Replimune Announces RP2 Development Program Advances with First Patients Enrolled in Metastatic Uveal Melanoma and Hepatocellular Carcinoma Clinical Trials

Core Insights - Replimune Group, Inc. has initiated patient enrollment in clinical trials for RP2 targeting metastatic uveal melanoma and hepatocellular carcinoma (HCC) [1][2] Group 1: RP2 Clinical Trials - The RP2-202 trial is a randomized phase 2/3 study enrolling approximately 280 patients to evaluate RP2 in combination with nivolumab versus ipilimumab plus nivolumab in checkpoint inhibitor-naïve patients with metastatic uveal melanoma [3] - The primary endpoints for the RP2-202 trial include overall survival and progression-free survival, with key secondary endpoints being overall response rate and disease control rate [3] - An earlier Phase 2 study presented at ASCO 2024 showed RP2 alone or combined with nivolumab had an overall response rate of 29.4% and a disease control rate of 58.8% in a cohort of 17 patients [2] Group 2: Hepatocellular Carcinoma (HCC) Trials - The RP2-003 trial is an open-label study enrolling 30 patients to evaluate RP2 combined with atezolizumab and bevacizumab in patients with advanced unresectable, recurrent, or metastatic HCC [5] - The primary endpoint for the RP2-003 trial is overall response rate per modified RECIST 1.1 criteria, with key secondary endpoints including overall response rate per RECIST modified for HCC and duration of response [5] - HCC is noted as the third leading cause of cancer-related deaths globally, with a poor prognosis and most cases diagnosed at an advanced stage [4] Group 3: About RP2 - RP2 is a derivative of RP1, engineered from a new strain of herpes simplex virus, designed to enhance tumor killing and activate systemic anti-tumor immune responses [6] - The product aims to deliver proteins directly to tumor sites and draining lymph nodes, focusing on maximizing efficacy while limiting off-target toxicity [6] Group 4: Company Overview - Replimune Group, Inc. was founded in 2015 and is headquartered in Woburn, MA, with a mission to innovate cancer treatment through oncolytic immunotherapies [7][8] - The company's RPx platform is based on a potent HSV-1 backbone, designed to induce systemic anti-tumor immune responses and synergize with various cancer treatment modalities [8]