CellVax Therapeutics Doses First Patient in Phase 2 Trial of Personalized Immunotherapy FK-PC101 for Prostate Cancer
Key Insights
CellVax Therapeutics (search) has dosed the first patient in a Phase 2 clinical trial of FK-PC101, a personalized immunotherapy for prostate cancer (search).
FK-PC101 utilizes the patient's own modified tumor cells to stimulate an immune response against recurrent prostate cancer (search).
The Phase 2 trial (CELLVX-230) is a multicenter, adaptive, randomized, open-label study in men with high-risk prostate cancer (search) post-prostatectomy.
CellVax Therapeutics (search) Inc. has announced the dosing of the first patient in its Phase 2 clinical trial (CELLVX-230) evaluating FK-PC101, a novel personalized cancer immunotherapy for prostate cancer (search). The trial is being conducted in partnership with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC). FK-PC101 aims to address the unmet need for effective treatments in patients with a high risk of recurrence after prostatectomy.
FK-PC101 is an autologous cancer vaccine derived from the patient's own tumor cells, collected during surgery and modified at Theragent (search)'s CGMP facility. The modification process involves expressing Major Histocompatibility Complex (search) (MHC) Class II on the cell surface, followed by irradiation to render the cells replication-incompetent. This individualized immunotherapy is designed to stimulate the patient's immune system to target and destroy residual cancer cells.
Addressing Prostate Cancer Recurrence
According to CellVax Therapeutics (search), up to 30% of patients experience recurrent prostate cancer (search) despite advancements in radiation, surgeries, and other therapies. Current standard treatments for recurrence, such as salvage radiotherapy and/or androgen deprivation therapy (ADT), can negatively impact patients' quality of life. FK-PC101 offers a potential alternative or adjunct therapy to delay or prevent the need for these treatments.
Fernando Kreutz, CEO of CellVax, stated that FK-PC101 could delay the necessity for salvage radiotherapy and/or androgen deprivation therapy (ADT), potentially improving patients' health-related quality of life.
Trial Design and Manufacturing
The CELLVX-230 trial is a multicenter, adaptive, Phase 2, randomized, open-label study involving men with high-risk prostate cancer (search) following radical prostatectomy. Scott Eggener, MD (University of Chicago) serves as the Principal Investigator. Theragent (search) 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.
Dr. Yun Yen, President and CEO of Theragent (search), expressed enthusiasm for contributing to this milestone, highlighting the years of dedication and collaboration involved. He also thanked CellVax CEO Fernando Kreutz for his trust in Theragent's capabilities.