Roche's First-in-Class Anti-TIGIT Monoclonal Antibody Tiragolumab Granted IND Approval in China for Esophageal Squamous Cell Carcinoma

Source | Jike Pharma News

On August 25, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) announced that tiragolumab, a Class 1 novel biologic developed by Roche, has received implicit approval for clinical trials. The proposed indication is combination therapy with atezolizumab for unresectable locally advanced recurrent or metastatic esophageal squamous cell carcinoma. Tiragolumab is a monoclonal antibody targeting T-cell immunoglobulin and ITIM domain protein (TIGIT). This marks its first clinical trial approval in China, while globally it is currently in Phase 3 clinical development.

Screenshot source: CDE official website

Tiragolumab is a fully humanized monoclonal antibody targeting TIGIT, developed by Roche. TIGIT is an inhibitory receptor highly expressed on tumor-infiltrating T cells in various cancer types. It suppresses T-cell activation by competing with CD226 for binding to PVR, thereby disrupting CD226-mediated activation mechanisms. In China, multiple companies have invested in the development of TIGIT antibodies. Those that have received clinical trial approval include Innovent Biologics’ IBI939 (currently in Phase I trials) and BeiGene’s BGB-A1217 (currently in Phase I trials). Three TIGIT antibodies currently in preclinical development are Henlius’ HLX53, Junshi Biosciences’ JS006, and Stenvivo Biopharma’s mAb-7.

According to ClinicalTrials.gov, Tiragolumab is currently being evaluated in 11 clinical trials targeting non-small cell lung cancer (Phase III), small cell lung cancer (Phase III), gastric adenocarcinoma, gastroesophageal junction cancer, esophageal cancer (Phase Ib/II), and pancreatic adenocarcinoma (Phase Ib/II), among others. Studies have shown that Tiragolumab can inhibit TIGIT activity and has demonstrated consistent safety and tolerability in ongoing clinical trials. Tiragolumab is the TIGIT inhibitor with the most advanced global development progress.

On June 8 this year, Roche submitted a clinical trial application for tiragolumab in China. This marks the first approval of clinical trials for this product in China, with the proposed indication being unresectable locally advanced recurrent or metastatic esophageal squamous cell carcinoma. Patients with advanced or metastatic esophageal squamous cell carcinoma have poor prognosis after first-line treatment and limited subsequent treatment options. According to data from the 2017 Global Burden of Disease Study, China accounts for nearly half of the global burden of esophageal cancer incidence and mortality. Moreover, 70% of esophageal cancer patients in China are diagnosed at mid-to-late stages, and over 90% of cases are histologically classified as squamous cell carcinoma.

References:

[1] Center for Drug Evaluation, National Medical Products Administration. Retrieved 2020-08-25, from http://www.cde.org.cn/news.do?method=changePage&pageName=service#

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