="text-align: center;">ISA Pharmaceuticals Announce I-O Collab Against HPV-related Cancer
Regeneron Pharmaceuticals and Netherlands-based ISA Pharmaceuticals have now entered a clinical collaboration to advance ISA101, an immunotherapy targeting human papillomavirus type 16 (HPV16)-induced cancer, combined with Regeneron’s anti-PD-1 candidate REGN2810 (cemiplimab).
The human papillomavirus (HPV) is known for its ability to cause cancer, including cervical and head and neck cancer. Based in Leiden, ISA’s target choice is type 16 HPV, which is known to be present 55% of cervical cancers and 60% of head and neck cancers.
Regeneron Director of Corporate Communications Alexandra Bowie said the partners plan to conduct two studies — one in cervical cancer and the other in HPV16-positive head and neck cancer. Bowie and ISA Chief Business Officer Gerben Moolhuizen declined to disclose the phase of the trials. Moolhuizen said the trials “could potentially lead to registration.”
The partners will share costs of the trials, both of which are slated to start next year. Regeneron also gained an option to license exclusive, worldwide rights to commercialize ISA101. ISA receives an upfront payment and equity investment from Regeneron for the option. If Regeneron exercises the option, ISA would be eligible for milestone payments and tiered royalties. Moolhuizen said total payments to ISA could “well exceed” $500 million, 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.
The drug is currently under clinical development, and its safety and efficacy has not been fully evaluated by any regulatory authority.
