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    DRUG:

    Reolysin (pelareorep)

    i
    Other names: reovirus serotype 3, respiratory enteric orphan virus, PO-BB0209, RT3D, AN1004, AN 1004, AN-1004, POBB0209, POBB 0209, PO BB0209
    Company:
    Adlai Nortye, Oncolytics
    Drug class:
    Apoptosis stimulant
    Related drugs:
    23d
    GOBLET: A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab (clinicaltrials.gov)
    P1/2, N=122, Active, not recruiting, Oncolytics Biotech | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    PD-L1 (Programmed death ligand 1)
    |
    Tecentriq (atezolizumab) • gemcitabine • albumin-bound paclitaxel • oxaliplatin • irinotecan • Lonsurf (trifluridine/tipiracil) • Reolysin (pelareorep)
    28d
    Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AMBUSH Trial (clinicaltrials.gov)
    P1/2, N=10, Active, not recruiting, University of Southern California | Trial primary completion date: Aug 2026 --> Dec 2026
    Trial primary completion date
    |
    Keytruda (pembrolizumab) • bortezomib • Reolysin (pelareorep) • Hemady (dexamethasone tablets) • dexamethasone injection
    2ms
    FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer (clinicaltrials.gov)
    P2, N=60, Recruiting, Oncolytics Biotech | Not yet recruiting --> Recruiting
    Enrollment open
    |
    MSI (Microsatellite instability)
    |
    RAS mutation
    |
    Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • Reolysin (pelareorep)
    3ms
    FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Oncolytics Biotech
    New P2 trial
    |
    MSI (Microsatellite instability)
    |
    RAS mutation
    |
    Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • Reolysin (pelareorep)
    6ms
    GOBLET: A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab (clinicaltrials.gov)
    P1/2, N=122, Recruiting, Oncolytics Biotech
    New P1/2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Tecentriq (atezolizumab) • gemcitabine • albumin-bound paclitaxel • oxaliplatin • irinotecan • Lonsurf (trifluridine/tipiracil) • Reolysin (pelareorep)
    7ms
    Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AMBUSH Trial (clinicaltrials.gov)
    P1/2, N=10, Active, not recruiting, University of Southern California | Recruiting --> Active, not recruiting | N=42 --> 10
    Enrollment closed • Enrollment change
    |
    Keytruda (pembrolizumab) • bortezomib • Reolysin (pelareorep) • Hemady (dexamethasone tablets) • dexamethasone injection
    10ms
    Bortezomib and Pembrolizumab With or Without Pelareorep for the Treatment of Relapsed or Refractory Multiple Myeloma, AMBUSH Trial (clinicaltrials.gov)
    P1/2, N=42, Recruiting, University of Southern California | Trial completion date: Oct 2026 --> Oct 2027 | Trial primary completion date: Oct 2025 --> Oct 2026
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • bortezomib • Reolysin (pelareorep) • Hemady (dexamethasone tablets) • dexamethasone injection
    1year
    A Phase II Randomized Study of Paclitaxel alone or combined with Pelareorep with or without Avelumab in Metastatic Hormone Receptor Positive Breast Cancer: the BRACELET-01/PrE0113 study. (PubMed, Clin Cancer Res)
    The addition of Pel to Pac was associated with increased toxicity, expanded peripheral T-cell clones, and numerically increased ORR and PFS compared to Pac; Pac/Pel/Ave further increased toxicity and blunted T cell responses without obvious increase in efficacy. Investigation of the Pac/Pel combination warrants consideration with careful attention to acute toxicity.
    P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    PD-L1 expression • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    paclitaxel • Bavencio (avelumab) • Reolysin (pelareorep)
    1year
    INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study (clinicaltrials.gov)
    P2, N=25, Active, not recruiting, Mridula George, MD | Recruiting --> Active, not recruiting | Trial completion date: Sep 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 expression
    |
    Irene (pyrotinib) • Zynyz (retifanlimab-dlwr) • Reolysin (pelareorep)
    over1year
    A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study (clinicaltrials.gov)
    P2, N=48, Active, not recruiting, Oncolytics Biotech | Trial completion date: Jul 2024 --> Jun 2025
    Trial completion date
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 overexpression
    |
    paclitaxel • Bavencio (avelumab) • Reolysin (pelareorep)
    2years
    Wild-Type Reovirus in Combination With Carfilzomib and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=12, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Nov 2024 --> May 2024
    Trial completion • Trial completion date • Combination therapy
    |
    carfilzomib • Reolysin (pelareorep) • Hemady (dexamethasone tablets) • dexamethasone injection
    2years
    NCI-2020-02940: INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study (clinicaltrials.gov)
    P2, N=25, Recruiting, Mridula George, MD | Trial primary completion date: Jan 2024 --> Jun 2024
    Trial primary completion date • Oncolytic virus • IO biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    PD-L1 expression • HER-2 expression • ER expression
    |
    Irene (pyrotinib) • Zynyz (retifanlimab-dlwr) • Reolysin (pelareorep)