FK-PC101 is a novel personalized immunotherapy presenting patients own tumor neoantigens. It has a dual mode of action, being capable of activating both CD8+ cytotoxic T cells and CD4+ helper T cells, and thereby resulting in a strong and specific anti-cancer immune response. Upon injection, FK-PC101 will not only present a cancer neoantigen in the context of MHC I to naïve (unprimed ) CD8 + cytotoxic T cells, but also present the non-self antigen to CD4 + helper T cells in the context of MHC II.
FK-PC101 consists of autologous human cancer cells which have been modified ex vivo to express Major Histocompatibility Complex (MHC) II on their surface.
Cellvax Therapeutics plays an unique role in cancer immunotherapy by developing a platform that converts the patient's own cancer cells into an antigen-presenting state (“Tumor Presenting Cells”). The process involves cultivating tumor cells with a combination of cytokines in a specific media, which stimulates the de novo expression of MHC class II molecules on the surface of tumor cells. Solid tumor cells, similar to other non-immunological cells, do not naturally present MHC class II, a molecule critically responsible for peptide presentation to T helper cells to trigger an immune response. These modified tumor cells (“Tumor-Presenting Cells”) are then incubated with a foreign antigen, which is then internalized, processed, and displayed by the cells.
Cellvax Therapeutics will evaluate in Phase IIb FK-PC101´s reduction in PSA recurrences in men with localized prostate cancer after RP. In addition, Cellvax Therapeutics proprietary technology platform has applicability to other solid tumor treatments (e.g. breast, colon, pancreatic, others).
FK-PC101 is administered intradermal once weekly for 4 weeks, followed by inoculation once monthly for two months, and the last (seventh) inoculation three months after the last monthly dose. Phase I and II clinical trials were conducted in Brazil using patients presenting with local advanced or metastatic prostate cancer. Results from a Phase II clinical study provide evidence that at 4 years post-RP, 11.8% of the vaccine group had experienced PSA recurrence, vs. 36.8% in the control group (p=0.0453, z-test). - Manuscript being submitted.