufacture precision DNA constructs. The facility is based at
SGI-DNA, a subsidiary of Synthetic Genomics.
"This cGMP suite marks the first application of Synthetic
Genomics' automated DNA synthesis directed to improve patient care,
and is a significant step towards moving synthetic biology from the
benchtop to the bedside," said Oliver
Fetzer, Ph.D., CEO of Synthetic Genomics. "The BioXp™ System
and this first-of-its-kind cGMP suite opens the door to precision
medicine, particularly when paired with the innovative technology
Advaxis has developed for directing immune response towards cancer
specific epitopes."
Advaxis' ADXS-NEO is a customized cancer treatment to stimulate
an immune response against unique mutations contained in each
individual patient's tumor. It begins with identifying neoepitopes
– non-synonymous mutations between a patient's healthy cells and
tumor cells. Using exome sequencing, a mutational map of the tumor
is developed to select a set of neoepitopes most likely to trigger
an immune response targeted at the cancer.
Under strict cGMP process controls, Synthetic Genomics rapidly
converts the genetic sequences of these tumor-specific epitopes
into synthetic DNA to create plasmid DNA targeting an individual
patient's cancer. Advaxis then combines the plasmid DNA with its
proprietary delivery system to generate large quantities of protein
containing neoepitopes that are taken up by a patient's antigen
presenting cells to activate a tumor specific T-cell response.
Daniel O'Connor, president and
CEO of Advaxis, said, "Synthetic Genomics pioneered a synthetic DNA
manufacturing process which has dramatically reduced turnaround
time, from several months to just a few weeks. This process makes
tailored immunotherapy feasible for critically-ill cancer patients
who don't have time to wait. We have been impressed by the
preclinical proof of concept work completed with Synthetic
Genomics, and look forward to moving ADXS-NEO into human clinical
trials."
About Advaxis, Inc.
Located in Princeton, N.J., Advaxis, Inc. is a
biotechnology company developing multiple cancer immunotherapies
based on its proprietary Lm Technology™.
The Lm Technology, using bioengineered live
attenuated Listeria monocytogenes (Lm)
bacteria, is the only known cancer immunotherapy agent shown in
preclinical studies to both generate cancer fighting T cells
directed against cancer antigens and neutralize Tregs and
myeloid-derived suppressor cells (MDSCs) that protect the tumor
microenvironment from immunologic attack and contribute to tumor
growth. Advaxis' lead Lm Technology immunotherapy,
axalimogene filolisbac, targets HPV-associated cancers and is in
clinical trials for three potential indications: Phase 3 in
invasive cervical cancer, Phase 2 in head and neck cancer, and
Phase 2 in anal cancer. The FDA has granted axalimogene filolisbac
orphan drug designation for each of these three clinical settings,
as well as Fast Track designation for adjuvant therapy for HRLACC
patients and a SPA for the Phase 3 AIM2CERV trial in HRLACC
patients. Axalimogene filolisbac has also been classified as an
advanced therapy medicinal product for the treatment of cervical
cancer by the EMA's CAT. Advaxis has two additional immunotherapy
products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2
expressing solid tumors, in human clinical development. In
addition, Advaxis and Amgen are developing ADXS-NEO, an
investigational cancer immunotherapy treatment designed to activate
a patient's immune system to respond against the unique mutations,
or neoepitopes, contained in and identified from each individual
patient's tumor, with plans to commence a Phase 1 clinical trial in
2017.
To learn more about Advaxis, visit www.advaxis.com and
connect on Twitter, LinkedIn, Facebook,
and YouTube.
Advaxis Forward-Looking Statement
This press release
contains forward-looking statements, including, but not limited to,
statements regarding Advaxis' ability to develop the next
generation of cancer immunotherapies, and the safety and efficacy
of Advaxis' proprietary immunotherapy, axalimogene filolisbac.
These forward-looking statements are subject to a number of risks
including the risk factors set forth from time to time in Advaxis'
SEC filings including, but not limited to, its report on Form 10-K
for the fiscal year ended October 31,
2016, which is available at http://www.sec.gov.
Any forward-looking statements set forth in this presentation
speak only as of the date of this presentation. We do not intend to
update any of these forward-looking statements to reflect events or
circumstances that occur after the date hereof other than as
required by law.
You are cautioned not to place undue reliance on any
forward-looking statements.
About SGI-DNA
SGI-DNA, a wholly owned subsidiary of
Synthetic Genomics Inc., provides genomic solutions to advance
scientific discovery. SGI-DNA's ever expanding suite of products,
services, reagents, bioinformatics tools and instrumentation
enables scientists to discover, design and build novel solutions
for basic research, as well as for biomedical and industrial
applications. SGI-DNA's genomic services include whole genome
sequencing, DNA synthesis, library design, bioinformatics, cell
engineering, and plasmid DNA cloning and purification. SGI-DNA's
reagents include a complete suite of Gibson Assembly® and Site
Directed Mutagenesis kits as well as optimized cell lines such as
Vmax™ a novel, fast growing host system for molecular biology. To
further enable synthetic biology workflows, SGI-DNA offers the
BioXp™ 3200 System. This fully automated genomics workstation
allows the creation of double stranded DNA fragments, automated
cloning, as well as Next Generation Sequencing DNA library
preparation. Building on scientific breakthroughs from
J. Craig Venter, Hamilton Smith, Clyde
Hutchison, Daniel Gibson and
their teams, SGI-DNA is committed to reducing barriers associated
with synthetic biology. More information is available at
www.sgidna.com.
About Synthetic Genomics
Synthetic Genomics is
programming the operating system of life to create sustainable
solutions for humankind's most pressing issues, from the wellbeing
of our population to the health of our planet. With an unmatched
understanding of how DNA drives the function of cells — the basic
biological units of all living organisms — Synthetic Genomics
modifies and writes genomes to enable transformative products in
the areas of vaccines, medicines, nutrition, and biotechnology
research. In addition to designing novel organisms that overcome
fundamental hurdles of scientific research and medicine, Synthetic
Genomics pursues partnerships with organizations seeking to
dramatically improve upon existing products in energy, health care
and other sectors. Continuing its legacy of scientific firsts in
genomics and synthetic biology, Synthetic Genomics is harnessing
the power of nature to improve quality of life. More information is
available at www.syntheticgenomics.com.
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SOURCE Synthetic Genomics, Inc.