Regeneron and ISA Pharma to advance immuno-oncology treatment

Collaboration to conduct clinical trials of the combination treatment in both cervical and head-and-neck cancer.

Expression of HPV oncoproteins contributes to the development of cervical and head-and-neck cancers, and approximately 55% of cervical cancers and over 60% of head-and-neck cancers are HPV16 positive.

Regeneron and ISA 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, 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, CEO 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."