SHARE NOW
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.
How are you enjoying this news article? Let us know your thoughts, here >>
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
While we have you…
We are continuously working to better optimize our content for you, our audience. Let us know how we’re doing by ticking the box below, or send us your feedback directly to team@phacilitate.com.
