On November 11, 2024 Theragent Inc., a comprehensive CDMO focused on advancing next-generation cell-based therapies, reported a significant milestone for both Theragent and its sponsor client, CellVax Therapeutics Inc (Press release, Theragent, NOV 11, 2024, View Source [SID1234648085]). This past week, Theragent produced the first batch of autologous cancer vaccine to dose the first patient in CellVax Therapeutics’ randomized Phase 2 clinical trial for FK-PC101.
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"We are thrilled to contribute to this achievement," said Dr. Yun Yen, President and CEO of Theragent. "It represents years of dedication and collaboration and a great deal of perseverance from all those involved. My special thanks to CellVax CEO Fernando Kreutz for putting his faith in our team; Theragent is proud to advance cell therapy products for CellVax and the broader healthcare community. We were founded specifically for this purpose – to bring paradigm-changing treatments to patients in need," continued Dr. Yen.
FK-PC101 is CellVax’s novel personalized cancer immunotherapy intended to treat prostate cancer patients who have a high risk of recurrence after prostatectomy. It consists of the patient’s own tumor cells which 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 individualized immunotherapy.
"Despite recent improvements in radiation, surgeries, and other therapies, up to 30% of patients may still experience recurrent prostate cancer after prostatectomy," said Kreutz. "Further, after such recurrence, the current standard of care is salvage radiotherapy and/or androgen deprivation therapy (ADT), both of which may lead to poorer health-related quality of life for patients. FK-PC101 could delay the necessity for such treatments, if not prevent them entirely."
The trial, CELLVX-230, is a multicenter, adaptive, Phase 2, randomized, 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.