FG-3246

FG-3246 is a potential first-in-class, fully human ADC, being developed by Kyntra Bio for mCRPC 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 demonstrates very limited expression in most normal tissues, making it an ideal ADC 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.

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FG-3246 is currently in a Phase 2 monotherapy study in mCRPC, with initial data expected in the second half of 2026. As part of this program, Kyntra Bio is also evaluating FG-3180, a CD46-targeted PET imaging agent that uses the same antibody backbone as FG-3246. FG-3180 is being studied to assess its potential for identifying CD46-positive lesions and supporting predictive patient selection. FG-3246 and FG-3180 are investigational agents and are not approved for marketing by any regulatory authority.