SINGAPORE — September 30, 2026
Hummingbird Bioscience announced that the first patient has been dosed in the Phase II portion of the HMBD-001-103 clinical trial, advancing HMBD-001 into Phase II development for patients with advanced squamous cell cancers. HMBD-001 is an investigational anti-HER3 monoclonal antibody developed using Hummingbird’s AI Molecular Medicine (AIMM) platform and Rational Antibody Discovery technology. The company has identified recommended doses for expansion (RDEs) for HMBD-001 in combination with the EGFR inhibitor cetuximab, supported by clinical safety, tolerability and preliminary efficacy findings reported to date. The Phase II study is enrolling patients across China, Australia, Moldova and Singapore, while the program also has an approved U.S. FDA Investigational New Drug application.
HMBD-001 Advances Into Phase II Development
The HMBD-001-103 Phase II program is evaluating the antibody in combination with cetuximab in advanced squamous cell cancers. HMBD-001 was designed to target a functionally important epitope at the HER3 dimerization interface, with the objective of blocking HER3 heterodimerization with EGFR or HER2. According to Hummingbird, this mechanism is intended to inhibit both ligand-dependent and ligand-independent HER3 activation and downstream oncogenic signaling. The identification of RDEs enables the company to expand clinical evaluation of the combination after initial dose-escalation work. Merck KGaA, Darmstadt, Germany, will continue supplying cetuximab under an existing clinical trial collaboration and supply agreement, while each company retains commercial rights to its respective compound.
AI Platform Guides Target and Patient Selection
Hummingbird said its AIMM platform contributed to both HMBD-001 design and the clinical development strategy for the program. Its Rational Antibody Discovery platform identified the HER3 dimerization interface as a targetable epitope and was used to engineer the antibody. The company’s proprietary AI Reasoning Engine (AIRE) was then used to analyze disease biology and identify squamous cell carcinomas as tumor types with potential HER3/EGFR signaling dependency. These analyses supported prioritizing squamous cancers and combining HMBD-001 with cetuximab, while also informing consideration of potential resistance mechanisms. Hummingbird plans to continue applying its AI-enabled approach to patient selection and clinical development as the Phase II program progresses.
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HMBD-001 Program Expands Clinical Development Strategy
The advancement of HMBD-001 provides a clinical-stage application of Hummingbird’s AI-first drug discovery and development model. The company is investigating whether dual pathway inhibition through HER3 and EGFR targeting can provide therapeutic activity in advanced squamous cancers while potentially supporting chemotherapy-free treatment approaches. HMBD-001 remains investigational, and the preliminary efficacy observations reported by the company require confirmation in the ongoing Phase II study. Hummingbird is also advancing additional programs through its AIMM platform, which integrates computational analysis with experimental and translational data to support target selection, therapeutic design and clinical development. The first patient dose in Phase II marks the next stage of clinical evaluation for HMBD-001 and will provide additional data on the safety, tolerability and potential efficacy of the HER3-targeted approach.
Source :Hummingbird Bioscience, press release
