HWK-007 / Whitehawk Therapeutics, Hangzhou DAC Biotech, WuXi AppTec - LARVOL DELTA

Durable and Treatment-Agnostic PTK7 Expression in EGFR-Wild-Type Lung Adenocarcinoma Supports Targeted ADC Development (IASLC-WCLC 2026) - P1 | "In EGFR -wild-type lung adenocarcinoma, PTK7 expression is largely independent of that of other AGAs, suggesting a distinct patient population may benefit from PTK7-targeted therapy. HWK-007, a next-generation, PTK7-directed ADC, is currently being evaluated in a phase 1 clinical trial (NCT07444814) in patients with solid tumors, including non-squamous EGFR -wild-type NSCLC."

ADC • IO biomarker • Lung Adenocarcinoma • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • CD276 • EGFR • ERBB3 • KRAS • PTK7 • SLC34A2 • TACSTD2

Association Between PTK7 Expression and Real-World Survival in Pretreated Patients With EGFR-Wild-Type Lung Adenocarcinoma (IASLC-WCLC 2026) - P1 | "The relationship between PTK7 expression and survival will also be explored in the EGFR -mutant population. HWK-007, a novel PTK7-directed antibody-drug conjugate, is currently being evaluated in a phase 1 clinical trial in patients with solid tumors, including non-squamous EGFR-wild-type NSCLC (NCT07444814)."

Clinical • IO biomarker • Real-world • Real-world evidence • Lung Adenocarcinoma • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • PD-L1 • PTK7

A phase 1 study of HWK-007, a next-generation, protein tyrosine kinase 7 (PTK7)–targeted antibody-drug conjugate (ADC), in patients with advanced solid tumors. (ASCO 2026) - P1 | "Results from early clinical trials of cofetuzumab pelidotin, a PTK7-targeted, auristatin-based ADC, showed promising clinical activity. Secondary endpoints include pharmacokinetics and preliminary efficacy outcomes. Recruitment is underway; planned enrollment is up to 226 patients."

ADC • Clinical • First-in-human • Metastases • P1 data • Endometrial Cancer • Interstitial Lung Disease • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • EGFR • MUC16 • PTK7

Anticipated Milestones (PRNewswire) - "(i) HWK-206 - plan to submit an Investigational New Drug application to the U.S. Food and Drug Administration in mid-2026 for HWK-206 in small-cell lung cancer and neuroendocrine tumors; Phase 1 recruitment planned to start in Q3 2026; (ii) HWK-007 and HWK-016 - ongoing recruitment into Phase 1 trials, with initial results expected in 1H 2027."

IND • P1 data • Platinum resistant • Trial status • Endometrial Cancer • Lung Neuroendocrine Carcinoma • Neuroendocrine Tumor • Ovarian Cancer • Small Cell Lung Cancer

Preclinical assessment of HWK-007, a next-generation, PTK7-targeting ADC with novel bioconjugation and linker-payload technology (AACR 2026) - "Results from early clinical trials of cofetuzumab pelidotin, a PTK7-targeted, auristatin-based ADC, showed promising signs of clinical activity. In summary, HWK-007 is a highly potent and selective, next-generation, PTK7-targeted ADC. A phase I dose-escalation study is planned to evaluate HWK-007 in patients with advanced solid tumors."

ADC • Preclinical • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • PTK7

Preclinical assessment of HWK-007, a next-generation, PTK7-targeting ADC with novel bioconjugation and linker-payload technology (Poster #4439) (PRNewswire) - "Whitehawk Therapeutics presents comprehensive preclinical data highlighting its next-generation ADC portfolio at the AACR 2026....Key preclinical findings include: High‑affinity binding and efficient internalization across a range of PTK7 expression levels; Demonstrates potent binding, internalization and tumor cell-killing in a range of solid cancer cell lines; Exhibits bystander activity and produces tumor regressions at doses as low as 1 mg/kg in small cell lung cancer and ovarian cancer models."

Preclinical • Ovarian Cancer • Small Cell Lung Cancer

Whitehawk Therapeutics…announced it will present three preclinical abstracts, including an oral minisymposium and two posters, highlighting its next-generation antibody-drug conjugate (ADC) portfolio at the American Association for Cancer Research (AACR) Annual Meeting 2026 (PRNewswire) - "...'We will present comprehensive preclinical proof-of-concept for our three ADC programs, HWK-007, HWK-016 and HWK-206'....Whitehawk's comprehensive preclinical abstracts demonstrate a potential best-in-class therapeutic index among next-generation TOP1i-based ADCs. These data showed high potency with tumor regressions in xenograft studies at low single-digit mg/kg doses, and in non-human primate studies, Whitehawk's ADCs demonstrated a high tolerability with a highest non-severely toxic dose (HNSTD) of 60 mg/kg."

Preclinical • Solid Tumor

Whitehawk Therapeutics Reports…Recent Highlights (PRNewswire) - "Actively recruiting Phase 1 trials for PTK7-targeted antibody-drug conjugate (ADC) HWK-007 and MUC16-targeted ADC HWK-016. HWK-206 on track for planned IND submission in mid-2026 and Phase 1 start in Q3."

IND • New P1 trial • Trial status • Solid Tumor

Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=226 | Recruiting | Sponsor: Whitehawk Therapeutics, Inc.

First-in-human • New P1 trial • Platinum resistant • Endometrial Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • EGFR

Whitehawk Therapeutics Advances to Clinical Stage with IND Clearance for HWK-007 and Announces IND Submission for HWK-016 (PRNewswire) - "Whitehawk's Phase 1 trial for HWK-007 is now actively recruiting and will initially evaluate activity in lung and ovarian cancers....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....Whitehawk expects to report initial clinical data from these trials in early 2027."

IND • New P1 trial • P1 data • Endometrial Cancer • Non Small Cell Lung Cancer • Ovarian Cancer

Whitehawk Therapeutics Presents Real-World Analysis Confirming PTK7 as a Broadly Expressed, Clinically Relevant Target Across Solid Tumors at AACR-NCI-EORTC (PRNewswire) - "PTK7 is expressed in ~70% of solid tumors. PTK7 is the third most highly expressed tumor marker among clinically validated and emerging ADC targets, after HER2 and HER3....Findings support potential of PTK7 as a pan-tumor target, reinforcing Whitehawk's development of PTK7-directed ADC HWK-007....The Company plans to submit an Investigational New Drug application to the U.S. Food and Drug Administration for HWK-007 by year-end, with initial clinical evaluation planned in NSCLC, ovarian and endometrial cancers."

IND • Real-world • Endometrial Cancer • Non Small Cell Lung Cancer • Ovarian Cancer

Aadi Bioscience Transforms with In-Licensing of Novel ADC Portfolio… (PRNewswire) - "Aadi Bioscience...announced it has entered into an exclusive license agreement for development and global commercialization of a three-asset portfolio of preclinical, next-wave antibody-drug conjugates (ADCs), in collaboration with WuXi Biologics...and HANGZHOU DAC....Per the terms of the license agreement, Aadi is granted exclusive rights to certain patents and know-how pertaining to three preclinical ADC programs leveraging HANGZHOU DAC's CPT113 linker payload technology targeting each of Protein Tyrosine Kinase 7 (PTK7), Mucin-16 (MUC16) and Seizure Related 6 Homolog (SEZ6). Aadi will pay aggregate upfront payments of $44 million for in-licensing such ADC programs. Additionally, Aadi is obligated to pay cumulative development milestone payments of up to $265 million, cumulative commercial milestone payments of up to $540 million and single-digit royalties of sales."

Licensing / partnership • Solid Tumor