Core Viewpoint - Replimune Group, Inc. has received FDA acceptance for its biologics license application for RP1 in combination with Opdivo to treat advanced melanoma, with a decision expected by July 22, 2025 [1][2]. Company Developments - The FDA has granted a priority review for the BLA and has not identified any potential review issues, indicating a smooth review process [2][5]. - Replimune's shares increased by 16.9% following the announcement, and the company has seen a 50.7% increase in share price over the past year, contrasting with a 14.8% decline in the industry [1][2]. - The BLA submission was based on data from the IGNYTE study, which assessed RP1 combined with Opdivo for patients with anti-PD-1 failed melanoma [3][4]. - The ongoing confirmatory phase III IGNYTE-3 study is evaluating the RP1/Opdivo combination for advanced melanoma patients who have progressed on anti-PD-1 and anti-CTLA-4 therapies [4][6]. Product Pipeline - RP1 has received Breakthrough Therapy designation for treating advanced melanoma patients who have previously received anti-PD-1 therapy [5]. - In addition to melanoma, Replimune is exploring the RP1/Opdivo combination for non-melanoma skin cancer indications and evaluating RP1 as a monotherapy for solid organ transplant recipients with skin cancers [6]. Market Position - Replimune currently has no approved products, making the successful development of RP1 and other pipeline candidates critical for the company's future [6].

Core Insights - The FDA has accepted the Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma, granting it Priority Review with a PDUFA action date of July 22, 2025 [1][2] - The BLA is supported by data from the IGNYTE trial, which evaluated RP1 in patients with anti-PD-1 failed melanoma, and a confirmatory Phase 3 trial, IGNYTE-3, is currently ongoing [1][3] Company Overview - Replimune Group, Inc. is a clinical stage biotechnology company focused on developing novel oncolytic immunotherapies, founded in 2015 [6] - The company's lead product candidate, RP1, is based on a proprietary strain of herpes simplex virus engineered to enhance tumor killing and activate systemic anti-tumor immune responses [5][6] Industry Context - Melanoma is the fifth most common cancer in the U.S., with approximately 100,000 new cases and 8,000 deaths estimated in 2024, highlighting a significant unmet need for effective treatments [4] - Current standard treatments include immune checkpoint blockade, but about half of patients do not respond or progress after treatment, indicating a gap in available options [4]

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]

Core Insights - Replimune Group, Inc. is set to present at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025, at 2:15 PM PT [1] Company Overview - Replimune Group, Inc. is a clinical stage biotechnology company founded in 2015, headquartered in Woburn, MA, focused on developing novel oncolytic immunotherapies [3] - The company's proprietary RPx platform utilizes a potent HSV-1 backbone aimed at maximizing immunogenic cell death and inducing a systemic anti-tumor immune response [3] - The RPx platform is designed for dual local and systemic activity, enabling direct virus-mediated tumor killing, releasing tumor-derived antigens, and modifying the tumor microenvironment to foster a strong systemic immune response [3] - Replimune's product candidates are expected to work synergistically with established and experimental cancer treatments, allowing for versatile development either alone or in combination with other therapies [3]

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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 ...

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 ...

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 ...

WOBURN, Mass., Nov. 08, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced the grant of inducement equity awards to newly hired non-executive employees. The Company granted equity awards to 12 employees as a material inducement to commencing their employment with the Company. The inducement awards consist of non-qualified stock options to purchase an aggregate of 19,390 shares of ...

Data from the IGNYTE primary analysis shows clinically meaningful activity across all subgroups, including those who had received prior anti-PD1 and anti-CTLA-4 or had primary resistance to anti-PD1 Injected and non-injected lesions responded with similar frequency, depth, duration and kinetics WOBURN, Mass., Sept. 15, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that data ...