Advaxis, Inc. (ADXS) Launches cGMP Suite for Pharmaceutical Quality Manufacturing of Synthetic DNA for Advaxis

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Synthetic Genomics Launches cGMP Suite for Pharmaceutical Quality Manufacturing of Synthetic DNA for Advaxis’ Clinical Trials

“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.

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