FG-3246 Trials

FG-3246 is a potential first-in-class, fully human ADC, in-licensed from Fortis Therapeutics and currently under development by Kyntra Bio for mCRPC.

 

FG-3246 targets CD46, a cell surface receptor that internalizes upon antibody binding and is highly expressed in prostate cancer and other tumor types, while demonstrating very limited expression in most normal tissues. This expression profile makes it an ideal ADC candidate.

 

FG-3246 is comprised of an anti-CD46 antibody YS-5, linked to monomethyl auristatin E (MMAE), a clinically and commercially validated anti-mitotic ADC payload. Data from preclinical and phase 1 studies conducted by Fortis support the continued clinical investigation of FG-3246.

 

As part of the Phase 2 development program, Kyntra Bio is also evaluating FG-3180, a CD46-targeted PET imaging agent that uses the same antibody as FG-3246. The substudy is designed to assess FG-3180’s ability to detect CD46-positive lesions and explore its potential as a predictive tool for identifying patients most likely to benefit from FG-3246 therapy.