Theragent and CellVax Begin Phase 2 Trial for FK-PC101 with Initial Patient Dosed

ARCADIA, Calif., Nov. 11, 2024 /PRNewswire/ -- Theragent Inc., an advanced Contract Development and Manufacturing Organization (CDMO) specializing in next-generation cell-based therapies, has achieved a notable milestone alongside its sponsor client, CellVax Therapeutics Inc. Recently, Theragent successfully produced the initial batch of an autologous cancer vaccine aimed at dosing the first patient in CellVax Therapeutics' Phase 2 clinical trial for FK-PC101.

Dr. Yun Yen, President and CEO of Theragent, expressed enthusiasm over this achievement, emphasizing the years of dedication and collaboration involved. Dr. Yen extended gratitude to CellVax CEO Fernando Kreutz for entrusting Theragent with this critical task. "Theragent is dedicated to advancing cell therapy products, not just for CellVax but for the broader healthcare community. Our company was founded to bring transformative treatments to patients in need," Dr. Yen stated.

FK-PC101 is an innovative personalized cancer immunotherapy developed by CellVax, designed to assist prostate cancer patients at high risk of recurrence post-prostatectomy. The treatment involves collecting the patient’s tumor cells during surgery, which are then sent to Theragent’s CGMP facility for modification. These cells are altered to display Major Histocompatibility Complex (MHC) Class II on their surfaces, irradiated to render them replication incompetent, and subsequently used as personalized immunotherapy.

Fernando Kreutz highlighted the ongoing challenges in prostate cancer treatment, noting that despite advances in radiation, surgeries, and other therapies, up to 30% of patients may face recurrent prostate cancer following prostatectomy. Current standard treatments for recurrence, such as salvage radiotherapy and androgen deprivation therapy (ADT), can significantly affect the patient’s quality of life. Kreutz suggested that FK-PC101 might delay or even prevent the need for these treatments.

The clinical trial, CELLVX-230, is a multicenter, adaptive, Phase 2 randomized, open-label study evaluating the efficacy of the irradiated autologous cellular vaccine in men with high-risk prostate cancer post-radical prostatectomy. This trial is being conducted through a 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 oversees the comprehensive manufacturing process, including the release and disposition of all clinical materials from its state-of-the-art CGMP cell therapy manufacturing facility in Arcadia, CA.

CellVax Therapeutics Inc. is a private clinical-stage company engaged in the research, development, and innovation of individualized cell-based immunotherapies. The company has pioneered a proprietary platform for personalized cancer immunotherapy that activates the immune system to identify and destroy new targets on tumor cells.

Theragent is committed to accelerating scientifically complex cell- and tissue-based therapies for cancer and other diseases with unmet medical needs. Operating from their cutting-edge CGMP facility, Theragent offers extensive end-to-end manufacturing and testing capabilities for both clinical and commercial applications. The company prides itself on a skilled scientific team and a strong emphasis on quality, safety, and advanced manufacturing techniques, aiming to deliver valuable solutions for clients in both pre-clinical and clinical trial phases.

The Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC) is an investigator network of over 650 members across more than 300 clinical sites in the U.S. and Canada. This alliance, comprising leading academic and community-based uro-oncologists, is dedicated to advancing research in bladder, prostate, and renal cancers. The SUO-CTC operates as a registered not-for-profit corporation and maintains a cooperative relationship with the Society of Urologic Oncology (SUO).