Theragent Inc. and CellVax Therapeutics Inc. have announced a significant milestone with the first patient dosed in a Phase 2 clinical trial of FK-PC101, a novel personalized cancer immunotherapy. This trial represents a collaborative effort to advance cell-based therapies for prostate cancer patients at high risk of recurrence after prostatectomy.
FK-PC101: A Personalized Immunotherapy Approach
FK-PC101 is an autologous cancer vaccine derived from the patient's own tumor cells, collected during surgery and modified at Theragent's CGMP facility. The modification process involves expressing Major Histocompatibility Complex (MHC) Class II on the cell surface, followed by irradiation to render the cells replication-incompetent. This individualized immunotherapy aims to stimulate the patient's immune system to target and destroy residual cancer cells.
CELLVX-230 Trial Design
The Phase 2 trial, named CELLVX-230, is a multicenter, adaptive, randomized, open-label study. It is being conducted in partnership with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), with Dr. Scott Eggener from the University of Chicago serving as the Principal Investigator. Theragent is responsible for the end-to-end manufacturing, release, and disposition of all clinical material from its CGMP cell therapy manufacturing facility in Arcadia, CA.
Addressing Unmet Needs in Prostate Cancer Treatment
According to CellVax Therapeutics, despite advancements in prostate cancer treatments, up to 30% of patients experience recurrence after prostatectomy. Current standard of care for recurrence includes salvage radiotherapy and/or androgen deprivation therapy (ADT), which can lead to poorer health-related quality of life. FK-PC101 offers a potential alternative to delay or prevent the necessity for these treatments.
Fernando Kreutz, CEO of CellVax, stated that FK-PC101 could "delay the necessity for such treatments, if not prevent them entirely."
Manufacturing and Collaboration
Dr. Yun Yen, President and CEO of Theragent, expressed enthusiasm for contributing to this achievement, highlighting the years of dedication and collaboration involved. He thanked CellVax CEO Fernando Kreutz for his trust in Theragent's team and emphasized the company's commitment to advancing cell therapy products for the broader healthcare community.
