Pharma Focus Asia

Innovent and Xuanzhu Partner on Sintilimab Combination Trial for Advanced Solid Tumors in China

Thursday, December 28, 2023

Innovent Biologics, Inc. (HKEX: 01801) and Xuanzhu Biopharma have recently disclosed a partnership involving a clinical trial and supply agreement for exploring combination therapies of sintilimab injection (TYVYT®) with KM-501, an innovative HER-2 bispecific ADC. The collaboration aims to investigate potential treatment options for advanced solid tumors in China.

According to the agreement, Innovent will supply sintilimab for the joint clinical trial, while Xuanzhu Biopharma will be responsible for conducting a Phase 1b clinical study to assess the safety and anti-tumor activity of the combination therapy in Chinese patients with advanced solid tumors.

TYVYT® (sintilimab injection) is a PD-1 inhibitor jointly developed by Innovent and Eli Lilly and Company in China. It has secured approval for seven indications and stands as the sole PD-1 inhibitor on the national reimbursement drug list for the first-line treatment of five high-incidence cancer types.

KM-501, developed through the Mebs-Ig platform, is a dual-antibody ADC designed to target HER2. It is intended for treating locally advanced/metastatic solid tumors displaying HER2-positive expression, amplification, or mutation. KM-501 received IND approval from the NMPA in March and is presently undergoing a phase I dose escalation study.

The collaboration marks a novel approach in cancer therapy, combining a PD-1 inhibitor with an ADC candidate. This strategy aims to enhance the effectiveness of immunotherapy and tackle potential drug resistance. The synergy lies in the ability of PD-1 immunotherapy to release suppressed T cells and the ADC drug's capability for anti-tumor killing through cytotoxic payload.

Dr. Hui Zhou, Senior Vice President of Innovent, expressed enthusiasm about the collaboration, emphasizing the strengthened position of sintilimab in cancer therapy. Dr. Xiaodong Zhu, General Manager of Xuanzhu Bio, sees the collaboration as a significant milestone for KM-501's development and commercialization strategy.

KM-501's unique design and promising pre-clinical results, outperforming control drugs DS-8201 and Herceptin, make it a compelling candidate. The collaboration between Innovent and Xuanzhu Biopharma aims to explore new possibilities for cancer patients and overcome tumor resistance through the combination of sintilimab and KM-501.



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