Note:This article does not constitute any investment opinions or suggestions; please refer to official/company announcements for accuracy.This article is only for the introduction of medical and health-related drugs, not a recommendation of treatment options (if involved), and does not represent the platform's position.Any article reprinted needs to be authorized.
On December 29, Celltrion announced that CT-P72/ABP-102, a bispecific antibody drug for HER2-positive solid tumors jointly developed with U.S.-based Abpro Corporation, has received approval from the U.S. Food and Drug Administration (FDA) and will soon commence Phase I clinical trials.ABP-102 is a bispecific T-cell engager targeting HER2 and CD3, designed with a tetravalent IgG1-[L]-single-chain variable fragment (scFv) configuration. The molecule aims to selectively eliminate HER2-overexpressing tumor cells and effectively reduce non-specific toxicity to normal tissues with low HER2 expression by lowering the affinity of the HER2-binding arm. According to a company statement, after completing the necessary preparations, patient dosing is planned to begin next year.Preclinical studies presented in November at the Society for Immunotherapy of Cancer annual meeting showed that the drug inhibited tumors in both HER2 high- and low-expressing mouse models and was tolerated at doses up to 80 mg/kg in primate toxicity tests.A relevant official from Celltrion stated, "CT-P72/ABP-102 is a multispecific antibody candidate drug that has demonstrated the potential to enhance the therapeutic index during the preclinical stage through the optimization of antibody binding sites."This approval marks the second regulatory milestone recently achieved by Celltrion's innovative drug pipeline, following the FDA Fast Track designation granted to the antibody-drug conjugate CT-P70. The company plans to expand its innovative drug pipeline to 20 candidate drugs by 2027, with 10 of them entering clinical stages, to reduce reliance on biosimilars.Reference: Company Announcement
Copyright statement: This article is reproduced from the BioDrug Era, Media or individuals who do not wish to be reprinted can contact us, and we will delete it immediately.
