Business
Replimune Reports Fiscal First Quarter 2025 Financial Results and Provides Corporate Update
Pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA) scheduled for September and BLA submission planned for 2H
About this update from Replimune Group, Inc.
[{"type":"text","content":"Pre-Biologics License Application (BLA) meeting with the U.S. Food and Drug Administration (FDA) scheduled for September and BLA submission planned for 2H 2024Enrollment of first patient in Phase 3 confirmatory trial of RP1 in advanced melanoma expected in Q3 2024Protocol finalized for registration-directed study of RP2 in uveal melanoma with study initiation activities underway WOBURN, Mass., Aug. 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 first quarter ended June 30, 2024 and provided a business update. \"We have had a highly productive quarter as we gear up for the upcoming pre-BLA meeting with the FDA and prepare to enroll the first patient in our confirmatory trial of RP1 in anti-PD1 failed melanoma,” said Sushil Patel, Ph.D., CEO of Replimune. “Our confidence in the RP1 program is reinforced by the IGNYTE primary analysis data that we presented in June, which demonstrates the potential of RP1 to address unmet needs in anti-PD1 failed melanoma patients who have not responded to prior existing therapies. We remain committed to advancing the clinical programs in our pipeline, including RP2, where we are preparing to enroll patients in a registration-directed study in uveal melanoma.” Program Highlights & Milestones RP1 RP1 combined with Opdivo® (nivolumab) in anti-PD1 failed melanoma In June, the Company announced positive topline primary analysis data by independent central review from the IGNYTE clinical trial of RP1 plus nivolumab in anti-PD1 failed melanoma. Topline results showed the 12-month overall response rate was 33.6% by modified RECIST 1.1 criteria, the primary endpoint as defined in the protocol, and 32.9% by RECIST 1.1 criteria, an additional analysis requested by the FDA. Responses from baseline were highly durable, with all responses lasting more than 6 months and median duration of response exceeding 35 months.The Company plans to present the full primary analysis data from the anti-PD1 failed melanoma cohort including key secondary endpoint data and subgroups for presentation at an upcoming medical congress.The Company expects to enroll its first patient in the Phase 3 confirmatory IGNYTE-3 trial in Q3 2024, prior to submitti...