Replimune Group provides regulatory update on IGNYTE, data from ARTACUS trial

The company also shared a new data snapshot from the IGNYTE cohort of anti-PD1 failed non-melanoma skin cancer patients and data from the ARTACUS trial evaluating RP1 as monotherapy for skin cancer in patients who have had solid organ or hematopoietic cell transplants. IGNYTE Regulatory Update: The company recently participated in a Type C meeting with the U.S. Food and Drug Administratio. During the discussion, the FDA acknowledged that the anti-PD1 failed melanoma population is one of unmet need. The FDA agreed with an anti-PD1 failed melanoma confirmatory study design concept consisting of a 2-arm randomized trial with physician’s choice of treatment as a comparator arm in the study population. Full protocol development is currently underway. Data Overview from Phase 1/2 ARTACUS Clinical Trial of RP1 Monotherapy: As previously presented, treatment with RP1 monotherapy in the Phase 1/2 ARTACUS clinical trial in skin cancer patients who have had solid organ or hematopoietic cell transplants led to an ORR of 34.8%. These patients are generally not eligible for anti-PD1 therapy which could precipitate transplant rejection. Most responses were ongoing as of the data cutoff date of September 18, 2023. There was no evidence of allograft rejection. Initial Data Snapshot from the IGNYTE Cohort of RP1 in Anti-PD1 Failed NMSC: The NMSC data reported from the IGNYTE trial is from the first 30 patients enrolled in the cohort. The data show that treatment with RP1 in combination with nivolumab led to an ORR of 30% which is consistent with data from the anti-PD1 failed melanoma cohort with approximately a third of patients responding and 60% demonstrating clinical benefit. Portfolio Update: As previously shared, the company presented strong data with RP2 in uveal melanoma during a plenary session at the 20th International Congress of the Society for Melanoma Research in November. Based on the data in this population, planning is underway for a randomized controlled clinical trial of RP2 in second line uveal melanoma with the company intending to investigate other rare cancer opportunities as target indications. To focus on near term priority studies, including the RP1 Phase 3 confirmatory study in anti-PD1 failed melanoma and the RP2 registrational study in uveal melanoma, RP2/3 development in squamous cell carcinoma of the head and neck and colorectal cancer is being discontinued. The 2L hepatocellular carcinoma trial will continue with RP2 only. At this time, development of RP3 will be discontinued. As of September 30, 2023, cash and investments total $496.8M. We expect that the reprioritization of the portfolio will extend the cash runway into early 2026.