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    DRUG:

    mRNA-2416

    i
    Other names: mRNA-2416, mRNA 2416
    Associations

    News

    Trials
    Company:
    Moderna
    Drug class:
    OX40 ligand modulator
    Related drugs:
    Associations

    News

    Trials
    8ms
    First-in-human phase I/II, open-label study of mRNA-2416 alone or combined with durvalumab in patients with advanced solid tumors and ovarian cancer. (PubMed, Oncologist)
    mRNA-2416 alone or with durvalumab was well tolerated. Pharmacodynamic analyses support Itu mRNA proof-of-concept. Predefined primary efficacy endpoints were not met in an exploratory cohort of ovarian cancer. Additional research is warranted to further inform this therapeutic approach.
    Clinical • P1/2 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • TNFSF4 (TNF Superfamily Member 4)
    |
    PD-L1 expression
    |
    Imfinzi (durvalumab) • mRNA-2416
    over3years
    Dose Escalation and Efficacy Study of mRNA-2416 for Intratumoral Injection Alone and in Combination With Durvalumab for Participants With Advanced Malignancies (clinicaltrials.gov)
    P1/2, N=79, Terminated, ModernaTX, Inc. | N=117 --> 79 | Trial completion date: Sep 2022 --> Aug 2021 | Active, not recruiting --> Terminated | Trial primary completion date: Sep 2022 --> Aug 2021; This study was halted prematurely because the efficacy endpoints were not met for either treatment arm.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    Imfinzi (durvalumab) • mRNA-2416
    over4years
    Spatial mapping and immunomodulatory role of the OX40/OX40L pathway in human non-small cell lung cancer. (PubMed, Clin Cancer Res)
    The OX40 pathway is expressed in a fraction of NSCLCs and is associated with a favorable immune contexture. Although OX40L is uncommonly expressed in NSCLC and serous malignancies, it is associated with better prognosis and can be introduced using exogenous mRNA.
    Journal • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    KRAS mutation • EGFR mutation • TNFRSF4 expression
    |
    mRNA-2416
    over4years
    Dose Escalation and Efficacy Study of mRNA-2416 for Intratumoral Injection Alone and in Combination With Durvalumab for Participants With Advanced Malignancies (clinicaltrials.gov)
    P1/2, N=117, Active, not recruiting, ModernaTX, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Sep 2022 | Trial primary completion date: Mar 2023 --> Sep 2022
    Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    Imfinzi (durvalumab) • mRNA-2416
    almost5years
    Dose Escalation and Efficacy Study of mRNA-2416 for Intratumoral Injection Alone and in Combination With Durvalumab for Participants With Advanced Malignancies (clinicaltrials.gov)
    P1/2, N=117, Recruiting, ModernaTX, Inc. | Trial completion date: Mar 2022 --> Mar 2023 | Trial primary completion date: Sep 2021 --> Mar 2023
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    Imfinzi (durvalumab) • mRNA-2416
    almost6years
    Durable anticancer immunity from intratumoral administration of IL-23, IL-36γ, and OX40L mRNAs. (PubMed, Sci Transl Med)
    Last, combining triplet mRNA with checkpoint blockade led to efficacy in models otherwise resistant to systemic immune checkpoint inhibition. Human cell studies showed similar cytokine responses to the individual components of this mRNA mixture, suggesting translatability of immunomodulatory activity to human patients.
    Journal
    |
    CD8 (cluster of differentiation 8)
    |
    mRNA-2416