HWK-206 / Whitehawk Therapeutics, Hangzhou DAC Biotech, WuXi AppTec - LARVOL DELTA

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-206, a next-generation, biparatopic, SEZ6-targeting ADC with novel bioconjugation and linker-payload technology (AACR 2026) - "Single-epitope, SEZ6-directed antibody-drug conjugates (ADCs), such as ABBV-706, have shown initial promise in SCLC and NE neoplasms, but with some potential challenges attributed to side effects associated with these agents. In summary, HWK-206 is a highly potent and selective next-generation, biparatopic, SEZ6-targeted ADC that warrants further investigation. A planned phase I dose-escalation study will investigate HWK-206 in patients with advanced solid tumors."

ADC • Preclinical • Bladder Cancer • Brain Cancer • CNS Tumor • Lung Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • SEZ6

Preclinical assessment of HWK-206, a next-generation, biparatopic, SEZ6-targeting ADC with novel bioconjugation and linker-payload technology (Poster #4440) (PRNewswire) - "Whitehawk Therapeutics presents comprehensive preclinical data highlighting its next-generation ADC portfolio at the AACR 2026....Key preclinical findings include: Increased binding and internalization compared with a parental monoclonal antibody alone, and compared with clinical-stage ADC, ABBV-706; Greater inhibition of cell viability compared with ABBV-706 in cell lines with varying SEZ6 expression; Produces tumor regressions at doses as low as 2 mg/kg in small cell lung cancer models....An IND submission for HWK-206 is on track for mid-2026."

IND • Preclinical • Lung Neuroendocrine Carcinoma • 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

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