BigHat Biosciences has given the first dose of BHB810, an antibody‑drug conjugate aimed at gastric cancer and other advanced gastrointestinal malignancies. The treatment marks a notable milestone for the biotech firm, as it moves its AI‑designed candidate into human clinical trials for the first time. BHB810 targets Cadherin‑17, a protein often found in advanced gastric and gastroesophageal tumors.
Targeting a Difficult Disease
Gastric cancer remains a major global health challenge, frequently diagnosed at advanced stages where treatment options are limited. CDH17, the target of BHB810, has historically been considered a hard target for drug developers because it appears in healthy tissues and binding is complex. BigHat used its proprietary AI platform to create a VHH‑Fc antibody‑drug conjugate structure. This design merges a specialized antibody with a cytotoxic payload that kills cancer cells.
The Phase I study will first evaluate safety, tolerability, and how the body processes the drug, known as pharmacokinetics. The trial will focus on patients with advanced gastric and gastroesophageal tumors that show CDH17 expression. Primary goals are to determine the safety profile and early anti‑tumour activity of BHB810 in humans.
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Preclinical Results and Safety
Before reaching human trials, BHB810 was tested in nearly 30 patient‑derived and cell‑derived tumor models. Researchers included models with low and heterogeneous CDH17 expression, reflecting a difficult clinical scenario to replicate in the lab. Despite this complexity, BHB810 induced complete or near‑complete tumor clearance in these preclinical settings.
Results were impressive.
The drug’s compact antibody structure and stable payload technology also contributed to a promising safety profile observed in animal studies.
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Moving from controlled preclinical environments to actual patients brings many challenges, especially for a disease where drug resistance can emerge quickly. If BHB810 preserves the favorable safety profile seen in animals while effectively targeting tumors with varying CDH17 levels, it could prove that the AI platform can accurately predict clinical outcomes. Early trial success would confirm the firm’s approach to identifying and developing promising antibodies for clinic‑ready therapeutics.
Expanding the Pipeline
Peyton Greenside, co‑founder and CEO of BigHat, commented on the progress. “Treating the first patient with BHB810 marks an important step forward in our mission to enable transformative AI‑designed therapeutics,” Greenside said. “This is the first programme we’ve taken from AI‑generated design into human studies, validating the ability of our platform to identify and develop promising antibodies for clinical use.”
Alongside BHB810, the firm is developing other investigational therapies. BHB299, a T‑cell engager targeting CEACAM6 in solid tumours, is slated to enter clinical studies in 2027. The company has also partnered with major pharmaceutical players, including Johnson & Johnson and Merck. In April 2025, Eli Lilly signed a new research agreement with BigHat to co‑develop next‑generation antibody therapeutics, as the firm continues to grow its capabilities in AI‑driven drug development.