Synthetic Genomics Launches cGMP Suite
Synthetic Genomics and Advaxis announced 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.”