ISA Pharmaceuticals and Regeneron Announce Strategic Immuno-Oncology Collaboration

Leiden, The Netherlands, December 18, 2017, -- ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company, and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced a clinical collaboration to advance ISA101, an immunotherapy targeting human papillomavirus type 16 (HPV16)-induced cancer, in combination with cemiplimab (REGN2810), a PD-1 (programmed cell death protein 1) antibody. Regeneron and ISA will jointly fund and conduct clinical trials of the combination treatment in cervical cancer and head-and-neck cancer.

Expression of HPV oncoproteins contributes to the development of cervical and head-and-neck cancers, and approximately 55 percent of cervical cancers and over 60 percent of head-and-neck cancers are HPV16 positive.^[1]

ISA and Regeneron will share clinical trial costs and exchange product supply. In addition, Regeneron will provide an upfront payment and an equity investment in exchange for an option to an exclusive, global license for ISA101. If Regeneron exercises its option to commercialize ISA101, there is potential for various milestone payments and tiered royalty payments to ISA contingent on regulatory approvals, sales and additional indications. Further financial details were not disclosed.

"Regeneron continues to expand and advance our immuno-oncology program by studying multiple combination therapies in order to fully explore the scientific possibilities in this relatively new field," said Israel Lowy, M.D., Ph.D., Vice President Clinical Sciences, Head of Translational Science and Oncology at Regeneron. "Early clinical results with ISA101 in HPV16-positive indications have been promising, and we're eager to investigate the impact of adding cemiplimab with the goal of further enabling the body's immune system to attack the cancer."

"This collaboration with Regeneron is a strong validation of our proprietary SLP^® (Synthetic Long Peptides) platform and know-how," added Ronald Loggers, Chief Executive Officer of ISA Pharmaceuticals. "We are proud to work with Regeneron, a science- and technology-driven biotechnology company, and aim to further strengthen our pioneering role in the development of innovative treatment options for oncology indications with a high unmet medical need." 

Cemiplimab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement for immuno-oncology therapeutics, and was developed using Regeneron's proprietary VelocImmune^® technology that yields optimized fully-human antibodies. Cemiplimab is currently being studied as a monotherapy in multiple cancers - including cutaneous squamous cell carcinoma (CSCC), basal cell carcinoma (BCC), non-small cell lung cancer (NSCLC) and cervical cancer - and in various therapeutic combinations. Cemiplimab is currently under clinical development, and its safety and efficacy has not been fully evaluated by any regulatory authority.