On October 24, 2019 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported that the company has enrolled the first patient in its Phase 1 clinical trial of RP2 (Press release, Replimune, OCT 24, 2019, View Source [SID1234542485]). RP2 expresses a genetically encoded anti-CTLA-4 antibody-like molecule, in addition to GALV-GP-R- and GM-CSF, both of which are expressed in Replimune’s first product candidate, RP1. This is intended to block the inhibition of the initiation of immune responses caused by CTLA-4.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are excited to be advancing RP2, our second novel Immulytic product candidate, into clinical studies," said Robert Coffin, Ph.D., co-founder, President and CEO of Replimune. "CTLA-4 inhibition is an established mechanism of action for cancer treatment, including proven synergy with anti-PD1 therapy. By combining the expression of anti-CTLA-4 with oncolytic tumor destruction and antigen release directly in the tumor and draining lymph nodes, we believe that the efficacy of CTLA-4 inhibition can be enhanced with RP2, while reducing toxicity as compared to systemic administration."
The Phase 1 clinical trial will study RP2 as a single agent and in combination with Opdivo (nivolumab) in patients with advanced solid tumors. The Phase 1 clinical trial is designed to assess the safety, tolerability and to determine the optimal dose of RP2 alone and in combination with anti-PD1 therapy and is being conducted as a collaboration with Bristol-Myers Squibb Company (BMS). BMS has granted Replimune a nonexclusive, non-transferable, royalty-free license to, and will supply at no cost, Opdivo, for use in combination with RP2. BMS has no further development-related obligations under this collaboration.
About RP2
RP2 is Replimune’s second Immulytic product candidate and like RP1, is based on a proprietary new strain of herpes simplex virus which expresses GM-CSF and the fusogenic protein GALV-GP R-. In addition to the properties of RP1, RP2 expresses an anti-CTLA-4 antibody-like protein in order to block the inhibition of the immune response otherwise caused by CTLA-4. In preclinical studies comparing RP1 to RP2 to determine the effect of expressing anti-CTLA-4, RP2 demonstrated enhanced efficacy both alone and in combination with anti-PD1 therapy both in tumors which were injected with RP1 or RP2 and in tumors which were left uninjected