MORRISTOWN, N.J. | October 24, 2025 — Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), an oncology-focused biopharmaceutical company pioneering next-generation antibody-drug conjugates (ADCs), announced compelling new data confirming Protein Tyrosine Kinase 7 (PTK7) as one of the most broadly expressed and clinically relevant targets across solid tumors. The findings, presented at the 2025 AACR–NCI–EORTC International Conference on Molecular Targets and Cancer Therapeutics, establish a strong foundation for Whitehawk’s lead ADC program, HWK-007, and underscore the company’s strategy to expand ADC applications beyond traditional tumor-specific indications.
Science Significance
The analysis, conducted in collaboration with Tempus AI, represents one of the largest real-world molecular evaluations of PTK7 expression to date. Drawing from more than 157,000 tumor samples, including nearly half from metastatic lesions, researchers demonstrated that PTK7 is expressed in approximately 70% of all solid tumors, positioning it as the third most highly expressed tumor marker among validated and emerging ADC targets, following HER2 and HER3. PTK7 expression remained stable across tumor histologies, disease stages, and metastatic status, underscoring its potential as a pan-tumor ADC target. The highest median PTK7 mRNA expression was observed in endometrial (7.4), ovarian (7.2), head and neck (7.1), non-small cell lung cancer (6.9), and breast (6.7) cancers. These findings support the broad translational relevance of PTK7 across multiple high-prevalence and hard-to-treat cancers. According to Dr. Grace Dy, Chief of Thoracic Oncology and Professor of Oncology at Roswell Park Comprehensive Cancer Center, “These results emphasize the translational potential of PTK7 as a stable and widely expressed target across solid tumors. By demonstrating consistent expression across stages and subtypes, this study builds a strong rationale for developing next-generation ADCs capable of reaching a broad patient population.”
Regulatory Significance
Whitehawk Therapeutics intends to submit an Investigational New Drug (IND) application for HWK-007 to the U.S. Food and Drug Administration (FDA) by year-end 2025. HWK-007 is a PTK7-directed ADC designed using Whitehawk’s proprietary next-generation ADC technology platform, featuring a highly stable, cleavable linker that delivers a Topoisomerase I (TOPO1) inhibitor payload. This IND submission represents a pivotal regulatory milestone, positioning HWK-007 as the first PTK7-targeted ADC to potentially advance into human clinical trials. The company’s near-term focus includes initiating Phase 1 clinical evaluation in non-small cell lung, ovarian, and endometrial cancers, indications where PTK7 expression is most pronounced. Regulatory experts anticipate that a successful IND clearance could establish a new therapeutic class in ADC development, complementing existing HER2- and Trop-2-targeted drugs while addressing patient populations with limited treatment options.
Business Significance
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The AACR–NCI–EORTC presentation reinforces Whitehawk Therapeutics’ leadership in ADC innovation, following its strategic transformation and rebranding from Aadi Bioscience earlier in 2025. The company’s pipeline now comprises three next-generation ADC assets, in-licensed under exclusive global development and commercialization agreements with WuXi Biologics. By validating PTK7 as a high-value target, Whitehawk strengthens its competitive position in the global ADC market—projected to exceed $25 billion by 2030. CEO Dave Lennon, PhD, commented, “These findings reinforce PTK7’s promise as one of the most compelling and underexplored ADC targets in oncology. With PTK7 expressed in approximately 70% of solid tumors, we see a significant opportunity to deliver a differentiated therapy for the nearly 750,000 U.S. patients who could benefit from a PTK7-directed ADC.” The company’s near-term objectives include advancing HWK-007 into clinical testing and progressing additional pipeline programs targeting SEZ6 and MUC16, both of which are associated with high unmet needs in oncology.
Patients’ Significance
The clinical importance of PTK7 lies in its restricted expression in normal adult tissues and frequent overexpression in cancer, making it an ideal ADC target for maximizing tumor selectivity and minimizing off-target toxicity. The study’s findings suggest that PTK7-targeted ADCs could benefit patients across multiple cancer types, from early-stage disease to metastatic progression. For patients with lung, ovarian, and endometrial cancers—diseases often associated with poor prognoses and limited durable treatment responses—HWK-007 represents a promising therapeutic innovation designed to offer potent antitumor activity with improved tolerability. By addressing PTK7’s broad expression profile, Whitehawk aims to bring ADC therapy to a substantially larger patient population than current single-indication ADCs allow.
Policy Significance
From a policy perspective, Whitehawk’s research underscores the value of data-driven, biomarker-based drug development—a priority area for both the FDA’s Oncology Center of Excellence and the Cancer Moonshot initiative. The collaboration with Tempus AI exemplifies the growing integration of AI-driven bioinformatics and real-world data in therapeutic discovery and validation. The findings align with federal initiatives encouraging precision medicine approaches that bridge genomics, proteomics, and clinical outcomes to accelerate targeted therapy approvals. As PTK7’s expression map becomes more clinically actionable, regulators and payers alike are expected to view pan-tumor ADCs as an efficient path to addressing cross-indication cancer burdens.
Transaction Highlights
Whitehawk Therapeutics (Nasdaq: WHWK) presented real-world molecular evidence confirming PTK7 as a major ADC target across solid tumors at the 2025 AACR–NCI–EORTC Conference. Conducted in partnership with Tempus AI, the analysis of over 157,000 tumor samples established PTK7 as the third most abundant tumor marker, expressed in ~70% of tumors, with stability across histologic and metastatic subtypes. The data strengthen the biological and clinical rationale for advancing HWK-007, a PTK7-directed ADC featuring a cleavable TOPO1 payload linker. The company expects to file an IND by year-end 2025, initiating clinical trials in lung, ovarian, and endometrial cancers. These developments reinforce Whitehawk’s leadership in ADC innovation, its commitment to biomarker-driven oncology, and its positioning within the next wave of precision cancer therapeutics.
Source: Whitehawk Therapeutics, Inc. Press Release
