On January 8, 2026 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, reported 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.
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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 (TOP1) inhibitor payload. Whitehawk expects to report initial clinical data from these trials in early 2027.
"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 platform’s design features are intended to maximize tumor targeting while minimizing off-target toxicity, enabled by highly selective antibodies, a stabilizing bioconjugation strategy that includes carbon-bridge cysteine re-pairing, and controlled delivery of a potent TOP1 inhibitor payload. As our lead programs enter the clinic, our focus will be on efficient clinical execution to generate data that validates this approach with meaningful outcomes for patients."
About HWK-007
HWK-007 is a differentiated next-generation ADC targeting Protein Tyrosine Kinase 7 (PTK7). PTK7 is an oncofetal transmembrane pseudokinase that drives early embryonic development, has restricted expression in adult tissues and frequent overexpression in a wide range of cancers. PTK7 is the third most highly expressed tumor marker among clinically validated and emerging ADC targets, present in ~70% of tumors. There are no approved PTK7-directed ADCs.
HWK-007-101 is a Phase 1, multicenter, open-label study in adult participants that will employ a sequential dose-escalation and expansion design to evaluate the safety, pharmacokinetics and preliminary antitumor activity of HWK-007 in participants with advanced or metastatic solid tumors that are refractory to standard therapies.
About HWK-016
HWK-016 is a differentiated next-generation ADC targeting the membrane-bound portion of Mucin 16 (MUC16). MUC16 is a glycoprotein with low level of expression in normal adult tissues, and broad overexpression in gynecological tumors including ovarian, cervical and endometrial. In ovarian cancer, for example, MUC16 is present at rates up to 3-10 times higher than clinically validated and emerging ADC targets.
Shed MUC16 (CA125) is a validated biomarker for cancer screening and disease monitoring in gynecologic cancers. When ADCs bind to this cleaved portion of the MUC16 protein in circulation, it is cleared from the patient systemically rather than reaching the tumor. HWK-016 is designed to overcome this by directly targeting the membrane-bound, non-shed portion of MUC16.
HWK-016-101 is a planned Phase 1, multicenter, open-label study in adult participants that will employ a sequential dose-escalation and expansion design to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of HWK-016 in participants with advanced or metastatic solid tumors that are refractory to standard therapies.
(Press release, Whitehawk Therapeutics, JAN 8, 2026, View Source [SID1234661863])