Cellipont Bioservices, a cell therapy Contract Development and Manufacturing Organization (CDMO) and CellVax Therapeutics Inc., a clinical-stage biotechnology company focused on individualised cell-based immunotherapies, have announced a partnership expansion upon prior work on FK-PC101 - currently in a Phase II clinical trial for high-risk prostate cancer patients.

It will also 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, the company said in a statement.

FK-GI101 is based on CellVax's proprietary platform that utilises a patient's own tumour 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 personalised immune response against residual or recurring tumour cells.

Darren Head, CEO of Cellipont Bioservices said, “We're proud to deepen our collaboration with CellVax as they bring their pioneering platform into new and challenging indications. 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.”

Fernando Kreutz, Chief Executive Officer at CellVax Therapeutics said, “Expanding our partnership with Cellipont is a critical step in scaling our personalised 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.”