Theragent and CellVax Therapeutics Announce First Manufacturing Batch in Phase 2 Trial of FK-PC101, a Novel Personalized Cancer Immunotherapy

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Nov 11, 2024, 18:37 ET

ARCADIA, Calif., Nov. 11, 2024 /PRNewswire/ -- Theragent Inc., a comprehensive CDMO focused on advancing next-generation cell-based therapies, has announced a significant milestone for both Theragent and its sponsor client, CellVax Therapeutics Inc. 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.

"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.

About CellVax Therapeutics

CellVax Therapeutics Inc. is a privately held clinical-stage company active in research, development, and innovation on individualized cell-based immunotherapies. CellVax Therapeutics has developed a proprietary personalized cell-based cancer immuno-therapy platform. A pioneer in developing a therapy that aims to activate the immune system to recognize new targets on tumor cells and destroy them. For more information, visit https://cellvx.com.

About Theragent

Theragent is an advanced therapeutics Contract Development Manufacturing Organization in Arcadia, CA, focused on accelerating scientifically complex cell- and tissue-based therapies for the treatment of cancer and other diseases with unmet medical needs. The company's innovative CGMP facility offers comprehensive end-to-end manufacturing and in-house testing capabilities for clinical and commercial purposes. With a skilled scientific team and an emphasis on quality, safety, and next-gen manufacturing, Theragent strives to provide value-added solutions for clients with challenging pre-clinical and clinical trial projects.

Theragent. Patients are waiting. For more information, visit https://theragent.com/

About SUO-CTC

Created, owned, and operated by its members, the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC) is a clinical research investigator network of more than 650 members from more than 300 clinical sites in the U.S. and Canada. This national alliance of leading academic and community based uro-oncologists is committed to furthering urology research in bladder, prostate and renal cancer. The SUO-CTC is a registered 501c3 not-for-profit corporation and has a cooperative relationship with the Society of Urologic Oncology (SUO).

For more information, visit https://suoctc.org.

SOURCE Theragent