Glenmark licenses cancer drug from China’s Alphamab, 3D Med


India’s Glenmark Pharma has added to its oncology pipeline by licensing rights to a checkpoint inhibitor from China’s Jiangsu Alphamab Biopharmaceuticals and 3D Medicines in markets outside North America and Europe.

The deal covers the subcutaneously-administered PD-L1 inhibitor envafolimab (also known as KN035), which is already approved in China for previously treated microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) advanced solid tumours under the Enweida brand name.

Most of the PD-1/PD-L1 inhibitors on the market need to be given intravenously, and a subcutaneous option can make treatment easier and quicker to administer for patients and physicians.

Envafolimab was the first drug in the class to be approved in a subcutaneous formulation. However, it has since been joined by Roche’s Tecentriq (atezolizumab) and other drugmakers, including MSD and Bristol-Myers Squibb, have injectable versions of their products in late-stage development.

Specific terms of the deal haven’t been disclosed, but Glenmark has claimed rights to the drug in India, Asia Pacific, the Middle East and Africa, Russia, Commonwealth of Independent States (CIS), and Latin America in return for a “low double-digit million” payment in US dollars to Alphamab, up until envafolimab’s launch in one of these territories.

The Chinese company is also in line for “triple-digit million” dollar milestone payments based on sales performance as well as royalties on sales. Alphamab will also be responsible for manufacturing envafolimab for Glenmark.

The Indian drugmaker’s chairman and managing director, Glenn Saldanha, described the deal as “transformational” and an “important milestone” for the branded and generic medicines manufacturer as it builds a position in immuno-oncology.

Glenmark has been working towards building its branded medicines business, with an emphasis on the core therapeutic areas of dermatology, respiratory and oncology.

“We are excited at the opportunity to take this innovative immuno-oncology product to cancer patients across the emerging markets and meaningfully contribute towards improving their access to potentially life-saving treatment,” said Saldanha.

In the US, envafolimab is being developed by San Diego company TRACON Pharma, which is running a phase 2 trial of the drug in soft tissue sarcoma (STS), including undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS), and has rights in the US, Canada, and Mexico.

Alphamab and 3D Med, meanwhile, are running a phase 3 study in patients with advanced biliary tract cancer (BTC) in China.