FG-3246 is a potential first-in-class fully human antibody-drug conjugate (ADC), in-licensed from Fortis and being developed with FibroGen for metastatic castration-resistant prostate cancer and other tumor types. FG-3246 binds to a cell receptor target that internalizes upon antibody binding and is present at high levels in prostate cancer and other tumor types, but that demonstrates very limited expression in most normal tissues, making it an ideal ADC target candidate. FG-3246 is comprised of an anti-CD46 antibody, YS-5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. In both preclinical and phase I clinical studies Fortis has reported data to support additional clinical studies. The below clinical trials are being conducted by Fortis and UCSF.
Phase 1 Study of FG-3246 (FOR46) in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Phase 1b/2 Study of FG-3246 (FOR46) in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer