$REGN and SillaJen Announce Immuno-Oncology Clinical Study Agreement

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Regeneron and SillaJen Announce Immuno-Oncology Clinical Study Agreement for Combination Treatment in Kidney Cancer

The open-label trial is expected to begin later this year, and is designed to evaulate the safety and efficacy of REGN2810 in combination with Pexa-Vec compared to treatment with REGN2810 as monotherapy. The study will initially open in Korea, with expansion to sites in the U.S.

Renal cell carcinoma is the most common type of kidney cancer in adults, and accounts for approximately three percent of adult malignancies and 90-95 percent of neoplasms arising from the kidney.

“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.”

Pexa-Vec has been shown to increase inflammation in the tumor micro-environment and potentially reverse the immunosuppressive microenvironment 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.

“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,” Israel Lowy, MD, PhD, 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.”

Under the terms of the agreement, the trial will be solely conducted and funded by SillaJen based upon 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.

“Given the results reported thus far for monotherapy anti-PD1 immunotherapy and initial studies of Pexa-Vec for the treatment of advanced kidney cancer, we believe the combination of Pexa-Vec and REGN-2810 holds great promise,” stated James Burke, MD, Chief Medical Officer of SillaJen. “This combination immunotherapy approach in RCC joins the oncolytic immunotherapy expertise of SillaJen with the well-known leadership of Regeneron in antibody targeted therapies.”

About Pexa-Vec and the SOLVE Platform
Pexa-Vec is the most advanced product candidate from SillaJen’s proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. The vaccinia strain backbone of Pexa-Vec has been used safely in millions of people as part of a worldwide vaccination program, and over 300 cancer patients have been treated with Pexa-Vec to date. Pexa-Vec was engineered to target common genetic defects in cancer cells by deleting its thymidine kinase (TK) gene, thus making Pexa-Vec dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express GM-CSF protein. GM-CSF complements the cancer cell lysis of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack. Pexa-Vec has been shown to be effective when delivered both intratumorally and systemically by intravenous administration. Pexa-Vec is currently being evaluated in a worldwide Phase 3 clinical trial for advanced primary liver cancer, and more information can be found at http://www.pexavectrials.com.

About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

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