Replimune Gets Breakthrough Therapy Status and Submits RP1 Biologics License Application to FDA

Replimune Group, Inc., a clinical stage biotechnology firm listed on NASDAQ under the ticker REPL, has announced the submission of a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA). The application is for their product RP1, also known as vusolimogene oderparepvec, in conjunction with nivolumab, aimed at treating adult patients with advanced melanoma who have previously undergone an anti-PD1 regimen. This submission falls under the FDA's Accelerated Approval pathway.

In addition, the FDA has granted Breakthrough Therapy designation to RP1 when used with nivolumab in the same context. This designation is designed to speed up the development and review process for therapies that show potential for substantial improvement over existing treatments based on preliminary clinical evidence.

The Breakthrough Therapy designation was awarded following encouraging safety and clinical activity results from the IGNYTE clinical trial's anti-PD1 failed melanoma cohort. Sushil Patel, Ph.D., CEO of Replimune, expressed the significance of this milestone, emphasizing the potential new treatment option for melanoma patients who have limited alternatives after progressing on anti-PD1 containing treatments.

Replimune is currently enrolling patients for the confirmatory Phase 3 IGNYTE-3 trial. This trial focuses on RP1 combined with nivolumab for advanced melanoma patients who have not responded to anti-PD1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment.

RP1, Replimune’s lead product, is derived from a proprietary strain of the herpes simplex virus. This strain has been engineered to include a fusogenic protein (GALV-GP R-) and GM-CSF, with the goal of enhancing tumor cell killing, increasing the immunogenicity of tumor cell death, and activating a systemic anti-tumor immune response.

Founded in 2015 and headquartered in Woburn, Massachusetts, Replimune is dedicated to transforming cancer treatment through innovative oncolytic immunotherapies. The company's proprietary RPx platform is built on a robust HSV-1 backbone, designed to maximize immunogenic cell death and stimulate a systemic anti-tumor immune response. The RPx platform features dual local and systemic activity, selectively killing tumor cells and altering the tumor microenvironment to trigger a strong and lasting systemic response.

Replimune’s product candidates from the RPx platform are anticipated to work synergistically with many existing and experimental cancer treatments. This versatility allows them to be developed as standalone therapies or in combination with other treatment options.