Try our mobile app

Replimune Reports Fiscal First Quarter 2024 Financial Results and Provides Corporate Update

Published: 2023-08-03 12:00:00 ET
<<<  go to REPL company page

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 collection activities are nearly complete. Guidance for the top line data disclosure has been updated from Q3 to early Q4 2023 as a result of the independent review read rate tracking behind projections. Assuming positive data demonstrating overall clinical benefit, the Company plans to submit a biologics license application (BLA) for RP1 in Q1/2 2024, with the potential to combine the filings for both the CERPASS clinical trial and the IGNYTE anti-PD1 failed melanoma cohort.
  • Announced Clinical Trial Collaboration with Incyte to Evaluate RP1 and INCB099280 in CSCC
    • Under the terms of the agreement, Incyte will initiate and sponsor a clinical trial of INCB99280 (oral PD-L1 inhibitor) and RP1 in approximately 40 patients with unresectable, high risk CSCC in the neoadjuvant setting. Replimune will supply Incyte with RP1 for the study and share costs.
  • RP1 combined with Opdivo®(nivolumab) in anti-PD1 failed non-melanoma skin cancers
    • Recruitment remains ongoing into the cohort of patients with anti-PD1 failed non-melanoma skin cancers, including CSCC, with a data update expected from the first 30 patients with at least six months follow up in early Q4 2023.
  • RP1 in solid organ transplant recipients with skin cancers
    • Presented initial data from the ARTACUS clinical trial of RP1 monotherapy in solid organ transplant recipients with skin cancers at the American Transplant Congress (ATC) Meeting in June. These data included 11 evaluable patients with cutaneous squamous cell carcinoma (N=10) and Merkel cell carcinoma (N=1).
    • The data demonstrated an overall response rate (ORR) of 27.3%, with all responders achieving confirmed complete responses (CR).
    • RP1 monotherapy was well tolerated, and the safety profile was similar to non-immunocompromised patients with advanced skin cancers (IGNYTE study). No immune-mediated adverse events or evidence of allograft rejection were observed.
  • RP1 combined with Opdivo in anti-PD1 failed melanoma
    • Presented updated data from the ongoing IGNYTE clinical trial at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in June. These data included the first 75 patients from the anti-PD1 failed melanoma cohort combined with the 16 anti-PD1 failed melanoma patients from the prior all comers 30 patient melanoma cohort (N=91 in total).
    • The data demonstrated an overall response rate (ORR) of 37.4%, with clinically meaningful activity across the range of anti-PD1 failed cutaneous melanoma settings enrolled, including in patients with moderate-high tumor burden and with visceral disease.
    • Systemic activity was seen in both injected and un-injected lesions, with both responding with similar durability and kinetics, including in un-injected visceral disease.
    • RP1 continues to be generally well tolerated with safety data showing predominantly ‘on target’ flu-like Grade 1-2 side effects indicative of systemic immune activation. Grade 3 treatment related events were rarely seen in the 91-patient group, with a range of Grade 3 events in one patient each, and two Grade 3 events of fatigue. There were two Grade 4 treatment related events (elevated lipase, and cytokine release syndrome) and no treatment related Grade 5 events.
    • The Company remains on track to announce snapshot data for all patients (N=141) in Q4 2023 by which point all patients will have had at least 6 months follow up, prior to the per protocol primary analysis at 12 months post the last patient enrolled.

RP2 and RP3

  • RP2 combined with nivolumab in uveal melanoma
    • Presented updated data from an ongoing Phase 1b trial of RP2 at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in June. To date 17 patients have been treated with RP2 as monotherapy (N=3) or in combination with nivolumab (N=14) to date, with enrollment of uveal melanoma patients into this clinical trial now being complete.
    • In uveal melanoma, four of the 14 evaluable patients have thus far responded to treatment (28.6%), including metastatic tumors in the liver and bone. The final three of 17 patients remain on treatment, but currently have insufficient follow-up data to determine response outcome as of the cut-off date. Three of the four responses are ongoing at 9, 12 and 21 months, including for patients with liver and bone metastases, with the fourth patient having progressed at 15 months.
    • The safety profile as monotherapy and in combination with nivolumab was generally well tolerated with no additive adverse events observed.
  • RP2 and RP3 Phase 2 program
    • RP2 and RP3 in combination with atezolizumab and bevacizumab in third-line colorectal cancer (CRC)
      • Two signal finding cohorts of 30 patients each will be enrolled in collaboration with Roche. The first cohort will enroll patients to be treated with atezolizumab combined with bevacizumab and RP2 and the second cohort with atezolizumab and bevacizumab and RP3. The Company believes that data with both RP2 and RP3 in CRC will allow the comparative efficacy of RP2 and RP3 to be evaluated in a particularly difficult to treat patient population. This clinical trial has now been initiated.
    • RP3 in combination with atezolizumab and bevacizumab in first (1L) and second-line (2L) hepatocellular carcinoma (HCC)
      • Two signal finding cohorts of 30 patients each will be enrolled in collaboration with Roche. The first cohort will enroll 1L patients treated with SOC atezolizumab combined with bevacizumab and RP3, and the second cohort will enroll patients who have progressed on 1L immunotherapy (including atezolizumab/bevacizumab), and will be treated with atezolizumab combined with bevacizumab and RP3. This clinical trial is expected to initiate this quarter.
    • RP3 in combination with standard of care therapy in squamous cell carcinoma of the head and neck (SCCHN)
      • A two-cohort clinical trial is planned, with the first cohort of 100 patients with locally advanced disease being randomized to receive either standard of care (SOC) cisplatin chemotherapy combined with radiation or RP3 combined with chemotherapy and radiation followed by adjuvant nivolumab therapy. The second, signal finding cohort, will enroll 30 patients with recurrent or metastatic SCCHN with low PDL1 levels (CPS