Whitehawk Therapeutics advances to clinical stage with IND clearance for HWK-007 and announces IND submission for HWK-016

CAR-T Digest - August 2020

8 January 2026: Whitehawk Therapeutics advances to clinical stage with IND clearance for HWK-007 and announces IND Submission for HWK-016

Whitehawk Therapeutics received FDA clearance for its PTK7-targeted ADC HWK-007, with a Phase 1, multicenter, open-label trial now actively recruiting patients with advanced solid tumors, initially focusing on lung, ovarian, and endometrial cancers
An IND for HWK-016, a next-generation ADC targeting membrane-bound MUC16, was submitted in December 2025, with a Phase 1 trial expected to begin recruitment this quarter in ovarian and endometrial cancers
Both programs use Whitehawk’s proprietary ADC platform featuring a highly stable yet cleavable linker, carbon-bridge cysteine re-pairing, and a DNA topoisomerase I (TOP1) inhibitor payload to enhance tumor targeting and reduce off-target toxicity
HWK-007 targets PTK7, an oncofetal pseudokinase overexpressed in ~70% of tumors, with no approved PTK7-directed ADCs currently on the market
HWK-016 is designed to avoid binding shed MUC16 (CA125) in circulation by selectively targeting the membrane-bound form, with initial clinical data from both ADC programs anticipated in early 2027 following regulatory clearance by the U.S. Food and Drug Administration