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CellVax submits an IND application for an individualized cell-based immunotherapy, FK-PC101, with the support of Theragent

Thursday, December 21, 2023

Theragent Inc., a prominent Contract Development and Manufacturing Organization (CDMO) specializing in advancing cutting-edge cell-based therapies, recently announced that CellVax Therapeutics Inc., their partner, has formally submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for FK-PC101. This achievement follows the collaboration between CellVax and Theragent, initiated in November 2022, with the aim of obtaining clearance for CellVax's Phase II adaptive design clinical trial.

FK-PC101 is CellVax's innovative cancer immunotherapy designed for treating prostate cancer patients at high risk of recurrence post-prostatectomy. The therapy involves using autologous human cancer cells modified ex vivo to express major histocompatibility complex (MHC) II on their surface. These cells are rendered replication incompetent through irradiation and delivered as a personalized immunotherapy. Fernando Kreutz, CEO at CellVax, expressed pride and excitement for the IND submission, emphasizing its significance in advancing the company's journey. Kreutz looks forward to initiating the adaptive Phase 2 trial for prostate cancer patients pending FDA clearance, envisioning future applications of the CellVax technology for other cancer types.

Acknowledging the crucial role played by their CDMO partner, Theragent, Kreutz expressed gratitude for their expertise in enabling the successful IND submission. Theragent's contract services encompassed process optimization, assay development, and regulatory affairs support, crucial components in preparing the IND package for this groundbreaking compound. Dr. Yun Yen, President and CEO of Theragent, reflected on the achievement as a celebratory milestone in the company's commitment to advancing novel cancer therapeutics.

Highlighting the acute need for such therapeutic solutions, the American Cancer Society estimated 288,300 new cases of prostate cancer in 2023, with nearly a quarter of patients experiencing recurrence post-prostatectomy. FK-PC101 leverages the patient's own cells to create Tumor Presenting Cells (TPC), forming the basis of an individualized cancer immunotherapy.

Jeff Masten, Chief Operating Officer at Theragent, emphasized the collaborative effort within the company, showcasing their comprehensive scientific and regulatory capabilities. He expressed gratitude to the technical team for their contributions, highlighting Theragent's ability to advance complex cell therapy modalities from the laboratory to clinical settings.

Post-IND submission, CellVax anticipates the FDA's response by February 2024, targeting March 2024 for patient recruitment at 20 sites across the United States. Theragent will play a pivotal role in the end-to-end manufacturing, release, and disposition of all clinical material for the Phase II trial.



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