FG-3246

FG-3246 is a potential first-in-class fully human antibody-drug conjugate (ADC), being developed by 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. FG-3246 has demonstrated efficacy against CD46-expressing tumors in both preclinical and clinical studies. FG-3246 is currently in two Phase I studies, being conducted by Fortis and UCSF, with initial data expected in the first half of 2024. We anticipate the initiation of the Phase II trial in metastatic castration-resistant prostate cancer in the second half of 2024. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority.