Abpro and Celltrion to Start Global Trial of Targeted HER2+ Cancer Antibody in Early 2026

Abpro Holdings, Inc. (NASDAQ:ABP), a biotechnology company developing next-generation antibody therapeutics for solid tumors, today announced, together with its co-development partner Celltrion, Inc., 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.

"This IND clearance marks an important step for Abpro as we advance our lead solid tumor program into clinical evaluation," said Miles Suk, CEO of Abpro. "ABP-102 / CT-P72 represents our first clinical-stage T-cell engager program in oncology, and we believe its differentiated design has the potential to translate into a meaningful therapeutic profile for patients with HER2-positive cancers."

Soo Young Lee, Executive Vice President and Head of New Drug Division at Celltrion, Inc. added, "Based on preclinical data generated to date, we see meaningful potential in ABP-102 / CT-P72 as a next-generation HER2-targeted T-cell engager. We are pleased to support its clinical advancement and to continue working closely with Abpro as the program moves into Phase 1 development."

ABP-102 / CT-P72 is a multispecific HER2 × CD3 T-cell engager engineered to selectively target HER2-overexpressing tumor cells while engaging cytotoxic T cells, with optimized binding designed to enhance tumor selectivity and limit activity in normal HER2-low tissues. This design is intended to direct immune activity toward cancer cells while seeking to minimize damage to healthy tissue, addressing a key safety challenge that has limited the use of T-cell engagers in solid tumors.

In preclinical studies, ABP-102 / CT-P72 demonstrated robust antitumor activity in HER2-high tumor models, including dual xenograft models containing both HER2-high and HER2-low tumors, with selective efficacy for HER2-high tumors.

The optimized CD3 binding of ABP-102 / CT-P72, functionally linked with HER2-high selectivity, is intended to mitigate excessive immune activation and reduce the risk of cytokine release syndrome.  Non-human primate toxicology studies showed the candidate was well tolerated at doses up to 80 mg/kg, with no significant adverse effects observed, supporting a differentiated therapeutic index.

Additional preclinical evaluations demonstrated activity in tumor models representing resistance to existing HER2-directed therapies, highlighting the potential to address areas of unmet medical need. Preclinical data sets for ABP-102 / CT-P72 have been presented at major scientific meetings, including the 2025 Annual Meeting of the American Association for Cancer Research and the 2025 Annual Meeting of the Society for Immunotherapy of Cancer.

Following IND clearance, Abpro and Celltrion plan to initiate a global Phase 1 clinical trial in the first half of 2026, subject to final site activation and regulatory processes. The study is expected to include dose-escalation and dose-expansion cohorts and will inform future clinical development strategies.