WOBURN, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced financial results for the fiscal second quarter ended September 30, 2025 and provided a business update. The Company announced on October 20, 2025, that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) resubmission of RP1 for the treatment of advanced melanom ...

Core Viewpoint - Replimune Group, Inc. has completed a Type A meeting with the FDA regarding the complete response letter for its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma treatment [1][2] Company Overview - Replimune Group, Inc. is a clinical stage biotechnology company focused on developing novel oncolytic immunotherapies, founded in 2015 and headquartered in Woburn, MA [4] - The company's lead product candidate, RP1 (vusolimogene oderparepvec), is engineered from a proprietary strain of herpes simplex virus designed to enhance tumor killing and activate systemic anti-tumor immune responses [3][4] FDA Interaction - The company is currently evaluating FDA feedback from the recent meeting to determine the next steps, with no clear path forward under the accelerated approval pathway established yet [2] - The CEO emphasized the unmet need in advanced melanoma and the favorable risk-benefit profile of RP1 observed in the IGNYTE trial, indicating a commitment to work with the FDA for a timely resolution [3]

Core Insights - Genelux Corporation has appointed Eric Groen as General Counsel, Corporate Secretary, Chief Compliance Officer, and Head of Business Development, effective July 1, 2025 [2][3] - Eric Groen brings over two decades of experience in the life sciences industry, with a strong background in legal expertise, business development, and navigating regulatory environments [3][4] - Groen's previous roles include General Counsel at Rani Therapeutics and a 20-year tenure at Amgen, where he was involved in significant transactions, including Amgen's $10 billion acquisition of Onyx Pharmaceuticals [4] Company Overview - Genelux is a late-stage clinical biopharmaceutical company focused on developing next-generation oncolytic immunotherapies for aggressive and difficult-to-treat solid tumors [6][7] - The company's leading product candidate, Olvi-Vec, is currently undergoing a Phase 3 trial for its efficacy and safety in treating platinum-resistant/refractory ovarian cancer [6][7] - Genelux utilizes its proprietary CHOICE™ platform to develop a library of engineered oncolytic vaccinia virus immunotherapeutic candidates, including Olvi-Vec [6][7] Appointment Details - Eric Groen's appointment is seen as pivotal for Genelux, as he aims to drive strategic growth, expand collaborations, and enhance regional partnerships [5] - Groen received an inducement award of stock options to purchase 270,000 shares at an exercise price of $2.83 per share, with a vesting schedule over four years [5]

Core Insights - Replimune Group, Inc. presented data on RP1 plus nivolumab at the 2025 ASCO Annual Meeting, highlighting robust responses in both injected and non-injected lesions, with deep injections showing higher response rates compared to superficial injections [1][2][4] Group 1: Clinical Trial Findings - The IGNYTE clinical trial involved 140 anti-PD-1 failed melanoma patients, showing an objective response rate (ORR) of 32.9% and a complete response rate of 15.0% [4] - Landmark overall survival (OS) rates at 1, 2, and 3 years were reported as 75.3%, 63.3%, and 54.8% respectively, with median OS not yet reached [4] - Deep injections resulted in higher ORR: 29.8% for superficial injections, 42.9% for deep/visceral plus superficial injections, and 40.9% for deep/visceral injections only [4] Group 2: Safety and Tolerability - RP1 injections into the liver and lung were generally well tolerated, with few organ-specific adverse events [4] - No bleeding events were reported after liver injections, and lung injections had low rates of pneumothorax, typically of low grade and manageable [4] - Standard disinfection procedures were confirmed sufficient for RP1 clean-up, with no transmission of RP1 reported to date [10] Group 3: Product Information - RP1 is Replimune's lead product candidate, engineered from a proprietary strain of herpes simplex virus, designed to maximize tumor killing potency and activate a systemic anti-tumor immune response [6][8] - The RPx platform aims to induce a strong and durable systemic response while being synergistic with various cancer treatment modalities [8]