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Replimune Group, Inc. (NASDAQ: REPL) is a clinical-stage biotechnology company committed to advancing cancer treatment through innovative oncolytic immune-gene therapies. Founded in 2015 and headquartered in Woburn, Massachusetts, Replimune leverages its proprietary Immulytic™ platform to develop product candidates aimed at activating the immune system against solid tumors.
The core of Replimune’s portfolio includes RP1, RP2, and RP3, all based on genetically-engineered strains of herpes simplex virus 1 (HSV-1). These strains are modified to maximize tumor killing and stimulate a systemic anti-tumor immune response. RP1, the company’s lead product, is designed for enhanced tumor killing and has shown promising results in combination with anti-PD1 therapies. It is currently undergoing clinical trials for anti-PD1 failed melanoma and other skin cancers, with plans to submit a Biologics License Application (BLA) in 2H 2024.
Another notable candidate is RP2, which expresses an anti-CTLA-4 antibody-like protein to further enhance immune response. RP2 has demonstrated durable response rates in advanced uveal melanoma patients, a particularly challenging cancer type with limited treatment options. RP3, the third candidate in the pipeline, is engineered to express multiple immune-activating proteins, though its development has currently been paused to focus on higher priority programs.
Replimune's recent achievements include favorable safety profiles and substantial response rates in clinical trials. For instance, RP2 in combination with nivolumab showed a durable overall response rate of nearly 30% in patients with metastatic uveal melanoma. Additionally, RP1 has demonstrated significant anti-tumor activity in organ transplant recipients who typically cannot undergo systemic immunotherapy.
The company has established alliances with major pharmaceutical entities, such as Regeneron Pharmaceuticals, to further its clinical trials and explore combination therapies. Financially, Replimune is robust, with a cash runway extending into early 2026, thanks to strategic reprioritization and successful capital management.
Replimune is dedicated to evolving its portfolio and optimizing its RPx platform. The dual local and systemic mechanism of action of its therapies offers a versatile approach that can be combined with various other cancer treatment modalities, thus holding significant promise for the future of oncology.
Replimune Group, Inc. (NASDAQ: REPL) has announced a collaboration with Roche to advance its RP2/3 program for treating colorectal cancer (CRC) and hepatocellular carcinoma (HCC). The agreement includes cost sharing for clinical trials, with Roche supplying its FDA-approved drugs, atezolizumab and bevacizumab. This collaboration aims to enhance treatment options for patients and is aligned with Replimune's strategy to partner with industry leaders. The Phase 2 clinical trials are set to begin in the first half of 2023, focusing on various cancers.
Replimune Group, a clinical-stage biotechnology company based in Woburn, MA, announced a fireside chat presentation at the Piper Sandler 34th Annual Healthcare Conference on December 1, 2022, at 1:00 PM ET. The company focuses on developing tumor-directed oncolytic immunotherapies utilizing its proprietary RPx platform, which employs a potent HSV-1 backbone. This platform aims to induce systemic anti-tumor responses by killing tumors and altering the tumor microenvironment. Replimune was founded in 2015 and is publicly traded on NASDAQ under the symbol REPL.
Replimune Group Inc. (NASDAQ: REPL) is set to host an investor event on December 7, 2022, at 8:00 AM ET to present preliminary data from the six-month follow-up of its IGNYTE clinical trial involving RP1 and Opdivo® for melanoma patients who failed anti-PD1 therapy. The event will also explore the commercial potential of RP1 in skin cancer and provide updates on the RP2 and RP3 programs. Live access to the event will be available on the company’s website, with a replay option thereafter.
Replimune Group, Inc. (NASDAQ: REPL) reported its fiscal Q2 2022 results, highlighting significant progress in clinical trials for RP1, a novel oncolytic immunotherapy. The company completed enrollment in the CERPASS clinical trial for cutaneous squamous cell carcinoma (CSCC) and expects primary analysis data by H1 2023. Additionally, it secured a $200 million term loan extending its cash runway into 2025. Despite a net loss of $43.1 million for the quarter, an increase from the previous year’s loss, Replimune remains focused on its pipeline and upcoming data releases.
Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company, announced its participation at two upcoming conferences. The company will host a fireside chat during the BMO Biopharma Spotlight Series Oncology Day on November 9, 2022, at 7:30 am EST. Additionally, Replimune will participate in the 13th Annual Jefferies Global Healthcare Conference on November 16, 2022, at 1:30 pm GMT.
Investors can access a live webcast of the Jefferies conference via Replimune's website.
Replimune Group, Inc. (NASDAQ: REPL) has secured a $200 million non-dilutive term loan from Hercules Capital, extending its cash runway into 2025. This funding will facilitate key registration-directed trials for its oncolytic immunotherapies targeting advanced skin cancers. The loan includes multiple tranches, with an initial $30 million drawn at closing and up to $115 million contingent on performance milestones. This financial strategy provides Replimune with flexibility and reduces dilution risks while preparing for critical data releases and commercial preparations.
Replimune Group, Inc. (NASDAQ: REPL) reached its target enrollment of 180 patients for the CERPASS trial, evaluating RP1 in cutaneous squamous cell carcinoma (CSCC). Primary analysis data is expected in H1 2023. The initial cohort of 75 patients for the IGNYTE trial, assessing RP1 with Opdivo in anti-PD1 failed melanoma, has been enrolled, with data to be reported in Q4 2022. Financially, Replimune reported a net loss of $42.3 million for Q1 2022, an increase from $27.3 million in Q1 2021, with R&D expenses rising due to clinical advancements and personnel costs.
Replimune Group, a clinical stage biotechnology company specializing in tumor-directed oncolytic immunotherapies, announced its participation in two upcoming investor conferences. The BTIG Biotechnology Conference will take place on August 8, 2022, featuring a fireside chat at 11:00 am ET. The company will also present at the 2022 Wedbush PacGrow Healthcare Virtual Conference on August 10, 2022, with a fireside chat scheduled for 9:45 am ET. A live webcast will be available on Replimune's website.
Replimune Group (NASDAQ: REPL) announced the resignation of Jason Rhodes from its Board of Directors, effective June 3, 2022. Rhodes, a partner at Atlas Venture, served on the board since 2015 and was key during the company's Series A financing. His departure is attributed to increased commitments at Atlas Venture, including a new fund launch. CEO Philip Astley-Sparke expressed gratitude for Rhodes' contributions and highlighted the company's ongoing focus on oncolytic immunotherapies, anticipating significant data releases in the next 12 months.
Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company, will present at the Jefferies Healthcare Conference on June 9, 2022, at 9:30 AM ET. The event will be held at Marriott Marquis in New York. Founded in 2015, Replimune focuses on innovating tumor-directed oncolytic immunotherapies using its proprietary RPx platform. This platform utilizes an HSV-1 backbone to enhance immune responses against tumors while maintaining a strong safety profile. For more details, visit www.replimune.com.
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