Abpro Achieves U.S. FDA IND Clearance for Key Multispecific Antibody Program ABP-102 / CT-P72
BURLINGTON, Mass. and INCHEON, South Korea, January 6, 2026 — Abpro Holdings, Inc. (Nasdaq: ABP) has announced the U.S. Food and Drug Administration (FDA) has granted clearance for its Investigational New Drug (IND) application for ABP-102 / CT-P72. This marks the official initiation of Abpro’s first clinical-stage program focusing on solid tumors, a significant milestone for the biotechnology company and its partner, Celltrion, Inc.
Clinical Trial Details
The IND approval allows for the launch of a Phase 1 clinical trial, which will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABP-102 / CT-P72 in patients diagnosed with HER2-positive solid tumors. The trial is set to commence in the first half of 2026, under the leadership of Celltrion, as part of their collaborative efforts to advance this promising program.
Statements from Leadership
“This IND clearance marks an important step for Abpro as we advance our lead solid tumor program into clinical evaluation,” stated 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, emphasized, “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.”
About ABP-102 / CT-P72
ABP-102 / CT-P72 is a multispecific HER2 × CD3 T-cell engager designed to selectively target HER2-overexpressing tumor cells while simultaneously engaging cytotoxic T cells. The engineering of this candidate focuses on enhancing tumor selectivity while minimizing activity in normal HER2-low tissues, a critical aspect in addressing safety concerns related to T-cell engagers in solid tumors.
Preclinical Study Findings
- Demonstrated strong antitumor activity in HER2-high tumor models.
- Showed selective efficacy in dual xenograft models involving both HER2-high and HER2-low tumors.
- Well-tolerated in non-human primate toxicology studies at dosages up to 80 mg/kg, with no significant adverse effects.
These findings highlight the potential of ABP-102 / CT-P72 to overcome resistance in existing HER2-directed therapies, aiming to fill unmet medical needs in oncology.
Next Steps in Clinical Development
With the IND cleared, Abpro and Celltrion intend to initiate the global Phase 1 clinical trial in early 2026, pending final site activation and regulatory approvals. The study will incorporate both dose-escalation and dose-expansion cohorts, crucial for informing future development strategies for ABP-102 / CT-P72.
About Abpro
Abpro is dedicated to enhancing the lives of patients facing severe diseases through innovative antibody therapies developed with its proprietary DiversImmune® platform. The company is working on a pipeline that includes therapies for HER2-positive cancers as well as other critical conditions like gastric and liver cancers.
About Celltrion
Celltrion, based in Incheon, South Korea, is a prominent biopharmaceutical company focused on developing innovative therapeutics to improve global health outcomes. Its commitment to sustainability and ethical practices underpins its mission to expand access to reliable healthcare solutions worldwide.
Forward-Looking Statements
This article contains forward-looking statements regarding the future of Abpro's clinical development and strategic partnerships. Actual results may vary due to numerous factors, including regulatory approval processes and market conditions.