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Replimune Announces Presentation at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting
Initial safety and efficacy data from the single agent RP2 portion of the Phase 1 clinical trial of RP2 alone & in combination with Opdivo® (nivolumab) in
About this update from Replimune Group, Inc.
[{"type":"text","content":"Initial safety and efficacy data from the single agent RP2 portion of the Phase 1 clinical trial of RP2 alone & in combination with Opdivo® (nivolumab) in patients with solid tumors\n An update from the melanoma & non-melanoma skin cancer patients enrolled into the Phase 1/2 clinical trial of RP1 in combination with Opdivo® (nivolumab) WOBURN, Mass., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic™ platform, announced that data with the Company’s lead product candidate, RP1, along with initial single agent safety and efficacy data with RP2 in advanced solid tumors, will be presented at the Society for Immunotherapy of Cancer (SITC) annual meeting being held virtually from November 9-14, 2020. The abstracts for these presentations appeared briefly and in error on the SITC website this morning, prior to their intended release on November 9th 2020, and as a result are provided in full below. Details of Replimune’s poster presentations: Title: (647) Initial results of a phase 1 trial of RP2, a first in class, enhanced potency, anti-CTLA-4 antibody expressing, oncolytic HSV as single agent and combined with nivolumab in patients with solid tumors Abstract Authors: Mark Middleton, Joseph J. Sacco, Kevin Harrington, Anna Olsson-Brown, Pablo Nenclares, Francesca Aroldi, Suzanne Thomas, Robert S. Coffin, etc. Presentation times: Wednesday, Nov. 11 from 5:15–5:45 p.m. EST and Friday, Nov. 13 from 4:40–5:10 p.m. EST Location: Virtual Poster Hall Full abstract: Background: RP2 is an enhanced potency oncolytic HSV-1 expressing granulocytemacrophage colony-stimulating factor (GM-CSF), a fusogenic protein (GALVGP R-), and an anti-cytotoxic T lymphocyte antigen 4 (CTLA-4) antibody-like molecule which is being tested in an open-label, multicenter, phase 1 study alone and combined with PD-1 blockade (NCT04336241). Methods: The objectives were to assess initial safety and efficacy and determine the recommended phase 2 dose (RP2D) of RP2 alone and combined with nivolumab. Patients were to be treated using a 3+3 dose escalation at two dose levels of up to 10mL of RP2 Q2W up to 5 times (dose level 1: 105 PFU/mL then 4 doses of 106 PFU/mL; dose level 2: 106 PFU/mL then 4 doses of 107 PFU/mL). Following determination of the RP2D, additio...