Abpro (ABP) FDA Approvals

Abpro's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Abpro (ABP). Over the past two years, Abpro has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ABP-102. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

ABP-102 FDA Regulatory Timeline and Events

ABP-102 is a drug developed by Abpro for the following indication: To optimize tumor selectivity and reduce cytokine-related toxicity. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

FDA Clearance - January 6,2026

• Drug: ABP-102
• Announced Date: January 6, 2026
• Indication: To optimize tumor selectivity and reduce cytokine-related toxicity.

Abpro Holdings, Inc. announced, together with its co-development partner Celltrion, Inc., that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for ABP-102 / CT-P72, Abpro's lead multispecific antibody oncology program.

Abpro Holdings, together with co-developer Celltrion, announced that the U.S. Food and Drug Administration has cleared the Investigational New Drug (IND) application for ABP-102 / CT-P72, Abpro’s lead multispecific antibody oncology program. The clearance enables the start of a Phase 1 clinical trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy in patients with HER2‑positive solid tumors. The global study, led by Celltrion under the companies’ collaboration, is expected to begin in the first half of 2026.

ABP-102 / CT-P72 is a multispecific HER2 × CD3 T‑cell engager engineered to selectively target HER2‑overexpressing cancer cells while engaging cytotoxic T cells. Its optimized binding aims to increase tumor selectivity, limit activity in HER2‑low normal tissues and reduce the risk of excessive immune activation such as cytokine release syndrome.

In preclinical work, ABP-102 / CT-P72 showed strong antitumor activity in HER2‑high models and was well tolerated in non‑human primates at doses up to 80 mg/kg. The planned Phase 1 will include dose‑escalation and expansion cohorts to guide further development.

IND Submission - December 15,2025

IND

• Drug: ABP-102
• Announced Date: December 15, 2025
• Indication: To optimize tumor selectivity and reduce cytokine-related toxicity.

Abpro Holdings, Inc. announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) 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.

Abpro Holdings and Celltrion submitted an investigational new drug (IND) 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 enhance tumor selectivity. If cleared, the IND will enable a phase 1 dose‑escalation and dose‑expansion trial expected to start in 1H 2026 in patients with HER2‑positive cancers, including breast and gastric cancers. The study will evaluate safety, pharmacokinetics and early signs of activity to guide dose selection and further development.

Preclinical data presented at AACR and SITC showed selective activity against HER2‑high tumor models and reduced activity on cells with normal tissue levels of HER2. In non‑human primates, ABP‑102/CT‑P72 was well tolerated, suggesting a potentially favorable therapeutic index. This IND marks Abpro’s first submission for a solid tumor T‑cell engager and advances the companies’ collaborative immuno‑oncology program.

Clinical Data - April 27,2025

• Drug: ABP-102
• Announced Date: April 27, 2025
• Indication: To optimize tumor selectivity and reduce cytokine-related toxicity.

Abpro Holdings, Inc. today unveiled preclinical data for ABP-102/CT-P72 in an oral presentation at the American Association for Cancer Research® (AACR) Annual Meeting 2025, in the New Drugs on the Horizon session.

At the AACR Annual Meeting 2025, Abpro Holdings, Inc. presented preclinical data for its investigational drug ABP-102/CT-P72 during the New Drugs on the Horizon session. This tetravalent bispecific T-cell engager is designed to target HER2-overexpressing tumors while reducing harmful effects on normal tissues. Working in partnership with Celltrion, Abpro is focused on addressing HER2-positive cancers, which include significant forms of breast, gastric, and other cancers.

The preclinical findings indicate that ABP-102/CT-P72 may offer superior tumor selectivity, potent efficacy, and an improved safety profile compared to existing therapies. The data also show reduced cytokine release, suggesting that the drug could minimize toxicity issues seen with earlier HER2-targeted treatments. These promising results set the stage for the upcoming clinical trials aimed at providing a safer, more effective option for patients with HER2-driven cancers.

Oral presentation - March 25,2025

• Drug: ABP-102
• Announced Date: March 25, 2025
• Indication: To optimize tumor selectivity and reduce cytokine-related toxicity.

Abpro Holdings, Inc. announced an oral presentation of preclinical data for ABP-102/CT-P72 at the American Association for Cancer ResearchⓇ Annual Meeting 2025 ("AACR 2025") in the New Drugs on the Horizon session. AACR 2025 is taking place April 25-30, at the McCormick Place Convention Center in Chicago.

Abpro Holdings, Inc. announced that it will present preclinical data for its investigational treatment ABP-102/CT-P72 at the AACR 2025 Annual Meeting in Chicago. The company’s oral presentation is scheduled for Sunday, April 27, 2025, from 1:00 to 2:30 pm during the "New Drugs on the Horizon" session. The event is set to take place at the McCormick Place Convention Center.

The presentation will focus on ABP-102/CT-P72, a novel HER2 x CD3 bispecific T-cell engager designed using Abpro’s DiversImmune® platform. This therapeutic is engineered to selectively target tumor cells with high levels of HER2 while reducing activity in cells with normal HER2 expression, potentially lowering cytokine-related toxicity. Led by Dr. Adam J. Pelzek, the preclinical data aims to highlight the treatment's promise against HER2-positive cancers.