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.