Sanofi and Regeneron Pharmaceuticals will expand their investment for the clinical development of the PD-1 (programmed cell death protein 1) antibody cemiplimab in oncology and dupilumab in Type 2 allergic diseases. This strategic investment will allow the companies to evaluate cemiplimab and dupilumab in broad clinical development programs.


 
The companies will increase their investment in cemiplimab to $1.64 billion, an increase of approximately $1 billion over the initial 2015 agreement and will continue to equally fund development. Cemiplimab is being studied as monotherapy and in combination with other therapies in a wide range of cancers including advanced skin cancers, non-small cell lung cancer, cervical cancer and lymphomas, with more studies in other indications planned to begin this year. The companies expect to submit U.S. and EU applications for cemiplimab in advanced cutaneous squamous cell carcinoma in 1Q18.  


 
The additional investment in the dupilumab program aims to help accelerate new studies in chronic obstructive pulmonary disease, peanut allergy and grass allergy, as well as multiple allergic conditions. These areas are in addition to ongoing dupilumab clinical development in pediatric atopic dermatitis, pediatric asthma, eosinophilic esophagitis and nasal polyposis.  Dupixent (dupilumab) is approved for the treatment of adults with moderate-to-severe atopic dermatitis in the U.S. and EU and a U.S. supplemental biologics license application was submitted for uncontrolled, persistent asthma for patients aged 12 and over in the fourth quarter of 2017. 


 
The additional investment will also accelerate and expand development of REGN3500, an IL-33 antibody, with studies expected to be conducted in atopic dermatitis, asthma and chronic obstructive pulmonary disease.
 
“The ongoing collaboration between Sanofi and Regeneron underscores our commitment to partnering in the development of medicines to treat significant unmet medical needs,” said Elias Zerhouni, MD, global head of R&D at Sanofi. “The expansion of these clinical programs for both cempilimab and dupilumab should enable us to quickly identify treatment opportunities in other disease areas.”


 
Cemiplimab and dupilumab were invented by Regeneron using the company’s VelocImmune technology that yields optimized fully-human antibodies.