Whitehawk Therapeutics Advances Two Next-Generation ADCs into Clinical Trials with FDA IND Clearances
核心洞察
Whitehawk Therapeutics (搜索) received FDA clearance for its PTK7 (搜索)-targeted ADC HWK-007 (搜索), with Phase 1 trials now actively recruiting patients with lung, ovarian, and endometrial cancers.
The company submitted an IND application for HWK-016 (搜索), a MUC16 (搜索)-targeted ADC designed to overcome limitations of existing approaches by targeting the membrane-bound portion of the protein.
Both next-generation ADCs utilize Whitehawk's advanced platform featuring a highly stable cleavable linker delivering a DNA Topoisomerase I (搜索) inhibitor payload.
Whitehawk Therapeutics (搜索) has achieved significant regulatory milestones with the FDA clearance of its Investigational New Drug (IND) application for HWK-007 (搜索), a PTK7 (搜索)-targeted antibody-drug conjugate (ADC), and the submission of an IND for HWK-016 (搜索), its MUC16 (搜索)-targeted ADC. The clinical-stage oncology company announced these developments on January 8, 2026, marking its transition into active clinical testing of next-generation cancer therapeutics.
Phase 1 Trials Begin for PTK7-Targeted Therapy
The FDA-cleared Phase 1 trial for HWK-007 (搜索) is now actively recruiting patients and will initially evaluate activity in lung and ovarian cancers, two PTK7 (搜索)-expressing tumor types with established precedent data, as well as endometrial cancer, identified as one of the highest PTK7-expressing tumor types. The HWK-007-101 study is designed as a multicenter, open-label trial employing sequential dose-escalation and expansion to evaluate safety, pharmacokinetics, and preliminary antitumor activity in participants with advanced or metastatic solid tumors refractory to standard therapies.
PTK7 (搜索) represents a compelling therapeutic target, functioning as an oncofetal transmembrane pseudokinase that drives early embryonic development while maintaining restricted expression in adult tissues and frequent overexpression across a wide range of cancers. According to Whitehawk, PTK7 is the third most highly expressed tumor marker among clinically validated and emerging ADC targets, present in approximately 70% of tumors, with no currently approved PTK7-directed ADCs available.
MUC16-Targeted ADC Addresses Unique Challenge
Whitehawk's second program, HWK-016 (搜索), targets a differentiated approach to MUC16 (搜索), a glycoprotein with low-level expression in normal adult tissues but broad overexpression in gynecological tumors including ovarian, cervical, and endometrial cancers. In ovarian cancer, MUC16 is present at rates up to 3-10 times higher than clinically validated and emerging ADC targets.
The company's strategy addresses a specific challenge in MUC16 (搜索) targeting: when ADCs bind to the shed portion of the MUC16 protein (CA125) in circulation, they are cleared systemically rather than reaching the tumor. HWK-016 (搜索) is engineered to overcome this limitation by directly targeting the membrane-bound, non-shed portion of MUC16.
Following the IND submission in mid-December 2025, a Phase 1 trial for HWK-016 (搜索) is anticipated to start recruiting this quarter, initially evaluating activity in two high MUC16 (搜索)-expressing gynecologic cancers: ovarian and endometrial.
Advanced ADC Platform Technology
Both programs leverage Whitehawk's advanced ADC technology platform, which consists of a highly stable yet cleavable linker that delivers a DNA Topoisomerase I (搜索) (TOP1) inhibitor payload. The platform's design features are intended to maximize tumor targeting while minimizing off-target toxicity through highly selective antibodies, a stabilizing bioconjugation strategy that includes carbon-bridge cysteine re-pairing, and controlled delivery of the potent TOP1 inhibitor payload.
"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 (搜索). "At Whitehawk, we are taking a unique approach to the development of next-generation ADCs, combining validated tumor biology with a differentiated ADC architecture."
Clinical Timeline and Expectations
Whitehawk expects to report initial clinical data from both trials in early 2027. The company's three-asset ADC portfolio is engineered to overcome the limitations of first-generation predecessors and is in-licensed from WuXi Biologics under an exclusive development and global commercialization agreement.
Lennon emphasized the company's focus on execution: "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."