Whitehawk Enters Clinical Stage with Dual ADC Programs Targeting Difficult Cancers

MORRISTOWN, NJ – January 08, 2026 – Whitehawk Therapeutics (Nasdaq: WHWK) has officially transitioned into a clinical-stage company, marking a pivotal moment in its mission to develop advanced cancer therapies. The oncology firm announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for HWK-007, a highly targeted therapeutic aimed at a common cancer marker.

In a concurrent move demonstrating its platform's rapid development capabilities, Whitehawk also confirmed it submitted an IND application in late 2025 for a second compound, HWK-016. These advancements propel two of the company’s lead assets into human trials, a critical step in validating their potential against hard-to-treat solid tumors.

A Two-Pronged Clinical Assault

Whitehawk is wasting no time moving its lead candidate forward. The Phase 1 clinical trial for HWK-007, an antibody-drug conjugate (ADC) targeting Protein Tyrosine Kinase 7 (PTK7), is now actively recruiting patients. The initial study will focus on individuals with advanced or metastatic lung, ovarian, and endometrial cancers—malignancies where PTK7 is known to be frequently overexpressed and where significant unmet medical needs persist.

Following closely behind, the company anticipates launching a Phase 1 trial for HWK-016 this quarter. This second ADC targets MUC16, another well-established tumor antigen, and will initially be evaluated in patients with high MUC16-expressing gynecologic cancers, including ovarian and endometrial cancer. The company has set an ambitious but clear timeline, expecting to report the first clinical data from both programs 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. “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.”

Engineering a 'Smarter Bomb' for Cancer

At the heart of Whitehawk's strategy is its next-generation ADC platform, in-licensed from global biologics specialist WuXi Biologics. ADCs are often described as 'biological missiles' or 'smart bombs' because they are designed to deliver a potent cancer-killing chemical, or payload, directly to tumor cells while sparing healthy tissue. This is achieved by linking the payload to a monoclonal antibody that seeks out a specific protein, or antigen, found on the surface of cancer cells.

While the concept is powerful, first-generation ADCs have faced challenges, including instability in the bloodstream that leads to premature release of the payload, causing off-target toxicity and limiting the dose that can be safely administered. Whitehawk's platform aims to overcome these limitations through several key innovations.

Both HWK-007 and HWK-016 utilize a highly stable yet cleavable linker designed to keep the potent DNA Topoisomerase I (TOP1) inhibitor payload securely attached until it reaches the tumor. The company’s bioconjugation strategy, which includes a stabilizing technique known as carbon-bridge cysteine re-pairing, is engineered to prevent the ADC from breaking apart prematurely. This architecture is intended to maximize the therapeutic window—allowing for a higher dose to be delivered to the cancer while minimizing the side effects that have hampered older ADCs.

Targeting Cancer's Untapped Weaknesses

The promise of Whitehawk's technology is matched by its strategic choice of targets. Rather than competing in crowded areas, the company is focusing on antigens with significant biological validation but untapped therapeutic potential.

HWK-007 targets PTK7, a protein that is overexpressed in an estimated 70% of all tumors, making it one of the most prevalent cancer markers. Despite its ubiquity, there are currently no approved ADCs directed against PTK7, representing a major opportunity. Whitehawk's initial focus on lung, ovarian, and particularly endometrial cancer—one of the highest PTK7-expressing tumor types—is a calculated move to demonstrate proof-of-concept where the biological rationale is strongest.

Meanwhile, HWK-016 addresses a known challenge in targeting MUC16. This protein is the source of CA125, a famous biomarker used to monitor ovarian cancer. However, the MUC16 protein 'sheds' the CA125 portion into the bloodstream, creating a decoy that can intercept and neutralize ADCs before they reach the tumor. Whitehawk's HWK-016 is specifically designed to bypass this problem by targeting the portion of MUC16 that remains firmly anchored to the cancer cell's membrane. This innovative approach could unlock the full potential of MUC16 as a therapeutic target in ovarian, endometrial, and other gynecological cancers.

Navigating a Competitive and Lucrative Field

Whitehawk's clinical entry comes amid a renaissance in the ADC space, which has become one of the hottest areas in oncology drug development. Blockbuster successes like Enhertu from Daiichi Sankyo and AstraZeneca, and Padcev from Seagen (now part of Pfizer), have proven the immense clinical and commercial potential of next-generation ADCs, sparking a wave of investment and innovation across the industry.

The field is populated by pharmaceutical giants and agile biotechs alike, all racing to develop safer and more effective ADCs against a growing list of targets. By advancing two candidates with distinct mechanisms and targets, Whitehawk is positioning itself as a serious contender. The partnership with WuXi Biologics provides access to a proven, state-of-the-art technology platform, allowing Whitehawk to de-risk the manufacturing and chemistry aspects of development and focus its resources on what matters most: clinical execution.

The multicenter, open-label design of the upcoming Phase 1 trials will evaluate safety, pharmacokinetics, and preliminary anti-tumor activity in patients with advanced cancers who have exhausted standard therapies. The results, anticipated in early 2027, will be the first human validation of Whitehawk’s differentiated approach and will be watched closely by investors, competitors, and patient communities hoping for new lifelines against devastating diseases.