Abpro Holdings, Inc. together with its co-development partner Celltrion, Inc. announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for ABP-102/CT-P72, a HER2 x CD3 T cell engager engineered with optimized CD3 and HER2 binding to improve tumor selectivity. Pending regulatory clearance, this IND will support the initiation of a phase 1 clinical trial, anticipated to begin in 1H 2026 in patients with HER2-positive cancers including breast and gastric cancers. This submission represents a significant milestone in the companies' collaborative development of ABP- 102/CT-P72 and marks an important advance for Abpro's broader immuno-oncology pipeline.
Upon FDA authorization to proceed, the planned phase 1 study will evaluate the safety, pharmacokinetics, and preliminary efficacy of ABP-102/CT-P72 in a dose-escalation and dose-expansion format. Data generated from the trial will inform dose selection and guide subsequent clinical development.
