On May 26, 2022 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, reported multiple presentations at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, IL from June 3 to June 7, 2022 (Press release, Replimune, MAY 26, 2022, View Source [SID1234615099]).
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Details for the presentations are as follows:
Data presentation
Updated results from the skin cancer cohorts from an ongoing Phase 1/2 multi-cohort study of RP1, an enhanced potency oncolytic HSV, combined with nivolumab (IGNYTE)
Session Title: Melanoma/Skin Cancers
Session Date and Time: Monday, June 6, 2022, 1:15 PM-4:15 PM CDT
Location: McCormick Place, Exhibit Hall A, Poster 146
Abstract: 9553
Trial in progress presentations
A randomized, controlled, open-label, phase 2 study of cemiplimab ± RP1 in patients with advanced cutaneous squamous cell carcinoma (CERPASS)
Session Title: Melanoma/Skin Cancers
Session Date and Time: Monday, June 6, 2022, 1:15 PM-4:15 PM CDT
Location: McCormick Place, Exhibit Hall A, Poster 184a
Abstract: TPS9593
An open-label, multicenter, phase 1b/2 study of RP1, a first-in-class, enhanced potency oncolytic virus in solid organ transplant recipients with advanced cutaneous malignancies (ARTACUS)
Session Title: Melanoma/Skin Cancers
Session Date and Time: Monday, June 6, 2022, 1:15 PM-4:15 PM CDT
Location: McCormick Place, Exhibit Hall A, Poster 187a
Abstract: TPS9597
A phase 1 trial of RP2, a first-in-class, enhanced potency oncolytic HSV expressing an anti-CTLA-4 antibody as a single agent and combined with nivolumab in patients with advanced solid tumors
Session Title: Developmental Therapeutics Immunotherapy
Session Date and Time: Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT
Location: McCormick Place, Exhibit Hall A, Poster 339b
Abstract: TPS2704
An open-label, multicenter, phase 1 study of RP3 as a single agent and in combination with nivolumab in patients (pts) with solid tumors
Session Title: Developmental Therapeutics Immunotherapy
Session Date and Time: Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT
Location: McCormick Place, Exhibit Hall A, Poster 340a
Abstract: TPS2705
About CERPASS
CERPASS is Replimune’s registration-directed randomized, global Phase 2 clinical study to compare the effects of Libtayo alone versus a combination of Libtayo and Replimune’s investigational oncolytic immunotherapy RP1. The clinical trial is enrolling 180 patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are naïve to anti-PD-1 therapy. The clinical trial will evaluate complete response (CR) rate and overall response rate (ORR) as its two primary efficacy endpoints as assessed by independent review, as well as duration of response, progression-free survival (PFS), and overall survival (OS) as secondary endpoints. The study is being conducted under a clinical trial collaboration agreement with Regeneron in which the costs of the trial are shared and full commercial rights retained by Replimune. Libtayo is being jointly developed by Regeneron and Sanofi.
Libtayo is a registered trademark of Regeneron.
About IGNYTE
IGNYTE is Replimune’s multi-cohort Phase 1/2 trial of RP1 plus Opdivo. There are 4 tumor specific cohorts currently enrolling in this clinical trial including a 125-patient cohort in anti-PD-1 failed cutaneous melanoma. This cohort was initiated after completing enrollment in a prior Phase 2 cohort in the same clinical trial of approximately 30 patients with melanoma. The additional cohorts are in non-melanoma skin cancers which includes both naïve and anti-PD-1 failed CSCC, in anti-PD1 failed microsatellite instability high, or MSI-H/dMMR tumors and anti-PD(L)-1 failed non-small cell lung cancer, or NSCLC. This trial is being conducted under a collaboration and supply agreement with Bristol-Myers Squibb Company. Opdivo is a registered trademark of Bristol-Myers Squibb Company.
About RP1
RP1 is Replimune’s lead product candidate and is based on a proprietary new strain of herpes simplex virus engineered and genetically armed to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.
About RP2 & RP3
RP2 and RP3 are derivatives of RP1 that express additional immune-activating proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses the immune co-stimulatory pathway activating proteins CD40L and 4-1BBL. RP2 and RP3 are intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic immune-based efficacy on tumors and limiting off-target toxicity.