Replimune(US:REPL)2020-01-15 23:11Replimune's Immulytic Platform - The platform is designed to maximally activate the immune system against a patient's cancer, aiming to establish Replimune's products as the second cornerstone of immuno-oncology[4] - RP1 is in multiple clinical trials, focusing on immuno-responsive tumors, with potential registration clinical trials underway or to initiate in the first half of the year[4] - RP2 & RP3 are intended to treat less immuno-responsive tumors, with RP3 expected to enter the clinic in 2020[4] - The company had approximately $183 million in cash as of December 31, ensuring they are well-capitalized to deliver on their plans[4] Clinical Data and Trials - A randomized controlled phase 2 study of T-VEC + ipilimumab vs ipilimumab alone in advanced melanoma showed more than doubled response rates in combination (38% vs 18%)[14] - A T-VEC+pembrolizumab ph1b study showed a 67% response rate and a 43% CR rate[14] - A registration-directed randomized controlled Phase 2 trial in CSCC involves 240 patients randomized 2:1 (RP1+ cemiplimab vs cemiplimab alone)[24] - A 30 patient clinical trial of single agent RP1 is being conducted in solid organ transplant recipients with CSCC[24] - Approximately half of advanced melanoma patients still die of their disease, despite multiple approved therapies, leading to a focus on patients with primary resistance to anti-PD1 therapy[26] Manufacturing and Future Plans - The company has leased a 63,000 ft2 manufacturing facility in Framingham, MA, expected to be online to produce clinical product in 2020[58] - ~$183 million in cash at December 31, 2019 will be sufficient to fund its operating expenses into the 2H 2022[60]