- Theragent produces first cancer vaccine batch for CellVax Therapeutics’ Phase 2 trial.
- FK-PC101 aims to reduce prostate cancer recurrence post-prostatectomy.
Theragent Inc., a contract development and manufacturing organisation (CDMO) for cell-based therapies, announced it has successfully produced the first batch of autologous cancer vaccine for CellVax Therapeutics Inc. This vaccine will be used to dose the initial patient in CellVax’s Phase 2 clinical trial, evaluating FK-PC101, an immunotherapy for prostate cancer.
The trial, known as CELLVX-230, is investigating FK-PC101’s potential to reduce cancer recurrence in patients with high-risk prostate cancer post-prostatectomy. CellVax’s vaccine uses the patient’s own tumour cells, collected during surgery and modified to express MHC Class II, enhancing the immune response against tumour cells. The cells are then irradiated to prevent replication before being delivered back to the patient.
Theragent President and CEO Dr. Yun Yen expressed pride in the collaboration, stating, “We are thrilled to contribute to this achievement. It represents years of dedication and collaboration and a great deal of perseverance from all those involved.”
Conducted through a partnership with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), the Phase 2 trial involves multiple centres, with Dr. Scott Eggener of the University of Chicago as Principal Investigator. Theragent’s role covers comprehensive manufacturing, quality control, and clinical material distribution from its Arcadia, California facility.
According to CellVax CEO Fernando Kreutz, FK-PC101 offers a potential alternative to salvage radiotherapy or androgen deprivation therapy (ADT), treatments that may impact patients’ quality of life.
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