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]

WOBURN, Mass., Dec. 23, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ:REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that members of the Replimune management team will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 2:15 PM PT. A simultaneous webcast will be available in the Investors section of Replimune's website at replimune.com. A replay will be available for 30 days followi ...

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BOSTON, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced the pricing of its public offering of 6,923,000 shares of its common stock at a public offering price of $13.00 per share. In addition, in lieu of common stock to certain investors, Replimune today announced the pricing of its public offering of pre-funded warrants to purchase 3,846,184 shares of its common stock ...

WOBURN, Mass., Nov. 25, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced a proposed public offering of $125 million of shares of its common stock and pre-funded warrants to purchase shares of common stock. All securities in the offering will be offered by Replimune. In addition, Replimune intends to grant the underwriter a 30-day option to purchase up to an additional $18.75 mi ...

Replimune Group (REPL) announced that it has submitted a biologics license application (BLA) to the FDA for its lead pipeline candidate, RP1, in combination with Bristol Myers' (BMY) blockbuster immuno-oncology drug Opdivo (nivolumab) to treat adult patients with anti-PD1 failed advanced melanoma. The regulatory filing has been made under the FDA's Accelerated Approval pathway. In response to the encouraging news, the stock rose 19.4% in the after-market hours on Thursday. The stock is also rising today dur ...

WOBURN, Mass., Nov. 21, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that it has submitted a biologics license application (BLA) to the FDA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen. The submission was made under the Accelerated Appr ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |----------------------------------------------------------------------------|------------------------------------------| | | | | For the transition | | | Commissio ...

Exhibit 99.1 Replimune Reports Fiscal Second Quarter 2025 Financial Results and Provides Corporate Update • Completed Pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA) and remain on track to submit a BLA for RP1 plus nivolumab in anti-PD1 failed melanoma via the accelerated approval pathway before the end of the year • IGNYTE-3 confirmatory trial of RP1(vusolimogene oderparepvec) in advanced melanoma underway with first patient enrolled in August • Presented la ...

Oral presentation highlighting IGNYTE primary analysis data shows anti-tumor activity across all subgroups with injected and non-injected lesions responding with similar frequency, depth, duration, and kinetics Initial biomarker data shows increase in tumor CD8+ T cell and PD-L1 expression after dosing along with an increase in gene signatures associated with CD8+ T cells and inflammatory cytokines, highlighting the potential of RP1 plus nivolumab to generate a potent anti-tumor immune response WOBURN, Mass ...