Pharma major Glenmark has started a multi-country Phase 3 clinical trial for Envafolimab, an oncology drug that is currently being used in China for treatment of tumors, the company said in an exchange filing on September 5, sending the shares higher by over 2.5 percent in a weak market.
The drug has a subcutaneous mode of administration, which the company says promises to make immunotherapy more accessible and convenient for patients.
An exchange filing by Glenmark said that it has received approval from the Drugs Controller General of India (DCGI) to commence patient enrollment and dosing in India. The pharma company has already submitted a Clinical Trial Application (CTA) in Russia and is preparing to open additional trial sites in Brazil and Mexico to expand the footprint of the study.
Envafolimab is a novel anti-PD-L1 inhibitor that is administered subcutaneously, and was invented by Alphamab Oncology, co-developed with 3D Medicines (Beijing) since 2016.
Lung cancer remains the leading cause of cancer-related deaths worldwide, with Non-Small Cell Lung Cancer (NSCLC) comprising approximately 80-85% of cases, and 20-30% diagnosed at Stage III, Glenmark Pharma has said. While surgery remains an option stage III patients, the pharma company cited poor five-year survival rate, making a case for innovative and accessible immunotherapy options like Envafolimab.
"With its novel subcutaneous administration, Envafolimab has the potential to make cutting-edge immunotherapy more accessible and convenient for patients worldwide, especially in regions where healthcare resources are constrained," Dr Monika Tandon, Global Head of Clinical Development, Glenmark Pharmaceuticals said.
Glenmark had last year stuck a deal to further develop and commercialise Envafolimab in select regions of the world. According to news reports, investment bank HC Wainwright had in 2024 projected a Envafolimab could generate a revenue of $44 million for 2026, which could grow to $176 million by 2029.
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