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Whitehawk Therapeutics Advances to Clinical Stage with IND Clearance for HWK-007 and Announces IND Submission for HWK-016
Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) 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 lu
About this update from Whitehawk Therapeutics, Inc.
[{"type":"text","content":"Actively recruiting Phase 1 trial for PTK7-targeted antibody-drug conjugate (ADC) HWK-007 ","length":89,"tagName":"p","attribs":{}},{"type":"text","content":"IND submitted mid-December 2025 for MUC16-targeted ADC HWK-016, anticipated Phase 1 start this quarter","length":102,"tagName":"p","attribs":{}},{"type":"text","content":"Initial clinical data from both programs anticipated in early 2027","length":66,"tagName":"p","attribs":{}},{"type":"text","content":"MORRISTOWN, N.J., Jan. 8, 2026 /PRNewswire/ -- Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) 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.","length":723,"tagName":"p"},{"type":"text","content":"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.","length":303,"tagName":"p"},{"type":"text","content":"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 (TOP1) inhibitor payload. Whitehawk expects to report initial clinical data from these trials in early 2027.","length":287,"tagName":"p"},{"type":"text","content":""These are important regulatory and execution milestones, underscoring the strength of our preclinical data and our ability to advance multiple programs in parallel," said Dave Lennon, PhD, President and CEO of Whitehawk Therapeutics. "At Whitehawk, we are taking a unique approach to the development of next-generation ADCs, combining validated tumor biology with a differentiated ADC architecture. Our platfor...