Glenmark Pharmaceuticals has entered (PDF) the subcutaneous checkpoint inhibitor space, agreeing to pay "low double-digit millions" for the chance to launch envafolimab in markets including India.
The anti-PD-L1 monoclonal antibody racked up a global first in 2021 when authorization in China made it the only approved subcutaneous checkpoint inhibitor anywhere. Subcutaneous formulations slash the time taken to give immunotherapies, which typically require patients to undergo 30-minute infusions every three or six weeks, and Merck & Co., Pfizer and Roche have all invested in the delivery format.
Glenmark’s deal with 3D Medicines and Jiangsu Alphamab Biopharmaceuticals establishes the Indian drugmaker as a new subcutaneous immunotherapy player in its home country, as well as in Asia Pacific, the Middle East, Africa, Russia and some neighboring countries, and Latin America.
The deal is worth “a low double-digit million U.S. dollar amount” up to the launch of envafolimab. Once the drug is on the market, Glenmark could pay “additional triple-digit million U.S. dollar milestones” tied to sales performance and royalties. Alphamab will supply the product to Glenmark.
Under Glenmark, a molecule that has been given to more than 30,000 patients in China could come to other markets. Envafolimab is yet to secure approval in the U.S., where Roche could become the first company to sell a checkpoint inhibitor this year, but Tracon Pharmaceuticals is working to change that.
In 2019, Tracon struck a deal to develop envafolimab for the treatment of sarcoma in North America. The biotech expects to have final data from a phase 2 trial in the third quarter and has previously discussed its intent to file for accelerated FDA approval on the strength of the results.
Cash is a potential obstacle to the realization of those plans. Tracon ended September with $7.8 million to its name and told investors it had the money to keep going “into early 2024.” Inhibrx, the biotech that Sanofi swooped on this week, later agreed to pay $3 million upfront to license a product development platform but cash remains tight.