CaroGen, BioCentriq Enter Clinical Manufacturing Pact

CaroGen Corp. has selected BioCentriq for clinical manufacturing to support Phase 1 clinical trials of its lead immunotherapy candidate, CARG-201 which has been designed to generate multiple hepatitis B virus (HBV) antigens and to stimulate broad immune responses.

BioCentriq is a NJ-based full-service CDMO and offers process development and clinical manufacturing services for the cell and gene therapy industry along with a workforce development arm designed to help the industry adopt best practices in cell and gene therapy manufacturing.

CARG-201 is built based on the Artificial Virus for Infectious Diseases and Immuno-Oncology (AVIDIO) platform. AVIDIO of Virus-Like-Vesicles (VLVs) used by CaroGen are an artificial hybrid virus based on an alphavirus RNA replicon and glycoprotein from vesicular stomatitis virus.

“CaroGen’s mission is to develop transformative immunotherapies that will recognize and fight infectious diseases of unmet need, like those generated by HBV, that result in chronic liver conditions and cancer” said Bijan Almassian, Ph.D. and CaroGen’s co-founder and CEO. “We are thrilled to have received over $5 million funding from National Institute of Health (NIH) to support our HBV preclinical program and have the opportunity to engage an expert and innovative partner like BioCentriq to help validate our methods, further develop our manufacturing processes and ultimately produce high-quality clinical grade materials.”

“Our team is enthusiastic about the opportunity to help CaroGen scale up their technology and manufacture clinical grade materials that can be made available to the patients who need them the most” said Haro Hartounian, Ph.D., SVP and general manager of BioCentriq. “The work that CaroGen and the team at Yale University has done is truly impressive and we are honored to partner with them as they enter Phase 1 clinical trials.”