Replimune Group (NASDAQ: REPL) Submits Biologics License Application for RP1 in Combination with Nivolumab to FDA

On November 21, 2024, Replimune Group, Inc. (NASDAQ: REPL) made significant strides in the advancement of its lead product candidate, RP1. The company announced the submission of a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for RP1 in conjunction with nivolumab. This submission was specifically for the treatment of adult patients with advanced melanoma who have previously undergone an anti-PD1 containing regimen. The application was filed under the Accelerated Approval pathway.

Further, Replimune Group disclosed that the FDA has granted Breakthrough Therapy designation to RP1 when used in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen. Breakthrough Therapy designation is intended to hasten the development and assessment of therapies for severe diseases, particularly when early clinical data suggests a significant improvement over existing therapies on key clinical endpoints.

CEO of Replimune Group, Dr. Sushil Patel, emphasized the importance of these developments, highlighting the potential impact on patients with limited therapeutic options following progression on anti-PD1 containing regimens. The company’s Phase 3 IGNYTE-3 trial, evaluating RP1 alongside nivolumab in advanced melanoma patients who have experienced progression on anti-PD1 and anti-CTLA-4 therapy, or are ineligible for anti-CTLA-4 treatment, is actively enrolling participants.

RP1, also known as vusolimogene oderparepvec, serves as Replimune’s flagship product candidate. It is engineered from a proprietary strain of herpes simplex virus, further enhanced with a fusogenic protein (GALV-GP R-) and GM-CSF. The treatment is designed to enhance tumor-killing potency, promote immunogenic cell death within tumors, and trigger a systemic anti-tumor immune response.

Established in 2015 and headquartered in Woburn, MA, Replimune Group aims to revolutionize cancer treatment through the pioneering development of novel oncolytic immunotherapies. The company’s RPx platform utilizes a potent HSV-1 backbone to maximize immunogenic cell death and provoke a robust systemic anti-tumor immune response. With a focus on dual local and systemic activity, the RPx platform’s product candidates are anticipated to synergize with a wide array of existing and experimental cancer treatment modalities.

Investors and stakeholders are advised that forward-looking statements contained in this update are subject to various risks and uncertainties that could cause actual results to differ from expectations. Replimune Group commits to providing updated information as necessary.

The attached Exhibit 99.1 provides additional details about these notable developments for Replimune Group, Inc.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Replimune Group’s 8K filing here.

About Replimune Group

Replimune Group, Inc, a clinical-stage biotechnology company, focuses on the development of oncolytic immunotherapies to treat cancer. The company's proprietary tumor-directed 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, which is in Phase I/II clinical trials for a range of solid tumors; and that has completed Phase II clinical trials for treating cutaneous squamous cell carcinoma.