Advanced therapeutics contract development and manufacturing organisation (CDMO) Theragent Inc announced on Monday that its has produced the first batch of autologous cancer vaccine to dose the first patient in its sponsor client CellVax Therapeutics Inc's randomised Phase 2 clinical trial for FK-PC101.

CellVax's novel personalised cancer immunotherapy is aimed at treating prostate cancer patients who have a high risk of recurrence after prostatectomy. It includes patient's own tumour cells that are collected during surgery, then modified at the Theragent CGMP facility. The modified cells express Major Histocompatibility Complex (MHC) Class II on their surface, which are then irradiated to make them replication incompetent and delivered as an individualised immunotherapy.

The trial is a multicentre, adaptive, Phase 2, randomised, open-label study of irradiated autologous cellular vaccine in men with high-risk prostate cancer post-radical prostatectomy. It is being conducted through a partnership with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), with Scott Eggener, MD (University of Chicago) as Principal Investigator. Theragent is responsible for end-to-end manufacturing, release and disposition of all clinical material out of its purpose-built, state-of-the-art CGMP cell therapy manufacturing facility in Arcadia, CA.