#United States #ADC #Morristown #Whitehawk Therapeutics #HWK-007

Whitehawk Therapeutics Advances to Clinical Development

Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage biotechnology entity focused on developing advanced cancer therapies, has recently made significant strides in its clinical endeavors. The company announced that the U.S. Food and Drug Administration (FDA) has granted clearance for the Investigational New Drug (IND) application for their lead product, HWK-007, a next-generation antibody-drug conjugate (ADC) targeting Protein Tyrosine Kinase 7 (PTK7). This milestone marks a crucial step for the company as it initiates Phase 1 trials evaluating the treatment's efficacy in lung and ovarian cancers.

Overview of HWK-007

HWK-007 represents a novel therapeutic approach, designed to target PTK7, prevalent in many cancer types. PTK7 is primarily involved in early embryonic development but shows overexpression in various tumors, putting it at the forefront as a target for cancer therapies. Approximately 70% of tumors express PTK7, and currently, there are no approved ADCs that specifically target this marker. The Phase 1 trial aims to assess the safety, pharmacokinetics, and preliminary antitumor activity of HWK-007 in adult patients with advanced solid tumors, particularly those who have shown resistance to existing treatments.

Launching HWK-016

In tandem with the advancements for HWK-007, Whitehawk announced the submission of an IND for HWK-016 in December 2025, targeted against Mucin 16 (MUC16). This ADC will focus on addressing gynecological cancers that exhibit high levels of MUC16 expression, including ovarian and endometrial cancers. HWK-016 is anticipated to enter Phase 1 trials shortly, further expanding Whitehawk’s arsenal against cancer.

MUC16, a glycoprotein, is overexpressed in numerous gynecological malignancies, making it a suitable target for ADC therapies. The innovative design of HWK-016 ensures effective delivery of a cytotoxic payload directly to cancer cells while minimizing healthy tissue exposure, addressing a major concern with existing ADCs.

Future Expectations

Both drug candidates utilize Whitehawk's advanced ADC technology platform, aimed at enhancing efficacy and tolerability in patients. Initial clinical data from these trials is expected in early 2027, providing insights into their therapeutic potential.

Dave Lennon, PhD, President and CEO of Whitehawk, articulated that these achievements signify not only regulatory progress but also the strength of their scientific data. He emphasized, "Our unique development approach for next-generation ADCs blends validated tumor biology with innovative ADC architectures designed to optimize tumor targeting while minimizing off-target effects."

Conclusion

Whitehawk Therapeutics stands poised to make a significant impact in the oncology space with its forward-thinking ADC therapies. The firm’s commitment to rigorous clinical standards and the focus on challenging cancers offers a beacon of hope for patients confronting difficult-to-treat conditions. As they advance through clinical trials, the outcomes hold promise not only for their drug candidates but for the future of cancer therapy as a whole.

For further information and updates on Whitehawk Therapeutics and its pipeline, you can visit their official website at www.whitehawktx.com.