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    DRUG:

    RP3

    i
    Other names: RP3, genetically modified HSV-1, genetically modified herpes simplex type 1 virus
    Associations

    News

    Trials
    Company:
    Replimune
    Drug class:
    CTLA4 inhibitor, CD137 modulator, CD40 stimulant
    Related drugs:
    Associations

    News

    Trials
    4ms
    Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours (clinicaltrials.gov)
    P1, N=123, Active, not recruiting, Replimune Inc. | Trial completion date: Apr 2024 --> Nov 2026 | Trial primary completion date: Apr 2024 --> Nov 2026
    Trial completion date • Trial primary completion date • Combination therapy
    |
    Opdivo (nivolumab) • RP3
    8ms
    RP2/RP3 in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With CRC (clinicaltrials.gov)
    P2, N=4, Active, not recruiting, Replimune Inc. | N=60 --> 4
    Enrollment change • Combination therapy • Oncolytic virus • Mismatch repair • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • RP3
    11ms
    Study of RP3 in Combination With Nivolumab and Other Therapy in Patients With Locoregionally Advanced or Recurrent SCCHN (clinicaltrials.gov)
    P2, N=0, Withdrawn, Replimune Inc. | N=130 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • Combination therapy • Oncolytic virus • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    CDKN2A negative
    |
    Opdivo (nivolumab) • carboplatin • paclitaxel • RP3
    11ms
    RP2/RP3 in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With CRC (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, Replimune Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Oncolytic virus • Mismatch repair • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • RP3
    11ms
    RP3 in Combination With 1L or 2L Therapy in Patients With Locally Advanced Unresectable or Metastatic HCC (clinicaltrials.gov)
    P2 | N=60 | Not yet recruiting | Sponsor: Replimune Inc. | Trial primary completion date: Jan 2027 ➔ Apr 2027
    Oncolytic virus • Combination therapy • Trial primary completion date
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP3
    11ms
    Study of RP3 Monotherapy and RP3 in Combination With Nivolumab in Patients With Solid Tumours (clinicaltrials.gov)
    P1, N=123, Active, not recruiting, Replimune Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    Opdivo (nivolumab) • RP3
    12ms
    An open-label clinical trial of RP2 and RP3 oncolytic immunotherapy in combination with atezolizumab plus bevacizumab for the treatment of patients with advanced colorectal carcinoma. (ASCO-GI 2024)
    Safety will be assessed by physical examination, clinical laboratory evaluations, vital signs, and monitoring for adverse events (AEs; including serious AEs). Clinical trial information: NCT05733611.
    Clinical • Combination therapy • Oncolytic virus • Metastases
    |
    MSI (Microsatellite instability) • CD40 (CD40 Molecule)
    |
    MSI-H/dMMR • CSF2 expression
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • RP3
    1year
    RP3 in Combination With 1L or 2L Therapy in Patients With Locally Advanced Unresectable or Metastatic HCC (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Replimune Inc. | Initiation date: Oct 2023 --> Feb 2024
    Trial initiation date • Combination therapy • Oncolytic virus • Metastases
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP3
    1year
    Study of RP3 in Combination With Nivolumab and Other Therapy in Patients With Locoregionally Advanced or Recurrent SCCHN (clinicaltrials.gov)
    P2, N=130, Not yet recruiting, Replimune Inc. | Initiation date: Sep 2023 --> Jan 2024
    Trial initiation date • Combination therapy • Oncolytic virus • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    CDKN2A negative
    |
    Opdivo (nivolumab) • carboplatin • paclitaxel • RP3
    over1year
    Study of RP3 in Combination With Nivolumab and Other Therapy in Patients With Locoregionally Advanced or Recurrent SCCHN (clinicaltrials.gov)
    P2, N=130, Not yet recruiting, Replimune Inc. | Initiation date: Jun 2023 --> Sep 2023
    Trial initiation date • Combination therapy • Oncolytic virus • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    CDKN2A negative
