Adcoris' Investigational New Drug Application for ACR246 as an Injectable Antibody-drug Conjugate for Solid Tumors Accepted by NMPA
2023-11-23 Source:   Browse:2329
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On November 22, 2023, an investigational new drug (IND) application for ACR246 by Adcoris was accepted by China National Medical Products Administration (NMPA). ACR246 is an injectable antibody-drug conjugate (ADC) that targets tumor associated antigen, 5T4, which is highly expressed in a variety of solid tumors and has a wide range of clinical indications. ACR246 is Adcoris’ first in-house developed ADC and potentially the best in class (BIC) ADC against 5T4 tumor cell antigen. The successful submission and acceptance of its IND application marks a new milestone for the company’s drug research and development program.

The IND application includes experimental data, official reports and overview summaries of numerous studies to evaluate the pharmacology, pharmacokinetics, and toxicology of ACR246 both in vitro and in vivo, including various cancer cell lines and tumor CDX models. In addition, the application describes the manufacture of the drug substance and drug product to be used in human clinical trials. The main purpose of the IND is to share with the NMPA the extensive non-clinical data to support an acceptable safety profile when ACR246 will be first administered to humans. 

About ACR246
ACR246 is a potentially BIC that targets 5T4 with a novel TOP1 inhibitor as its payload and a stable and tumor microenvironment (TME) cleavable linker. 5T4 is an oncofetal antigen (also known as trophoblast glycoprotein, TPBG) that has high expression in many solid tumors, but no or limited expression in normal adult tissues. Therefore, ACR246 may have broad therapeutic benefits in a wide range of solid tumors. The preclinical studies demonstrated that ACR246 was highly potent and significantly superior to Dxd-ADC in more than 10 tumor CDX models tested. ACR246 has the potential to treat multiple solid tumors and is expected to initiate first in human clinical study in the first quarter of 2024.