On December 29, Celltrion announced that its bispecific antibody drug CT-P72/ABP-102, co-developed with US-based Abpro Corporation for the treatment of HER2-positive solid tumors, has obtained approval from the U.S. Food and Drug Administration (FDA) and is set to initiate a Phase I clinical trial.
ABP-102 is a bispecific T-cell engager (BiTE) targeting HER2 and CD3, engineered with a tetravalent IgG1-[L]-single-chain variable fragment (scFv) format. This molecule is designed to selectively eliminate tumor cells with high HER2 expression, and by reducing the affinity of its HER2-binding arm, it effectively mitigates off-target toxicities to normal tissues with low HER2 expression. In a corporate statement, Celltrion noted that it plans to start administering the drug to patients in the next year upon completion of relevant preparatory work.
Preclinical research data presented at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in November demonstrated that the drug inhibited tumor growth in both HER2-high and HER2-low expressing mouse models, and exhibited tolerability in non-human primate toxicity studies at doses up to 80 mg/kg.
A senior executive of Celltrion commented: "CT-P72/ABP-102 is a multispecific antibody candidate, and its optimized antibody binding sites have demonstrated the potential to improve the therapeutic index during the preclinical phase."
This FDA approval marks the second regulatory milestone recently achieved for Celltrion’s innovative drug pipeline, following the FDA’s fast track designation granted to its antibody-drug conjugate (ADC) CT-P70. Celltrion aims to expand its innovative drug pipeline to 20 drug candidates by 2027, 10 of which are expected to advance to clinical stages, in a bid to reduce its reliance on biosimilars.