HWK-016 / Whitehawk Therapeutics, Hangzhou DAC Biotech, WuXi AppTec - LARVOL DELTA

HIGH MUC16 EXPRESSION IS ASSOCIATED WITH POOR REAL-WORLD OVERALL SURVIVAL IN PATIENTS WITH HIGH-GRADE SEROUS OVARIAN CARCINOMA (IGCS 2026) - P1 | "Across 254 patients, median rwOS was significantly shorter with high (≥9.24) versus low (70 vs ≤70 U/mL) CA125 in patients starting 1L (n=302; log -rank P=0.0104) or 2L+ (n=223; log - rank P=0.00038; Figure 2) treatment."

Clinical • Real-world • Real-world evidence • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • BRCA • HRD • MUC16

A phase I study of HWK-016, a next-generation, mucin 16 (MUC16)-directed antibody-drug conjugate (ADC), in patients with advanced solid tumors (ESMO-Gynae 2026) - P1 | "Trial Design This multicenter, open label, single arm, phase I dose-escalation/expansion study (NCT07470853) assesses HWK-016 as monotherapy (Part A) and in combination with bevacizumab (Part B). Secondary endpoints include pharmacokinetics and preliminary efficacy outcomes. Planned enrollment is up to 265 patients; recruitment is ongoing."

ADC • Clinical • First-in-human • Metastases • P1 data • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • MUC16

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-016, a next-generation, MUC16-targeting ADC with novel bioconjugation and linker-payload technology (AACR 2026) - "Early clinical trials of MUC16-targeted ADCs, DMUC5754A and DMUC4064A, showed promising efficacy but were limited by targeting an epitope within the shed extracellular domain (ECD) of MUC16, leading to off-target binding to circulating CA125, which created an antigen sink. In summary, HWK-016 is a highly potent, MUC16-targeted ADC directed to the MUC16 non-shed ECD to avoid circulating CA125 binding. A phase I dose-escalation study is planned to evaluate HWK-016 in patients with advanced malignant solid tumors."

ADC • IO biomarker • Preclinical • Lung Cancer • Oncology • Solid Tumor • MUC16 • MUC4

HWK-016 is currently being evaluated in a Phase 1 clinical trial in patients with advanced ovarian and endometrial cancers [NCT07470853]. (PRNewswire) - "Initial clinical data are expected in the first half of 2027."

P1 data • Platinum resistant • Endometrial Cancer • Ovarian Cancer

Preclinical assessment of HWK-016, a next-generation, MUC16-targeting ADC with novel bioconjugation and linker-payload technology: (Minisymposium Oral Presentation #1324) (PRNewswire) - "Whitehawk Therapeutics presents comprehensive preclinical data highlighting its next-generation ADC portfolio at the AACR 2026....Key preclinical findings include: Selectively binds membrane‑bound MUC16 to ensure delivery to the tumor instead of circulating CA125; Demonstrates potent binding, internalization and tumor cell-killing, and is minimally impacted by exogenous CA125; Exhibits bystander activity, and produces tumor regressions at doses as low as 1 mg/kg in ovarian cancer xenograft models that shed high levels of CA125."

Preclinical • Ovarian Cancer

Whitehawk Therapeutics Presents Real-World Analysis Confirming MUC16 as a Highly Expressed, Clinically Relevant Target for Gynecologic Cancers at SGO 2026 (PRNewswire) - "MUC16 has high, tumor‑selective expression, with concordance between MUC16 mRNA expression and MUC16 protein abundance by IHC; MUC16 is highly expressed across most histologic subtypes, including the most common subtype, high-grade serous ovarian carcinoma (HGSOC), which accounts for ~70% of cases; MUC16 has high, tumor‑selective expression, with concordance with MUC16 protein abundance by IHC; MUC16 is most highly expressed in serous adenocarcinoma (the most aggressive subtype accounting for ~40% of deaths), followed by endometrioid adenocarcinoma (the most common subtype, accounting for ~90% of cases)."

Real-world • Endometrial Cancer • Ovarian 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

A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors. (clinicaltrials.gov) - P1 | N=265 | Recruiting | Sponsor: Whitehawk Therapeutics, Inc.

First-in-human • New P1 trial • Platinum resistant • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor

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

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