A cell therapy contract development and manufacturing organisation (CDMO), Theragent will provide manufacturing and testing services for CellVax’s therapy FK-PC101.
For the manufacturing partnership, Theragent and CellVax commenced preparations, which include project planning and analytical method tech transfer.
Manufacturing services are set to start late this year, for which Theragent will deliver autologous cell-derived doses to support the early and pivotal trials of CellVax in the US.
Theragent chief operating officer Jeff Masten said: “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.
“We are thrilled to support CellVax and their promising Phase II 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.”
In the trial, CellVax will examine and evaluate the way FK-PC101 reduces the recurrence of prostate-specific antigens (PSA) in patients with locally advanced prostate cancer following a radical prostatectomy (RP).
The cell-based autologous cancer vaccine FK-PC101 is intended for prostate cancer patients with a high recurrence risk after a prostatectomy.
CellVax CEO Fernando Kreutz said: “With our proprietary immunotherapy platform, we modify the patient’s tumour cells ex vivo, inducing them to behave as antigen-presenting cells, which are then formulated into a personalised cancer vaccine for that individual.”
Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.
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