Replimune's RP1 Receives FDA Breakthrough Therapy Designation and BLA Submission for Advanced Melanoma

Key Insights

• Replimune has submitted a Biologics License Application (BLA) to the FDA for RP1 in combination with nivolumab to treat advanced melanoma patients after anti-PD-1 therapy.
• The FDA granted Breakthrough Therapy designation to RP1 plus nivolumab, expediting its development for patients with limited options after anti-PD-1 regimen failure.
• RP1 (vusolimogene oderparepvec) is an oncolytic immunotherapy designed to maximize tumor killing, enhance immunogenicity, and activate a systemic anti-tumor immune response.

Replimune Group, Inc. has announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its oncolytic immunotherapy, RP1 (vusolimogene oderparepvec), in combination with nivolumab. This therapeutic approach targets adult patients with advanced melanoma who have previously progressed on an anti-PD-1 containing regimen. The FDA has also granted RP1 Breakthrough Therapy designation for the same indication, potentially accelerating its development and review.

The Breakthrough Therapy designation is reserved for therapies demonstrating substantial improvement over existing options for serious conditions based on preliminary clinical evidence. Replimune's application is supported by safety and clinical activity data from the anti-PD-1 failed melanoma cohort of the IGNYTE clinical trial.

According to Sushil Patel, Ph.D., CEO of Replimune, this marks a significant step toward providing a new treatment option for melanoma patients with limited alternatives after progressing on anti-PD-1 therapies.

RP1: Oncolytic Immunotherapy

RP1 (vusolimogene oderparepvec) is Replimune’s leading candidate, engineered from a proprietary strain of herpes simplex virus. It is genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF to maximize tumor cell death, enhance the immunogenicity of cell death, and stimulate a systemic anti-tumor immune response.

Ongoing Phase 3 Trial

The confirmatory Phase 3 IGNYTE-3 trial is currently enrolling patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapy or are ineligible for anti-CTLA-4 treatment. This trial aims to further evaluate the efficacy and safety of RP1 in combination with nivolumab.