CellVax Announces Manufacturing Partnership with Theragent for Prostate Cancer Vaccine Trials

Anna Osborne
23 November 2022
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Late-stage clinical trial company CellVax Therapeutics has announced it is to partner with cell therapy Contract Development and Manufacturing Organization (CDMO) Theragent, Arcadia CA, – who will  provide CellVax with manufacturing and testing services for its novel prostate cancer immunotherapy product FK-PC101.

FK-PC101 is a cell-based autologous cancer vaccine, built upon CellVax’s proprietary immunotherapy platform, under clinical investigation for prostate cancer patients who experience a high risk of recurrence after prostatectomy. This therapy is due to enter into pivotal Phase II clinical trials in the U.S.

The trial aims to assess how well FX-PC10 – a personalized cancer vaccine produced through the ex vivo modification of patients’ tumor cells so that they behave as antigen-presenting cells specific to each patient and illicit a strong immune response – reduces prostate-specific antigen recurrence in patients.

“Creating a new standard of care to treat solid tumors is what drives us at CellVax Therapeutics[…]We look forward to partnering with Theragent on the further development of this truly novel modality,” said Fernando Kreutz, CEO of CellVax.

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Under the new agreement, Theragent will begin providing CellVax with manufacturing services and supply autologous cell-derived doses for the impending Phase II FK-PC101 trial, by late 2022. With project planning and analytical method tech transfer preparations are already underway.

The partnership enables CellVax’s early-phase trials to benefit from Theragents cGMP facility, end-to-end manufacturing, and, in-house testing capabilities, to ensure the safety and quality of FX-PC101 manufacturing.

“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,” commented Jeff Masten, COO of Theragent.

Source: Press Release

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