Advaxis Truly Personalized Cancer Immunotherapy Moves Forward With Signing of an Exclusive Supply Agreement With Synthetic Genomics for Synthetic DNA
PRINCETON, N.J., March 09, 2016 (GLOBE NEWSWIRE) -- Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, and SGI-DNA, a wholly owned subsidiary of Synthetic Genomics, Inc. (SGI), today announced that the companies have entered into a five-year exclusive supply agreement. Under the terms of the agreement, SGI-DNA will manufacture for Advaxis synthetic DNA which will be used in Advaxis’ personalized Listeria monocytogenes (Lm)-based immunotherapy, known as MINE™ (My Immunotherapy Neo-Epitopes).
The goal of MINE™ is to use Advaxis’ Lm Technology™ to develop neo-epitope immunotherapies based on the specific and unique neo-epitopes found in an individual patient’s tumor. These neo-epitopes are built into DNA plasmids made exclusively by SGI-DNA for Advaxis and then inserted by Advaxis into patient specific immunotherapy constructs (ADXS-NEO), targeting the unique neo-epitope sequences identified in the patient’s tumor cells.
SGI-DNA's synthetic DNA business is built on scientific advancements and breakthroughs from leading scientists including J. Craig Venter, Hamilton Smith, Clyde Hutchison, Dan Gibson and their teams, and utilizes DNA technologies to produce complex synthetic DNA. SGI-DNA also offers the BioXpTM 3200 System, the world's first DNA printer, as well as a comprehensive suite of genomic services, including whole genome sequencing, library design, bioinformatics services, and reagent kits to enable synthetic biology.
"SGI-DNA is unparalleled in its commitment to innovative science, genomic services, bioinformatics and their ability to support DNA synthesis of components of Advaxis Lm immunotherapies," said Daniel O'Connor, President and Chief Executive Officer of Advaxis. "Our work with SGI-DNA will assist us in the development of our Lm Technologies™ and our innovative work with neo-epitopes to move us toward our planned filing of an Investigational New Drug Application later this year."
"We are excited to work with the Advaxis team and support their research and development program," said Nathan Wood, President of SGI-DNA. "We believe that SGI’s technical expertise in gene synthesis will help Advaxis meet its goal of making practical and effective personalized neo-epitope based treatments available for patients with cancer.”
SGI-DNA's proficiency with genomic sequencing, synthesis, and bioinformatics will factor in Advaxis' current MINE™ research with Memorial Sloan Kettering Cancer Center (MSK).
About Advaxis, Inc.
Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage 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 a cancer antigen 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 human papillomavirus (HPV)-associated cancers and is in clinical trials for three potential indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted axalimogene filolisbac orphan drug designation for each of these three clinical settings. Advaxis has two additional immunotherapy products: ADXS-PSA in prostate cancer and ADXS-HER2 in HER2 expressing solid tumors, in human clinical development.
This media statement 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 immunotherapies. 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, 2015, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.
Released March 9, 2016