Abpro Holdings Submits IND for ABP-102/CT-P72
Abpro Holdings announced the submission of an investigational new drug application to the U.S. Food and Drug Administration for ABP-102/CT-P72, a HER2 CD3 T cell engager engineered with optimized CD3 and HER2 binding to improve tumor selectivity. Pending regulatory clearance, this IND will support the initiation of a phase 1 clinical trial, anticipated to begin in 1H 2026 in patients with HER2-positive cancers including breast and gastric cancers. This submission represents a significant milestone in the companies' collaborative development of ABP-102/CT-P72 and marks an important advance for Abpro's broader immuno-oncology pipeline. Abpro Holdings and CELLTRION, INC. recently presented preclinical results for ABP-102/CT-P72 at the American Association for Cancer Research 2025 Annual Meeting and at the Society for Immunotherapy of Cancer 40th Anniversary Annual Meeting, highlighting selective activity in HER2-high tumor models and lower activity on cells with normal-tissue-level HER2 expression in preclinical studies. In non-human primates, ABP-102/CT-P72 was well tolerated. Together, these findings support the potential for a favorable therapeutic index in clinical studies. Upon FDA authorization to proceed, the planned phase 1 study will evaluate the safety, pharmacokinetics, and preliminary efficacy of ABP-102/CT-P72 in a dose-escalation and dose-expansion format. Data generated from the trial will inform dose selection and guide subsequent clinical development.
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- Clinical Trial Launch: Abpro, in collaboration with Celltrion, has submitted an IND application for ABP-102/CT-P72, with a phase 1 clinical trial anticipated to begin in 1H 2026 for patients with HER2-positive cancers, marking a significant advancement in the company's immuno-oncology efforts.
- Safety and Selectivity: Preclinical studies demonstrate that ABP-102/CT-P72 exhibits selective activity in HER2-high tumor models and shows good tolerability in non-human primates, indicating its potential advantages in clinical applications.
- Milestone in Collaboration: The submission of this IND application reflects the productive partnership between Abpro and Celltrion, further advancing Abpro's overall progress in the immuno-oncology pipeline and enhancing its competitive position in the market.
- Future Growth Potential: The successful advancement of this project not only addresses the treatment needs of HER2-positive tumor patients but also may provide new growth opportunities for Abpro's antibody therapy pipeline, elevating the company's standing in the biotechnology sector.

- Clinical Trial Milestone: Abpro, in collaboration with Celltrion, has submitted an IND application for ABP-102/CT-P72, marking its first phase 1 trial in solid tumors, anticipated to commence in 1H 2026, aimed at providing new treatment options for HER2-positive cancer patients.
- Safety and Selectivity: Preclinical studies demonstrate that ABP-102/CT-P72 exhibits selective activity in HER2-high tumor models and was well tolerated in non-human primates, indicating a potentially favorable therapeutic index in clinical studies.
- Collaborative Development Advantage: This IND submission reflects the productive collaboration between Abpro and Celltrion, further advancing Abpro's immuno-oncology pipeline and enhancing its competitive position in the market.
- Future Growth Potential: The development of ABP-102/CT-P72 not only offers hope for HER2-positive tumor patients but may also drive long-term growth for Abpro in the oncology treatment sector through its unique therapeutic mechanism.
- Compliance Plan Extension: Abpro has received formal notification from the Nasdaq Hearings Panel granting an extension to allow additional time for compliance, indicating the company's commitment to stabilize its business and build lasting momentum.
- Capital Strategy Optimization: The company has access to up to $44 million in equity financing to support operations and achieve long-term financial goals, enhancing stockholders' equity to maintain listing compliance.
- Significant Cost Optimization: By streamlining its structure, Abpro has achieved an estimated 60% reduction in operating expenses, improving financial health and laying a foundation for future growth.
- Pipeline Progress: Abpro's lead antibody candidate, ABP-102, is on track for first-in-human trials in 2026, showcasing the company's innovative potential and competitive edge in the biotechnology sector.








