Synthetic Genomics, Inc. and Advaxis, Inc. have completed development and deployment of the first cGMP synthetic biology facility for the production of synthetic DNA constructs. The cGMP suite has been designed to meet Phase I clinical quality and manufacturing requirements mandated by the FDA. The suite will be used to develop synthetic DNA constructs for Advaxis’ upcoming Phase I trial of ADXS-NEO, a personalized, neoantigen-targeted cancer immunotherapy.
 
The suite is based on the BioXp 3200 System, the world’s first benchtop automated genomic workstation that customers can purchase in an expandable fashion, combined with Synthetic Genomics genome synthesis tools to manufacture precision DNA constructs. The facility is based at SGI-DNA, a subsidiary of Synthetic Genomics. 
 
Advaxis’ ADXS-NEO is a customized cancer treatment to stimulate an immune response against unique mutations contained in each individual patient’s tumor. Under strict cGMP process controls, Synthetic Genomics rapidly converts the genetic sequences of tumor-specific epitopes into synthetic DNA to create plasmid DNA targeting an individual patient’s cancer. Advaxis then combines the plasmid DNA with its 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.
 
"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., chief executive officer 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."
  
Daniel O’Connor, president and chief executive officer 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."