Celltrion Receives FDA IND Approval for Phase 1 Trial of Multi-Antibody Drug 'CT-P72'

New Anticancer Drug Based on HER2-Targeted T-Cell Engager

Celltrion announced on December 29 that it has received approval from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application to proceed with a Phase 1 clinical trial of its multi-antibody-based anticancer drug candidate, CT-P72/ABP-102.

Celltrion

CT-P72/ABP-102 is a multi-antibody immuno-oncology drug currently being co-developed by Celltrion and Abpro in the United States. It is designed as a T-cell engager (TCE) that connects cancer cells expressing the HER2 (human epidermal growth factor receptor 2) protein, which is involved in cell growth, with immune T cells to eliminate cancer cells. A T-cell engager is a bispecific antibody engineered to simultaneously recognize both tumor cells and T cells. It directly binds T cells to tumor cells, inducing an immune response that destroys the cancer cells, thus serving as an immuno-oncology therapeutic mechanism.

Prior to this IND approval, Celltrion presented the preclinical study results of CT-P72/ABP-102 last month at the SITC 2025 (Society for Immunotherapy of Cancer) conference held in Maryland, USA.

In the preclinical studies, the antitumor effect against HER2 high-expression tumors was confirmed in a mouse model implanted with both high and low HER2-expressing cell lines. During the preclinical evaluation, excellent tolerability was also observed in normal cells with low HER2 expression. Toxicity tests in primates confirmed overall safety, as no significant side effects were observed even at high doses of up to 80 mg/kg.

These results reflect the structural design features of CT-P72/ABP-102. The drug is engineered to selectively target cancer cells with high HER2 expression while minimizing unnecessary reactions in normal cells with low HER2 expression. The binding affinity to CD3, which activates T cells, is also controlled to suppress excessive immune responses and minimize the risk of cytokine release syndrome.

Through this design, the therapeutic index (TI)-the range between effective and toxic doses-was found to be significantly expanded at the preclinical stage compared to other HER2-targeted TCE therapies.

With this IND approval, Celltrion plans to initiate a global Phase 1 clinical trial to evaluate the safety, tolerability, and initial efficacy of CT-P72/ABP-102. Following the IND approval, the company will complete clinical preparations and aims to begin patient dosing next year.

A Celltrion representative stated, "CT-P72/ABP-102 is a multi-antibody anticancer drug candidate that demonstrated the potential to improve the therapeutic index by controlling antibody binding affinity at the preclinical stage. Based on this IND approval, we plan to accelerate the development of multi-antibody therapeutics and expand our new drug pipeline."