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 a 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, like 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 recurrency (Primary Endpoint: Disease-free survival (DFS) in men with localized prostate cancer after RP (Radical-Prostatectomy). 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 with locally advanced prostate cancer patients. Results from a Phase II clinical study provide evidence that at 4 years post-RP, 11.8% of the treated group had experienced recurrency, vs. 36.8% in the control group (p=0.0453, z-test). - Manuscript being submitted.

​

CellVax Therapeutics Initiated on October 2024 a Phase II (adaptive design) for patients with high-risk prostate cancer. (FK-PC101 (https://clinicaltrials.gov/study/NCT06636682))