On December 20, 2023 Theragent Inc., a comprehensive CDMO focused on advancing next-generation cell-based therapies, reported that their sponsor client, CellVax Therapeutics Inc., has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for FK-PC101 (Press release, Theragent, DEC 20, 2023, https://theragent.com/cellvax-submits-ind-application-for-individualized-cell-based-immunotherapy-fk-pc101-with-support-of-theragent/ [SID1234638723]). CellVax and Theragent partnered in November of 2022, with CellVax seeking clearance to proceed with their Phase II adaptive design clinical trial.

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FK-PC101 is CellVax’s novel cancer immunotherapy, intended to treat prostate cancer patients who have a high risk of recurrence after prostatectomy. It consists of autologous human cancer cells that have been modified ex vivo to express major histocompatibility complex (MHC) 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 proud and excited for this IND submission of FK-PC101. This submission signals the next step in our company’s journey, and we are eager to initiate this adaptative Phase 2 trial for prostate cancer patients upon FDA clearance. In the future, we envision the CellVax technology may also be used to treat patients with other types of cancer. We are also grateful to our CDMO partner, Theragent, whose expertise enabled this IND submission."

Theragent provided contract services to CellVax, including process optimization, assay development, and regulatory affairs support while preparing the IND package for this novel compound. Dr. Yun Yen, President and CEO of Theragent, said, "The preparation of the CellVax IND filing is another celebratory milestone in our company’s history as we continue to fulfill our mission: advancing novel cancer therapeutics for patients in need." In 2020, there were an estimated 3.3 million people living with prostate cancer in the United States, and almost a quarter of those patients experience recurrence after a prostatectomy. In 2023 alone, the American Cancer Society estimates there were 288,300 new cases of prostate cancer, demonstrating the acute need for this therapeutic.

FK-PC101 utilizes the patient’s own cells to create specific Tumor Presenting Cells (TPC), which are then formulated into an individualized cancer immunotherapy. "We are proud to support CellVax and nurture this important immunotherapy on its clinical journey," continued Jeff Masten, Theragent’s Chief Operating Officer. "We thank our incredible technical team who contributed to this project. It was a true team effort that demonstrates Theragent’s comprehensive scientific and regulatory capabilities, which uniquely position us to advance even the most complex cell therapy modalities from the bench to the clinic."

Following the IND submission, CellVax is expecting the FDA’s response by February 2024. The target start date for the patient recruitment is March of 2024. Approximately 230 patients will be recruited from 20 sites across the United States. Theragent will be responsible for end-to-end manufacturing, release, and disposition of all clinical material.