Pharma Pioneer

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

19 May 2024
2 min read

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. 

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!

图形用户界面, 文本, 应用程序, 聊天或短信

描述已自动生成

Immuneering Commences Phase 1/2a Trial with First Patient Dosed for RAF/RAS Mutated Solid Tumor Treatment
Pharma Pioneer
2 min read
Immuneering Commences Phase 1/2a Trial with First Patient Dosed for RAF/RAS Mutated Solid Tumor Treatment
19 May 2024
Immuneering Corporation, a clinical-stage oncology firm, has initiated a Phase 1/2a clinical trial for IMM-6-415, a novel Deep Cyclic Inhibitor (DCI) targeting the MAPK pathway.
Read →
Affimed N.V. Announces 2023 Financial Outcomes and Corporate Developments
Pharma Pioneer
2 min read
Affimed N.V. Announces 2023 Financial Outcomes and Corporate Developments
19 May 2024
AFM24 Clinical Trial Updates: In a Phase 1/2a study combining AFM24 with atezolizumab for non-small cell lung cancer (NSCLC) patients with EGFR-wildtype.
Read →
VRON-0200 Phase 1B Data Show Promise for Chronic Hepatitis B Functional Cure at 2024 APASL
Pharma Pioneer
3 min read
VRON-0200 Phase 1B Data Show Promise for Chronic Hepatitis B Functional Cure at 2024 APASL
19 May 2024
The preliminary safety findings from a Phase 1B clinical trial involving VRON-0200, a groundbreaking immunotherapy for chronic hepatitis B (HBV), were recently highlighted.
Read →
Candel Therapeutics Presents CAN-3110 Phase 1b Trial Progress at the 5th Annual Glioblastoma Summit
Pharma Pioneer
2 min read
Candel Therapeutics Presents CAN-3110 Phase 1b Trial Progress at the 5th Annual Glioblastoma Summit
19 May 2024
In a recent phase 1b clinical trial, patients received multiple injections of a novel immunotherapy, CAN-3110, developed by Candel Therapeutics.
Read →
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.