Abpro and Celltrion, Inc. Announce U.S. FDA IND Clearance for Lead Multispecific Antibody Cancer Candidate ABP-102 / CT-P72

Core Insights - The FDA has cleared Abpro's Investigational New Drug (IND) application for ABP-102 / CT-P72, enabling the initiation of the first clinical-stage solid tumor program [1][2] - The Phase 1 clinical trial is set to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABP-102 / CT-P72 in patients with HER2-positive solid tumors, with Celltrion leading the study [2][7] Group 1: Clinical Development - The Phase 1 clinical trial is anticipated to commence in the first half of 2026, following final site activation and regulatory processes [7] - The study will include dose-escalation and dose-expansion cohorts to inform future clinical development strategies [7] Group 2: Product Details - ABP-102 / CT-P72 is a multispecific HER2 × CD3 T-cell engager designed to selectively target HER2-overexpressing tumor cells while engaging cytotoxic T cells, aiming to enhance tumor selectivity and limit activity in normal HER2-low tissues [3][4] - Preclinical studies demonstrated robust antitumor activity in HER2-high tumor models, with selective efficacy for HER2-high tumors [4][6] Group 3: Safety and Efficacy - The optimized CD3 binding of ABP-102 / CT-P72 is intended to mitigate excessive immune activation and reduce the risk of cytokine release syndrome, with non-human primate studies showing it was well tolerated at doses up to 80 mg/kg [5] - Additional preclinical evaluations indicated activity in tumor models representing resistance to existing HER2-directed therapies, highlighting its potential to address unmet medical needs [6] Group 4: Company Background - Abpro is focused on developing next-generation antibody therapies for severe diseases, including HER2+ cancers and other conditions, utilizing its proprietary DiversImmune® platform [8] - Celltrion, based in South Korea, specializes in developing innovative therapeutics and aims to improve patient access to reliable healthcare [11]