Business
Replimune Provides 2021 Year End Review and Overview of Expected 2022 Milestones
CERPASS clinical trial with RP1 in CSCC on track to complete enrollment mid-year with the primary analysis trigger six months thereafter IGNYTE anti-PD1
About this update from Replimune Group, Inc.
[{"type":"text","content":"CERPASS clinical trial with RP1 in CSCC on track to complete enrollment mid-year with the primary analysis trigger six months thereafter IGNYTE anti-PD1 failed melanoma, evaluating RP1 in combination with Opdivo® on track to release interim data in late 2022 Phase 2 development plan for RP2/3 to be presented in the first quarter of 2022 Replimune to provide corporate update at the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022 WOBURN, Mass., Jan. 10, 2022 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, today provided a corporate update, highlighting the progress of key programs. “Data with RP1 in various high-value skin cancer indications has continued to mature in 2021,” said Philip Astley-Sparke, Chief Executive Officer of Replimune. “We have been thrilled to see the clear trends in safety and efficacy persist, with durability data that suggests RP1 has the profile to provide many patients with transformative long-term benefit. With our objective of establishing a broad skin cancer franchise with RP1, which has progressed to commercial planning, we have begun to validate the potential of our RP2 and RP3 oncolytic immunotherapies beyond skin cancers, including in tumor types that commonly metastasize to the liver. Replimune continues to build towards an exciting, data rich 2022, beginning later this quarter with a number of clinical updates, and visibility into the RP2/RP3 Phase 2 clinical development strategy.” Anticipated Key Milestones for 2022 CERPASS – Registration-directed Phase 2 clinical trial in cutaneous squamous cell carcinoma (CSCC) RP1 in combination with Libtayo® (cemiplimab-rwlc) in CSCC: The Company is actively enrolling patients in a registration-directed, global, randomized, controlled, 180-patient Phase 2 clinical trial (CERPASS) evaluating RP1 in combination with Libtayo vs. Libtayo alone in patients with advanced CSCC. The Company expects to complete enrollment such that the trigger for the primary data analysis is expected in late 2022. IGNYTE – Multi-cohort Phase 2 clinical trial of RP1 combined with Opdivo® (nivolumab) Anti-PD-1 failed melanoma cohort: The Company continues to enroll patients in the 125-patient cohort of the IGNYTE Phase 2 clinical t...