CellVax Therapeutics Announces FDA Clearance of IND Application for FK-PC101, a Novel Personalized Cancer Immunotherapy

ARCADIA, Calif., Jan. 29, 2024 /PRNewswire/ -- Theragent Inc., a comprehensive CDMO focused on advancing next-generation cell-based therapies, has announced that its sponsor client, CellVax Therapeutics Inc., received clearance of its Investigational New Drug application (IND) by the U.S. Food and Drug Administration (FDA) for FK-PC101. Patient recruitment for the randomized Phase II trial will begin in March of 2024, with first patient treatments expected in Q2 2024.

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 patient's own tumor cells which are collected during surgery, then modified in the laboratory. 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. Fernando Kreutz, CEO at CellVax, stated, "We are thrilled to receive FDA clearance of our FK-PC101 IND. We have worked diligently throughout the pre-IND and IND process with our reliable partner Theragent, as well as our other consultants, who have brought process development expertise, regulatory know-how, and alignment with our core values. As CellVax reaches this important milestone, it represents over 20 years of work from discovery to clinical development, creating a new class of therapy for the most in-need patients."

The trial, CELLVX-230, is a randomized, multicenter, open-label study of irradiated autologous cellular vaccine in men with high-risk prostate cancer post-radical prostatectomy. It will be 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. Patient recruitment will begin in March 2024, with a goal of up to 230 participants sourced from 21 pre-selected sites across the US. Theragent will be 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. "We are tremendously excited to partner with CellVax on this clinical trial. Theragent was founded specifically for this purpose – to bring paradigm-changing treatments to patients in need," said Dr. Yun Yen, President and CEO of Theragent.

Despite recent improvements in radiation, surgeries, and other therapies, up to 30% of patients may still experience recurrent prostate cancer after prostatectomy. After recurrence, the current standard of care is salvage radiotherapy and/or androgen deprivation therapy (ADT). FK-PC101 could delay the necessity for such treatments, if not prevent it entirely. The primary clinical endpoint for CELLVX-230 will be disease free survival (DFS), with the secondary endpoint being increased time to next treatment (TTNT).

CellVax has high ambitions for FK-PC101 as the company gears up for the Phase II clinical trial. Looking forward, CellVax's corporate strategy has been specifically designed to ensure treatment accessibility. "We have thoughtfully assembled a disruptive corporate structure that could translate into a cost-effective cancer treatment for thousands of patients in the future," says Emerson von der Goltz, CellVax's Chief Financial Officer.

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