Whitehawk Therapeutics says FDA clears IND application for HWK-007

Whitehawk Therapeutics (WHWK) announced that the U.S. FDA has cleared the Investigational New Drug application for HWK-007, its PTK7-targeted ADC. Whitehawk’s Phase 1 trial for HWK-007 is now actively recruiting and will initially evaluate activity in lung and ovarian cancers, two PTK7-expressing tumor types with established precedent data, as well as endometrial cancer, one of the highest PTK7-expressing tumor types. The company also announced the submission of an IND for HWK-016, its MUC16-targeted ADC, to the FDA in December 2025. A Phase 1 trial is anticipated to start recruiting this quarter and is expected to initially evaluate activity in two high MUC16-expressing gynecologic cancers, ovarian and endometrial. Both next-generation ADC programs leverage Whitehawk’s advanced ADC technology platform consisting of a highly stable yet cleavable linker that delivers a DNA Topoisomerase I inhibitor payload. Whitehawk expects to report initial clinical data from these trials in early 2027.