SAN DIEGO, CA — June 1, 2017 — 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.
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.
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.