Collaborations, Immuno-oncology

Sanofi, Regeneron up the ante on PD-1 I/O program by a billion dollars

With pivotal trial work well in hand and high hopes to start grabbing approvals for the world’s sixth PD-1/L1 checkpoint drug this year, Sanofi and its partners at Regeneron are boosting their development budget for cemiplimab to a minimum of $1.65 billion — a cool billion dollars more than they had pencilled into their development agreement three years ago.

George Yancopoulos

Investigators at Sanofi $SNY and Regeneron $REGN have been bullish about carving out a place for themselves in one of the most competitive fields in immuno-oncology. As we reported recently, the Cancer Research Institute has found 164 PD-1/L1s in preclinical and clinical development as developers rush to compete in a market segment led by Merck and Bristol-Myers Squibb. There are three in Phase III — the program from Sanofi/Regeneron, PDR001 from Novartis and INCSHR-1210 from Incyte/Jiangsu Hengrui — and 9 in Phase II.

The development partners, who have been winding down the antibody side of their collaboration, will also commit new funds to push Dupixent and the IL-33 antibody REGN3500 further down the clinical path. The partners see Dupixent as a drug that can inspire a whole pipeline worth of projects.

To help pay for its end of the added investment, Sanofi will sell off a chunk of the Regeneron stock it acquired when partnering with the big biotech.

“Cemiplimab has demonstrated strong pivotal clinical results in advanced cutaneous squamous cell carcinoma and is a core backbone of our immuno-oncology development program, both as a monotherapy and in combination with other therapies. The increased funding will enable us to investigate this important new therapy in a variety of cancers as rapidly as possible,” said George Yancopoulos, the chief scientist at Regeneron. “Similarly, dupilumab has the potential to be a pipeline in a single product given its unique activity on the IL-4/13 pathway, which is a critical driver of Type 2 allergic inflammation. We look forward to rapidly advancing a broad development program to further investigate the potential of dupilumab to help multiple different patient populations in need.”


The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 24,000+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Immuno Oncology 360

Bio NJ Annual Dinner