SillaJen Files Clinical Study Report with FDA for REN026 Trial in Renal Cell Carcinoma Patients

South Korean biotech firm SillaJen, Inc. (KOSDAQ: 215600) has submitted a Clinical Study Report (CSR) to the US Food and Drug Administration (FDA) for REN026. This is a phase 1b/2a study that evaluates the safety and efficacy of Pexa-Vec, a modified vaccinia virus, when used alongside cemiplimab, an anti-PD-1 monoclonal antibody from Regeneron Pharmaceuticals Inc. (NASDAQ: REGN), for patients with advanced renal cell carcinoma (RCC).
The clinical trial, which began after a collaboration agreement with Regeneron in 2017 and received FDA approval in November of the same year, included 95 participants across 21 sites in the US, South Korea, and Australia. It concluded in February 2023 and was divided into four arms to assess different treatment combinations.
Notably, Arm C, which included patients new to immune checkpoint inhibitors (ICIs), showed a 23.3% overall response rate (ORR) and a median overall survival (OS) of 25.13 months, the highest among the study arms. Arm D, comprising patients who had received prior ICI treatment, also showed a robust ORR of 17.9%.
The study's findings are particularly significant given that patients in Arm D had typically lower response rates due to more extensive prior treatments. The results indicate that the combination therapy of Pexa-Vec and cemiplimab is well-tolerated and effective, offering a promising treatment option for RCC patients, irrespective of their prior ICI exposure.
Pexa-Vec is part of SillaJen’s SOLVE™ platform, which involves the creation of oncolytic vaccinia viruses designed to target cancer cells. The virus is engineered to express GM-CSF, enhancing its immunotherapeutic potential. As of March 31, 2023, Pexa-Vec has been administered to 595 cancer patients in international clinical trials, demonstrating efficacy through both intratumoral and intravenous delivery methods.
SillaJen, a publicly traded company, is dedicated to developing innovative cancer treatments, including Pexa-Vec and BAL0891, a mitotic checkpoint inhibitor. The company is also working on the GEEV® platform, which aims to enhance the delivery of oncolytic viruses to tumors while avoiding immune system interference. 

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