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.
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.”
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