Replimune Group announces updates on RP2/3 data, development plans

Replimune Group announced an RP2/3 data updates and development plans. RP2/3 Clinical Update and Development Plan: The Company is pursuing a Phase 2 development plan for RP2 and RP3 targeting tumor types in large and underserved markets, including where liver metastases are common, as well as patients with primary liver cancer, and patients with earlier disease where the objective of treatment would be to achieve a cure. This includes the development of RP2/3 in combination with the current standard of care, including immunotherapy, chemotherapy and radiation, and in settings following the current SOC. RP2/3 Data Updates: The Company is today presenting updated data in uveal melanoma patients from the Phase 1 clinical trial evaluating RP2 in combination with nivolumab. Seventeen patients have been treated with RP2 as monotherapy or in combination with nivolumab to date. Four of the 14 patients which are so far evaluable have responded to treatment, 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. The Company is also presenting data from a Phase 1 clinical trial of RP3 in combination with nivolumab, in patients with soft tissue sarcomas. Five patients have been treated with RP3 combined with nivolumab in patients with multiple soft tissue sarcomas including in leiyomyosacoma, osteosarcoma, chondrosarcoma, and epithelioid sarcomas who have all have failed standard of care. Overall, RP2/3 continues to demonstrate promising early signals that could unlock additional opportunities in hard to treat cancers. RP2/3 Phase 2 Development Plans: Three Phase 2 clinical trials are to be conducted with RP2/3, each initiating in the first half of 2023. Squamous cell carcinoma of the head and neck: A two cohort clinical trial with RP3 will be conducted, with the first cohort of 100 patients with locally advanced disease being randomized to receive either SOC 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 who will be treated with chemotherapy, nivolumab and RP3. Hepatocellular carcinoma: Two 30 patient signal finding cohorts of patients will be enrolled. The first cohort of patients will enroll 1L patients treated with SOC atezolizumab combined with bevacizumab and RP3, and the second cohort of patients who have progressed on 1L immunotherapy also to be treated with atezolizumab combined with bevacizumab and RP3. Colorectal cancer: Two 30 patient 3L signal finding cohorts of patients will be enrolled. The first cohort will be treated with atezolizumab combined with bevacizumab and RP2 and the second cohort with RP3 combined with atezolizumab and bevacizumab.