Business
Replimune Reports Fiscal Third Quarter 2024 Financial Results and Provides Corporate Update
Positive data update in December 2023 for all 140 patients in the IGNYTE clinical trial cohort of RP1 in anti-PD1 failed melanoma demonstrating durability of
About this update from Replimune Group, Inc.
[{"type":"text","content":"Positive data update in December 2023 for all 140 patients in the IGNYTE clinical trial cohort of RP1 in anti-PD1 failed melanoma demonstrating durability of responseCentrally reviewed 12-month primary analysis data from IGNYTE trial of RP1 in anti-PD1 failed melanoma and biologics license application (BLA) submission expected in 2H 2024Phase 3 confirmatory trial of RP1 in anti-PD1 failed melanoma skin cancers expected to initiate 2H 2024Cash runway extended to fund operations into 2H 2026 WOBURN, Mass., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2023, and provided a business update. “The collective data for RP1 shows that it has the potential to be a safe and effective treatment option for patients with a range of different skin cancers in various treatment settings. We plan to submit a BLA for the treatment of patients with anti-PD1 failed melanoma in 2H 2024. Subsequently, we will explore the potential for additional submissions based on the evolving data from our multiple non-melanoma skin cancer studies,” said Philip Astley-Sparke, CEO of Replimune. “We are excited about the data we have seen to-date with RP2 including as monotherapy in very difficult to treat tumors. Planning is underway for a clinical trial in advanced uveal melanoma as a foundational study for establishing a rare cancer franchise. Following the decision to reprioritize our pipeline, we have extended our cash runway to fund operations into 2H 2026, leaving us well positioned to bring our lead product to market.” Program Highlights & Milestones RP1 RP1 combined with Opdivo® (nivolumab) in anti-PD1 failed melanoma The Company presented initial data from the full population enrolled into the registration directed anti-PD1 failed melanoma cohort from the IGNYTE clinical trial in December 2023. In the full data set of 156 patients (140 patients from the registration-directed expansion cohort and 16 anti-PD1 failed cutaneous melanoma patients from the prior phase 2 cohort), had an overall response rate (ORR) of 31.4% with a complete response rate (CR) of 12% showing activity consistent with the prior snapshot of 91 patients. RP1 combined wit...