    |
    Opdivo (nivolumab) • carboplatin • paclitaxel • RP3
    over1year
    RP2/RP3 in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With CRC (clinicaltrials.gov)
    P2, N=60, Recruiting, Replimune Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Oncolytic virus • Mismatch repair • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • RP3
    over1year
    RP3 in Combination With 1L or 2L Therapy in Patients With Locally Advanced Unresectable or Metastatic HCC (clinicaltrials.gov)
    P2 | N=60 | Not yet recruiting | Sponsor: Replimune Inc. | Initiation date: Jun 2023 ➔ Sep 2023
    Oncolytic virus • Combination therapy • Trial initiation date
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP3
    over1year
    An ongoing open-label, phase 2 trial of RP2 Or RP3 oncolytic immunotherapy in combination with atezolizumab and bevacizumab for the treatment of patients with advanced colorectal carcinoma (ESMO-GI 2023)
    AE severity will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.Clinical trial identification: NCT05733611.Editorial acknowledgement: Medical writing and editorial support were provided by Marita Chakhtoura, PhD, of AlphaBioCom, LLC, a Red Nucleus Company (King of Prussia, PA, USA) and were funded by Replimune Inc. (Woburn, MA, USA).Legal entity responsible for the study: Replimune Inc.
    Clinical • P2 data • Combination therapy • Oncolytic virus • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    MSI (Microsatellite instability) • CD40 (CD40 Molecule)
    |
    MSI-H/dMMR • CSF2 expression
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • RP3
    over1year
    Trial in progress: An open-label, multicenter study investigating RP3 oncolytic immunotherapy in combination with first- or second-line systemic atezolizumab and bevacizumab in locally advanced unresectable or metastatic hepatocellular carcinoma (LCS 2023)
    The primary endpoint is overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints are safety, ORR using HCC modified RECIST, duration of response, complete response rate, and progression-free survival.
    Clinical • Combination therapy • Oncolytic virus • Metastases
    |
    CD40LG (CD40 ligand)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP3
    over1year
    Preclinical characterization and clinical biomarker studies with RP3, a novel oncolytic immunotherapy expressing a fusogenic protein, a human anti-CTLA-4 antibody, hCD40L and h4-1BBL (AACR 2023)
    Preclinical experiments from mice models confirmed the robust expression of CD40-L, 4-1BBL and anti-CTLA-4 in RP3-injected tumors. Biomarker studies from patients demonstrate increases in CD8-T cell infiltration and PD-L1 expression post RP3 +/- nivolumab treatment, including increases in the expression of genes associated with response to anti-PD-1 therapy. These data indicate the potential for broad utility of RP3 in a range of tumor types, including in tumors that are not sensitive to PD-1 blockade.
    Preclinical • Oncolytic virus • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CD40LG (CD40 ligand) • CD86 (CD86 Molecule)
    |
    PD-L1 expression • BRAF V600E • BRAF V600
    |
    Opdivo (nivolumab) • RP3
    over1year
    Study of RP3 in Combination With Nivolumab and Other Therapy in Patients With Locoregionally Advanced or Recurrent SCCHN (clinicaltrials.gov)
    P2, N=130, Not yet recruiting, Replimune Inc.
    New P2 trial • Combination therapy • Oncolytic virus • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    CDKN2A negative
    |
    Opdivo (nivolumab) • carboplatin • paclitaxel • RP3
    almost2years
    RP3 in Combination With 1L or 2L Therapy in Patients With Locally Advanced Unresectable or Metastatic HCC (clinicaltrials.gov)
    P2 | N=60 | Not yet recruiting | Sponsor: Replimune Inc.
    Oncolytic virus • Combination therapy • New P2 trial
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP3
    almost2years
    RP2/RP3 in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With CRC (clinicaltrials.gov)
    P2 | N=60 | Not yet recruiting | Sponsor: Replimune Inc.
    Oncolytic virus • Combination therapy • New P2 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • RP2 • RP3