Business
Replimune Reports Fiscal First Quarter 2024 Financial Results and Provides Corporate Update
Topline data from the registration-directed CERPASS clinical trial of RP1 combined with Libtayo® (cemiplimab-rwlc) in cutaneous squamous cell carcinoma
About this update from Replimune Group, Inc.
[{"type":"text","content":"Topline data from the registration-directed CERPASS clinical trial of RP1 combined with Libtayo® (cemiplimab-rwlc) in cutaneous squamous cell carcinoma expected in early Q4 2023 and Biologics License Application submission anticipated in Q1/2 2024 Cost sharing collaboration in cutaneous squamous cell carcinoma in the neoadjuvant setting entered into with Incyte Data snapshot for all 141 patients in the IGNYTE clinical trial cohort of RP1 in anti-PD1 failed melanoma expected Q4 2023 RP2 and RP3 Phase 2 programs; third-line colorectal cancer clinical trial initiated, first- and second-line hepatocellular carcinoma trials expected to initiate this quarter; Phase 1 clinical trial update expected at year end Strong balance sheet with cash runway into H2 2025 WOBURN, Mass., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of tumor-directed oncolytic immunotherapies, today announced financial results for the fiscal first quarter ended June 30, 2023 and provided a business update. “It was a productive quarter with positive updates for RP1 in anti-PD1 failed melanoma and RP2 in uveal melanoma presented at ASCO. The duration of responses are particularly impressive with all responding patients in the anti-PD1 failed melanoma 75 patient cohort presented late last year continuing without progression,” said Philip Astley-Sparke, CEO of Replimune. “We now look forward to presenting the top-line data from our registration-directed CERPASS trial of RP1 in combination with Libtayo in cutaneous squamous cell carcinoma (CSCC) as well as sharing an initial snapshot from the full patient population in the IGNYTE clinical trial cohort of RP1 combined with Opdivo in anti-PD1 failed melanoma later in the year. Commercial preparations are progressing, and in line with our ambition of establishing a major skin cancer franchise, we are pleased to announce that we have entered a cost sharing collaboration with Incyte to conduct a clinical trial for the neoadjuvant treatment of CSCC with RP1 and the oral PD-L1 inhibitor, INCB99280.” Program Highlights & Milestones RP1 CERPASS clinical trial of RP1 combined with Libtayo® in CSCC The trigger for the primary analysis from the registration-directed CERPASS clinical trial occurred in late June and data c...