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

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

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

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