On May 25, 2023 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 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, IL from June 2-6, 2023 (Press release, Replimune, MAY 25, 2023, View Source [SID1234632075]).
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Replimune has one abstract selected for a poster discussion session that will include updated results from the first 75 patients treated with RP1 combined with nivolumab from the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial. In addition, the Company will also present data from the Phase 1 trial of RP2 combined with nivolumab in uveal melanoma, and trial-in-progress posters from the RP2/3 programs.
Details for the presentations are as follows:
Data Presentations
Abstract Title: Initial efficacy and safety of RP1 + nivolumab in patients with anti–PD-1–failed melanoma from the ongoing phase 1/2 IGNYTE study
Poster Session Title: Melanoma/Skin Cancers
Poster Session Date and Time: Saturday, June 3, 2023, 1:15 PM-4:15 PM CDT
Poster Location: McCormick Place, Exhibit Hall A, Poster 272
Abstract: 9509
The IGNYTE poster will be discussed as part of a poster discussion session focused on melanoma/skin cancers on Saturday, June 3, 2023 at 4:30 pm CDT in S406 at McCormick Place.
Abstract Title: Preliminary safety and efficacy results from an open-label, multicenter, phase 1 study of RP2 as a single agent and in combination with nivolumab in a cohort of patients with uveal melanoma
Session Title: Melanoma/Skin Cancers
Session Date and Time: Saturday, June 3, 2023, 1:15 PM-4:15 PM CDT
Location: McCormick Place, Exhibit Hall A, Poster 290
Abstract: 9527
Trial-in-progress presentations
Abstract Title: A phase 2, open-label, multicenter study investigating efficacy and safety of RP3 oncolytic immunotherapy combined with other therapies in patients with locoregionally advanced or recurrent squamous cell carcinoma of the head and neck
Session Title: Head and Neck Cancer
Session Date and Time: Monday, June 5, 2023,1:15 PM-4:15 PM CDT
Location: McCormick Place, Exhibit Hall A, Poster 95b
Abstract: TPS6106
Abstract Title: An open-label clinical trial of RP2 and RP3 oncolytic immunotherapy in combination with atezolizumab and bevacizumab for the treatment of patients with advanced colorectal carcinoma
Session Title: Gastrointestinal Cancer—Colorectal and Anal
Session Date and Time: Monday, June 5, 2023, 8:00 AM-11:00 AM CDT
Location: McCormick Place, Exhibit Hall A, Poster 326a
Abstract: TPS3628
Abstract Title: An open-label, multicenter study investigating RP3 oncolytic immunotherapy in combination with first- or second-line systemic atezolizumab and bevacizumab therapy in patients with locally advanced unresectable or metastatic hepatocellular carcinoma
Session Title: Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date and Time: Monday, June 5, 2023, 8:00 AM-11:00 AM CDT
Location: McCormick Place, Exhibit Hall A, Poster 495b
Abstract: TPS4178
About IGNYTE
IGNYTE is Replimune’s multi-cohort Phase 1/2 trial of RP1 plus nivolumab. There are 3 tumor specific cohorts currently enrolling in this clinical trial including a 125-patient cohort in anti-PD1 failed melanoma with registrational intent. 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-PD1 failed CSCC, and in anti-PD1 failed microsatellite instability high, or MSI-H/dMMR tumors. This trial is being conducted under a collaboration and supply agreement with Bristol-Myers Squibb.
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 with a fusogenic protein (GALV-GP R-) and GM-CSF 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, but does not express GM-CSF. 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.