Abpro and Celltrion Submit IND Application for HER2-Targeting T Cell Engager ABP-102/CT-P72
核心洞察
Abpro Holdings (搜索) and Celltrion have submitted an IND application to the FDA for ABP-102/CT-P72 (搜索), a HER2 (搜索) × CD3 (搜索) T cell engager designed for HER2-positive solid tumors (搜索).
Preclinical studies demonstrated enhanced tumor selectivity in HER2 (搜索)-high models with reduced activity on normal tissue-level HER2 expression, supporting a favorable therapeutic index.
The Phase 1 clinical trial is anticipated to begin in the first half of 2026, evaluating safety, pharmacokinetics, and preliminary efficacy in patients with HER2 (搜索)-positive breast and gastric cancers.
Abpro Holdings (搜索) and Celltrion have submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration for ABP-102/CT-P72 (搜索), a HER2 (搜索) × CD3 (搜索) T cell engager engineered with optimized binding properties to improve tumor selectivity. The submission, announced December 15, 2025, represents a significant milestone for both companies and marks Abpro's first IND submission for a phase 1 trial in a solid tumor indication.
The novel therapeutic candidate is designed to target HER2-positive cancers (搜索), including breast and gastric cancers, with enhanced selectivity for tumor cells expressing high levels of HER2 (搜索) while minimizing activity against cells with normal tissue-level HER2 expression. Pending regulatory clearance, the phase 1 clinical trial is anticipated to begin in the first half of 2026.
Preclinical Data Supports Therapeutic Potential
Recent preclinical results presented at the American Association for Cancer Research (AACR) 2025 Annual Meeting and the Society for Immunotherapy of Cancer (SITC) 40th Anniversary Annual Meeting demonstrated compelling evidence for ABP-102/CT-P72 (搜索)'s therapeutic potential. The studies highlighted selective activity in HER2 (搜索)-high tumor models and lower activity on cells with normal tissue-level HER2 expression.
In non-human primate studies, ABP-102/CT-P72 (搜索) was well tolerated, providing additional support for a favorable therapeutic index in clinical studies. These findings collectively suggest the potential for improved safety and efficacy compared to existing HER2 (搜索)-targeting approaches.
Phase 1 Trial Design and Objectives
Upon FDA authorization to proceed, the planned phase 1 study will evaluate the safety, pharmacokinetics, and preliminary efficacy of ABP-102/CT-P72 (搜索) using a dose-escalation and dose-expansion format. The trial will focus on patients with HER2-positive cancers (搜索), including breast and gastric cancers, with data generated from the study informing dose selection and guiding subsequent clinical development.
"We are pleased to advance ABP-102/CT-P72 (搜索) to IND review; this reflects the strength of our T cell engager platform and the productive collaboration between Abpro and Celltrion throughout development," said Miles Suk, CEO of Abpro. "This milestone brings us closer to delivering a potentially highly selective therapeutic candidate for patients with HER2 (搜索)-positive solid tumors (搜索), including those with limited treatment options."
Strategic Collaboration and Pipeline Advancement
The development of ABP-102/CT-P72 (搜索) represents a collaborative effort between Abpro Holdings (搜索), a Burlington, Massachusetts-based biotechnology company, and Celltrion, Inc., a leading South Korean biopharmaceutical company. This partnership leverages Abpro's proprietary DiversImmune® platform for antibody development and Celltrion's extensive experience in biopharmaceutical manufacturing and development.
For Abpro, this IND submission underscores the momentum across the company's broader T-cell-engager platform as it continues to expand and advance a differentiated oncology pipeline. The company is advancing multiple next-generation antibody therapies for HER2-positive cancers (搜索), non-HER2 (搜索)-positive gastric and liver cancer, and wet age-related macular degeneration and diabetic macular edema.
The submission of ABP-102/CT-P72 (搜索)'s IND application represents a critical step forward in bringing innovative T cell engager technology to patients with HER2 (搜索)-positive solid tumors (搜索), potentially addressing unmet medical needs in this patient population.