1. ABP-102/CT-P72 IND submission could advance oncology treatment options. 2. Preclinical results show selective activity in HER2-high tumors. 3. Phase 1 trial expected to start in 1H 2026, pending FDA approval. 4. Collaboration with Celltrion highlights potential market strength. 5. Favorable safety profile observed in non-human primate studies.
FAQ
Why Bullish?
Successful IND submission is pivotal for ABP, akin to other biotech breakthroughs significantly boosting stock prices when trials progress positively.
How important is it?
The IND application is a major milestone in Abpro's journey, which can draw investor interest and affect stock performance significantly.
Why Long Term?
The Phase 1 trial could lead to valuable long-term insights, influencing market perception of ABP's future capabilities.
Abpro Holdings Submits IND Application for Phase 1 Clinical Trial of ABP-102/CT-P72
Burlington, MA, December 15, 2025 – Abpro Holdings, Inc. (Nasdaq: ABP), a leading biotechnology company specializing in innovative therapeutics for solid tumors, announced today the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA). This application is for ABP-102/CT-P72, a HER2 × CD3 T cell engager designed to enhance tumor selectivity and improve safety profiles for patients suffering from HER2-positive cancers.
Significance of the IND Submission
The submission of the IND for ABP-102/CT-P72 marks a pivotal point for Abpro as it represents the company's first submission for a Phase 1 trial targeting solid tumors. If granted regulatory approval, the clinical trial is expected to start in the first half of 2026. This trial will focus on evaluating patients with HER2-positive breast and gastric cancers, further advancing Abpro's significant immuno-oncology pipeline.
Preclinical Results Highlight Efficacy
Recent presentations at both the American Association for Cancer Research (AACR) 2025 Annual Meeting and the Society for Immunotherapy of Cancer (SITC) 40th Anniversary Annual Meeting showcased compelling preclinical data. Highlights include:
- Enhanced HER2-High Tumor Selectivity: ABP-102/CT-P72 demonstrated selective activity in HER2-high tumor models.
- Lower Activity in Normal Tissues: The compound showed reduced activity on cells with normal tissue-level HER2 expression.
- Tolerability: In non-human primates, ABP-102/CT-P72 was well tolerated, indicating a favorable therapeutic index.
CEO Statements on Development
“We are pleased to advance ABP-102/CT-P72 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. He emphasized that this milestone draws them closer to providing a highly selective therapeutic option for patients with HER2-positive solid tumors, particularly for those with limited treatment alternatives.
Upcoming Phase 1 Study Details
Pending FDA authorization, the planned Phase 1 clinical trial will assess:
- The safety and pharmacokinetics of ABP-102/CT-P72.
- Preliminary efficacy through a dose-escalation and dose-expansion format.
The trial’s findings will guide dose selection and inform subsequent clinical development efforts.
About Abpro Holdings
Abpro is dedicated to advancing antibody therapies for severe and life-threatening diseases. Its diverse pipeline targets various conditions, including HER2-positive cancers and wet age-related macular degeneration. Utilizing the proprietary DiversImmune® platform, Abpro continues to develop next-generation antibody therapies that promise to revolutionize treatment methods.
Forward-Looking Statements
This announcement contains forward-looking statements regarding Abpro's future business and financial performance. Key phrases such as “may,” “will,” “could,” and “expect” identify these statements, which reflect management’s current beliefs and anticipate future events. Investors are cautioned not to place undue reliance on these forward-looking statements.
About Celltrion
Celltrion, based in Incheon, South Korea, is a leading biopharmaceutical company focused on developing innovative therapeutics. With a commitment to sustainable growth and ethical practices, Celltrion works towards enhancing patient access to reliable healthcare solutions.