FibroGen publishes Phase 1 FG-3246 mCRPC data in JCO; ORR 20%, DCR 80%, mid-2025 Phase 2 start

KYNTRA BIO, INC.

Phase 1 study of FG-3246 (anti-CD46 ADC) in mCRPC published in Journal of Clinical Oncology.
Confirmed ORR 20%, DCR 80%, median rPFS 8.7 months in evaluable patients.
PSA50 response rate 36% in 39 evaluable patients; half of docetaxel-sensitive patients responded.
Safety profile consistent with MMAE ADCs; ocular AEs infrequent; MTD 2.7 mg/kg every 3 weeks.
Phase 2 monotherapy dose optimization to start by mid-2025; combo enzalutamide topline in 2H 2025.

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