At the AACR 2025 Annual Meeting, Yuhan Corporation presented encouraging interim results from a Phase 1 trial of YH32367, a bispecific antibody targeting HER2 and 4-1BB, in patients with HER2-positive solid tumors refractory or resistant to trastuzumab (Herceptin).
The study showed an objective response rate (ORR) of 22.6% and a disease control rate (DCR) of 55% among 32 patients, including those with cholangiocarcinoma and gastric cancer. Notably, the cholangiocarcinoma subgroup achieved an ORR of 31% and DCR of 62%, with no dose-limiting toxicity (DLT) observed across all eight dose levels (0.3-30 mg/kg).
YH32367, co-developed with Korea-based ABL Bio (development code: ABL105), is engineered to locally activate 4-1BB in HER2-positive tumors while minimizing off-target toxicity. The candidate showed a favorable safety profile, with the most common adverse events being fever (16%) and chills (13%). One death occurred in the 0.75 mg/kg cohort but was not attributed to the drug.
Yuhan concluded that the compound demonstrated promising early antitumor activity, manageable safety, and a non-linear pharmacokinetic (PK) profile, supporting continued development and dose optimization efforts.
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