On July 29, 2025 Cellipont Bioservices, a leading cell therapy Contract Development and Manufacturing Organization (CDMO) and CellVax Therapeutics Inc., a privately held clinical-stage biotechnology company focused on individualized cell-based immunotherapies, reported a partnership expansion upon prior work on FK-PC101 – currently in a Phase II clinical trial for high-risk prostate cancer patients – and will include cGMP manufacturing, drug substance and drug product technology transfer, and GMP facility preparation in support of FK-GI101, an autologous cell-based immunotherapy targeting gastric, pancreatic, and colon cancer and the current FK-PC101 trial (Press release, CellVax Therapeutics, JUL 29, 2025, View Source [SID1234654615]).
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FK-GI101 is based on CellVax’s proprietary platform that utilizes a patient’s own tumor cells harvested during surgery. These cells are modified in the lab to express MHC Class II molecules, enhancing visibility to the immune system. The cells are then irradiated to render replication-incompetent before being administered back to the patient to activate a personalized immune response against residual or recurring tumor cells.
"We’re proud to deepen our collaboration with CellVax as they bring their pioneering platform into new and challenging indications," said Darren Head, CEO of Cellipont Bioservices. "FK-GI101 represents a bold, patient-specific approach to immunotherapy in gastrointestinal cancers—areas with urgent unmet medical needs. At Cellipont, we are committed to providing the robust manufacturing infrastructure and expertise required to move such transformative therapies closer to patients."
"Expanding our partnership with Cellipont is a critical step in scaling our personalized immunotherapy platform. Their operational excellence and shared commitment to innovation make them the ideal partner as we advance FK-GI101 into the clinic. With their support, we are accelerating our efforts to deliver targeted, patient-derived treatments to those facing some of the most difficult-to-treat cancers," said Fernando Kreutz, Chief Executive Officer at CellVax Therapeutics.