Company Overview - Replimune, founded in 2015 by the ex-BioVex management team, focuses on developing "armed" oncolytic immunotherapy [4] - The company's lead product candidate, RP1, is intended to enter a registration-directed Phase 2 clinical trial in cutaneous squamous cell carcinoma (CSCC) in H1 2019 with approximately 240 patients [44, 58, 60] - Replimune had a cash balance of $147.9 million as of September 30th, 2018 [4] Technology and Pipeline - The company's platform uses HSV (Herpes Simplex Virus) to selectively replicate in and kill tumors, activating both innate and adaptive immunity [12, 21] - RP1 is being studied in an ongoing Phase 1/2 clinical trial with approximately 150 patients in combination with nivolumab across four tumor types [4, 41, 60] - RP2 and RP3, designed for PD-1/L1 non-responsive tumors, are expected to enter clinical development in 2019 and 2020, respectively [53, 59, 60] Clinical Trials and Collaborations - A randomized, controlled Phase 2 clinical trial in CSCC with approximately 240 patients will compare RP1+ cemiplimab vs cemiplimab alone [42, 44, 60] - Replimune has a clinical trial collaboration with BMS for the supply of nivolumab in an ongoing ≈150 patient Phase 1/2 trial [4, 41, 60] - The company also has a collaboration with Regeneron, involving 50:50 cost sharing and cemiplimab supply, for a randomized controlled Phase 2 trial with approximately 240 patients starting in H1 2019 [4, 42, 44, 60]
Replimune Group (REPL) Presents At 37th Annual J.P. Morgan Healthcare Conference - Slideshow