ABP News & Events

Abpro announced, together with its co-development partner Celltrion, that the U.S. Food and Drug Administration, FDA, has cleared the Investigational New Drug, IND, application for ABP-102 / CT-P72, Abpro's lead multispecific antibody oncology program. The IND clearance enables the initiation of a Phase 1 clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABP-102 / CT-P72 in patients with HER2-positive solid tumors. The Phase 1 clinical study will be led by Celltrion as part of the ongoing joint strategic collaboration to ensure the robust progression of the ABP-102 / CT-P72 program.

Abpro Holdings announced the submission of an investigational new drug application to the U.S. Food and Drug Administration for ABP-102/CT-P72, a HER2 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. Abpro Holdings and CELLTRION, INC. recently presented preclinical results for ABP-102/CT-P72 at the American Association for Cancer Research 2025 Annual Meeting and at the Society for Immunotherapy of Cancer 40th Anniversary Annual Meeting, highlighting selective activity in HER2-high tumor models and lower activity on cells with normal-tissue-level HER2 expression in preclinical studies. In non-human primates, ABP-102/CT-P72 was well tolerated. Together, these findings support the potential for a favorable therapeutic index in clinical studies. 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.