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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:
    20d
    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
    4ms
    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
    7ms
    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)
    8ms
    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)
    11ms
    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)
    over1year
    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
    over1year
    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)
    almost2years
    Wild-Type Reovirus in Combination With Carfilzomib and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=12, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2023 --> Nov 2024
    Trial completion date • Combination therapy
    |
    carfilzomib • Reolysin (pelareorep) • Hemady (dexamethasone tablets) • dexamethasone injection
    almost2years
    CEACAM6 and IFITM3 as potential biomarkers for pelareorep in pancreatic adenocarcinoma (PDAC). (ASCO-GI 2024)
    We previously performed a phase II trial of P with carboplatin (C) and paclitaxel (Pxl) vs C and Pxl alone in metastatic PDAC (NCT01280058). High CEACAM6 and IFITM3 play a role in P viral infectivity across multiple pancreatic cell lines, confirming results obtained in translational datasets. Further analysis is ongoing to elucidate mechanism and identify pathways to alter expression of CEACAM6 and IFITM3 and enhance P infectivity in future trials.
    CEACAM5 (CEA Cell Adhesion Molecule 5) • CEACAM6 (CEA Cell Adhesion Molecule 6)
    |
    CEACAM6 overexpression
    |
    carboplatin • paclitaxel • Reolysin (pelareorep)
    2years
    Pelareorep and Paclitaxel Injection in Chinese Patients With Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=15, Completed, Adlai Nortye Biopharma Co., Ltd. | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 overexpression
    |
    paclitaxel • Reolysin (pelareorep)
    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 completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Jun 2023 --> Jan 2024
    Trial completion date • 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)
    2years
    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 | Phase classification: P1b/2 --> P1/2
    Phase classification • Combination therapy
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • GZMB (Granzyme B)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • bortezomib • Reolysin (pelareorep) • Hemady (dexamethasone tablets) • dexamethasone injection