Celltrion said on the 29th that it obtained U.S. Food and Drug Administration (FDA) approval of an investigational new drug (IND) application to conduct a phase 1 clinical trial of its multi-antibody-based anticancer drug candidate "CT-P72/ABP-102."
CT-P72/ABP-102 is a multi-antibody immuno-oncology drug candidate that Celltrion is co-developing with Abpro in the United States. It is designed as a "T-cell engager" that links cancer cells expressing HER2 (human epidermal growth factor receptor 2), a protein involved in cell growth, with T cells, a type of immune cell, to eliminate the cancer cells. The drug acts selectively on cancer cells while minimizing unnecessary reactions in normal cells with low HER2 expression.
Celltrion plans to evaluate the candidate's safety, tolerability, and initial efficacy in this trial. Preclinical study results confirming antitumor effects in a mouse (rat) model were released at "SITC2025" (Society for Immunotherapy of Cancer) held in Maryland in the United States on the 11th. Excellent tolerability was observed in normal cells with low HER2 expression, and no notable adverse effects were observed up to a high dose of 80 mg/kg in toxicity studies using nonhuman primates, the company said.
A Celltrion official said, "We plan to begin dosing patients next year," adding, "Based on this IND approval, we will ramp up development of multi-antibody therapeutics and accelerate the expansion of our new drug pipeline."