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CellVax Selects Theragent as Manufacturing Partner for Phase 2 Clinical Trial for Prostate Cancer Immunotherapy

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CellVax Selects Theragent as Manufacturing Partner for Phase 2 Clinical Trial for Prostate Cancer Immunotherapy | Pharmtech Focus

Theragent, a cell therapy Contract Development and Manufacturing Organization (CDMO) focused on advancing next-generation cancer and rare disease treatments, has announced that they have been selected by CellVax Therapeutics to provide manufacturing and testing services for CellVax’s novel cancer immunotherapy candidate FK-PC101 entering Phase 2 clinical trials. FK-PC101 is a cell-based autologous cancer vaccine for prostate cancer patients who have a high risk of recurrence after prostatectomy.

Theragent and CellVax have started preparations for the manufacturing partnership, including project planning and analytical method tech transfer. Manufacturing services will commence in late 2022, for which Theragent has agreed to supply autologous cell-derived doses to support CellVax’s early and pivotal trials in the U.S.

“Theragent is a newer CDMO, but we have assembled a team that brings decades of experience in the development and production of autologous cell-based products around the world,” says Jeff Masten, Chief Operating Officer of Theragent. “We are thrilled to support CellVax and their promising Phase 2 cancer vaccine candidate. Not only does this project fit seamlessly into our new, state-of-the-art cGMP manufacturing facility in Southern California, but the incredible science behind FK-PC101 is a harmonious fit with our company mission of delivering advanced medicines to cancer patients in need.”

“Creating a new standard of care to treat solid tumors is what drives us at CellVax Therapeutics,” said Fernando Kreutz, MD/PhD, CEO of CellVax. “With our proprietary immunotherapy platform, we modify the patient’s tumor cells ex vivo, inducing them to behave as antigen-presenting cells, which are then formulated into a personalized cancer vaccine for that individual. We look forward to partnering with Theragent on the further development of this truly novel modality.”

CellVax will be studying and evaluating how FK-PC101 reduces the prostate-specific antigens (PSA) recurrence in patients with locally advanced prostate cancer after a radical prostatectomy (RP).

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