Sanofi and Regeneron are boosting their investment in development programmes for the PD-1 antibody cemiplimab in oncology and dupilumab in Type 2 (tissue specific) allergic diseases.
Investment in cemiplimab will be increased by around $1 billion over that agreed as per the companies’ 2015 deal to $1.64 billion, and Sanofi and Regeneron will continue to equally fund the drug’s development.
Cemiplimab is being assessed as monotherapy and in combination with other therapies across a wide range of cancers, but US and EU regulatory applications for the drug in advanced cutaneous squamous cell carcinoma are expected first, sometime during the current quarter.
This follows data from the pivotal Phase II EMPOWER-CSCC 1 study, showing an overall response rate of 46.3 percent in patients with the condition, the second deadliest skin cancer after melanoma.
The extra investment in dupilumab is designed to accelerate planned new studies in chronic obstructive pulmonary disease, peanut allergy and grass allergy, as well as in patients who have multiple allergic conditions.
The drug is already being developed for paediatric atopic dermatitis, paediatric asthma, eosinophilic esophagitis and nasal polyposis, and has been approved under the trade name Dupixent for adults with moderate-to-severe atopic dermatitis in the US and EU.
The firms said they submitted a US supplemental biologics license application for uncontrolled, persistent asthma for patients aged 12 and over in the fourth quarter of 2017, potentially expanding its reach.
“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, global Head of R&D at Sanofi, commenting on the move. “The expansion of these clinical programs for both cemiplimab and dupilumab should enable us to quickly identify treatment opportunities in other disease areas.”
Development of the IL-33 antibody REGN3500 is also to be accelerated, with studies in atopic dermatitis, asthma and chronic obstructive pulmonary disease on the cards, the firms noted.
9th January 2018