Innovent Biologics, Inc. (HKG: 1801), based in China, has entered into a clinical trial collaboration and supply agreement with Xuanzhu Biopharma to explore the combination therapy of Tyvyt (sintilimab) with KM-501, a novel HER-2 bispecific antibody drug conjugate (ADC). This partnership aims to develop potential treatment options for advanced solid tumors in China.
As part of the agreement, Innovent will supply sintilimab for the collaborative clinical trial, while Xuanzhu Biopharma will initiate a Phase Ib study to assess the anti-tumor efficacy and safety of the combination therapy in Chinese patients with advanced solid tumors.
KM-501, developed using the Mebs-Ig platform, features dual-antibody ADC targeting two distinct domains of HER2. It is designed for treating locally advanced or metastatic solid tumors that are HER2 positive or exhibit expression, amplification, or mutation, including advanced tumors with low HER2 expression. The Investigational New Drug (IND) application for KM-501 was approved by the National Medical Products Administration (NMPA) in March, and it is currently undergoing a Phase I dose escalation study. Preclinical data suggests that KM-501 outperforms control drugs DS-8201 and Herceptin in terms of endocytosis rate, internalization rate, and in vitro inhibitory activity, demonstrating superior efficacy in tumor models with both high and low HER2 expression.
Sintilimab, a PD-1 monoclonal antibody co-developed by Innovent and Eli Lilly and Company, has been approved for seven indications and is included in China’s National Reimbursement Drug List (NRDL).- Flcube.com
