Regeneron, SillaJen in Clinical and Supply Pact

Regeneron Pharmaceuticals and SillaJen, Inc. have entered a new clinical and supply agreement for a Phase Ib dose-escalation study in kidney cancer. The study will evaluate Regeneron's PD-1 inhibitor, REGN2810, in combination with SillaJen's oncolytic vaccinia virus, Pexa-Vec, in patients with previously treated metastatic or unresectable renal cell carcinoma.

The trial is designed to evaulate the safety and efficacy of REGN2810 in combination with Pexa-Vec compared to treatment with REGN2810 as monotherapy. Pexa-Vec has been shown to increase inflammation in the tumor micro-environment and potentially reverse immunosuppression by activating T-cell mediated anti-tumor immune response. This may help "prime" the tumor by increasing sensitivity to anti-PD-1 treatment, such as REGN2180. 
 
The trial will be conducted and funded by SillaJen based on a mutually developed study design and Regeneron will provide REGN2810. Regeneron, in collaboration with Sanofi, is developing REGN2810 both alone and in combination with other therapies for the treatment of various cancers.
 
"We are pleased to announce this immuno-oncology agreement with Regeneron—another company doing groundbreaking work in oncology," said Eun Sang Moon, MD, DDS, chief executive officer of SillaJen. "We believe that there may be synergies between our compounds and look forward to investigating this in our upcoming clinical trial in renal cell carcinoma."
 
"Pairing our PD-1 inhibitor with other innovative approaches like Pexa-Vec allows us to evaluate multiple routes in the quest to provide important new treatments to people in need," Dr. Israel Lowy, vice president of Translation Sciences and Oncology, Regeneron. "Renal cell carcinoma is a devastating and currently under-treated disease, and combination therapies that enable the body's immune response in novel ways may help improve these patients' lives."