About REPL

Founded: 2015
Employees: 465
CEO: Sushil Patel
WebsiteView website: www.replimune.com

Replimune Group, Inc., a clinical-stage biotechnology company, focuses on the development and commercialization of oncolytic immunotherapies to treat cancer in the United States and the United Kingdom. The company’s proprietary oncolytic immunotherapy product candidates are designed and intended to activate the immune system against cancer. Its lead product candidate is RP1, a selectively replicating version of HSV-1 that expresses GALV-GP R(-) and human GM-CSF for a range of solid tumors. The company is also developing RP2 that expresses an anti-CTLA-4 antibody-like protein to block the inhibition of the immune response otherwise caused by CTLA-4. The company was founded in 2015 and is headquartered in Woburn, Massachusetts.

Recent REPL News & Updates

Announcement • Jul 31

Replimune Announces Favorable Outcome of FDA Advisory Committee Meeting for RP1 in Advanced Melanoma

Replimune Group, Inc. announced the outcome of the U.S. Food and Drug Administration's (FDA) Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC), which discussed the Biologics License Application (BLA) resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy. The committee discussed two topics: (1) whether the single-arm IGNYTE study, as designed and conducted, allows for a reliable determination of the expected response rate and durability of response in the proposed population; and (2) the clinical meaningfulness of the response rate and duration of response reported in IGNYTE, and whether the observed responses are indicative of systemic antitumor activity attributable to RP1. The committee then voted 10 to 3, on the question: “Are the efficacy results from IGNYTE evaluable and clinically meaningful?” The FDA's target action date under the Class 1 resubmission is August 2, 2026. RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

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Recent REPL News & Updates

FDA Panel Favors Replimune Group RP1 Data for Advanced Melanoma Paving Path to Decision

Replimune Announces Favorable Outcome of FDA Advisory Committee Meeting for RP1 in Advanced Melanoma

Replimune: 'Sell' Continued Doubt On Single-Arm IGNYTE Trial For RP1 FDA Review

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