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    DRUG:

    mRNA-2752

    i
    Other names: mRNA-2752, mRNA2752, mRNA 2752
    Associations

    News

    Trials
    Company:
    Moderna
    Drug class:
    IL-23 modulator, IL-36γ modulator, OX40 ligand modulator
    Related drugs:
    Associations

    News

    Trials
    4ms
    mRNA-2752-P101: Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Malignancies (clinicaltrials.gov)
    P1, N=134, Completed, ModernaTX, Inc. | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> Aug 2025 | Trial primary completion date: Dec 2025 --> Aug 2025
    Trial completion • Trial completion date • Trial primary completion date • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    PD-L1 negative • BRAF wild-type
    |
    Imfinzi (durvalumab) • mRNA-2752
    11ms
    Immunotherapy in High-risk Ductal Carcinoma in Situ (DCIS) (clinicaltrials.gov)
    P1, N=42, Active, not recruiting, Laura Esserman | Trial primary completion date: Mar 2025 --> Mar 2026 | Recruiting --> Active, not recruiting | N=68 --> 42 | Trial completion date: Mar 2025 --> Mar 2026
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Keytruda (pembrolizumab) • mRNA-2752
    11ms
    Intratumoral Injection of mRNA-2752 and Pembrolizumab for High-Risk Ductal Carcinoma In Situ: A Phase 1 Nonrandomized Clinical Trial. (PubMed, JAMA Oncol)
    These findings warrant additional investigation, and studies are ongoing. ClinicalTrials.gov Identifier: NCT02872025.
    Clinical • P1 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • TNFSF4 (TNF Superfamily Member 4)
    |
    HER-2 positive • HR positive • HER-2 negative
    |
    Keytruda (pembrolizumab) • mRNA-2752
    over1year
    Immunotherapy in High-risk Ductal Carcinoma in Situ (DCIS) (clinicaltrials.gov)
    P1, N=68, Recruiting, Laura Esserman | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Keytruda (pembrolizumab) • mRNA-2752
    over1year
    Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Malignancies (clinicaltrials.gov)
    P1, N=134, Active, not recruiting, ModernaTX, Inc. | Trial completion date: Apr 2025 --> Mar 2026 | Trial primary completion date: May 2024 --> Mar 2026
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Checkpoint block • Metastases • Lipid Nanoparticle
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    PD-L1 negative • BRAF wild-type
    |
    Imfinzi (durvalumab) • mRNA-2752
    almost2years
    Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Malignancies (clinicaltrials.gov)
    P1, N=134, Active, not recruiting, ModernaTX, Inc. | Recruiting --> Active, not recruiting | N=264 --> 134
    Enrollment closed • Enrollment change
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    PD-L1 negative • BRAF wild-type
    |
    Imfinzi (durvalumab) • mRNA-2752
    almost3years
    Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Malignancies (clinicaltrials.gov)
    P1, N=264, Recruiting, ModernaTX, Inc. | Trial completion date: Jan 2023 --> Apr 2025 | Trial primary completion date: Jan 2023 --> May 2024
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Checkpoint block • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    PD-L1 negative • BRAF wild-type
    |
    Imfinzi (durvalumab) • mRNA-2752
    3years
    Safety and Preliminary Efficacy of mRNA-2752, a Lipid Nanoparticle Encapsulating mRNAs Encoding Human OX40L/IL-23/IL-36γ for Intratumoral (ITu) Injection, and durvalumab (IV) in TNBC, HNSCC, and Melanoma (SITC 2022)
    Biomarker analyses indicate mRNA-2752 drives cytokine responses. Consistent with the expected mechanism of action, a productive and sustained inflammatory response is observed in the TME in response to treatment, including signatures of increased innate and adaptive immune cell abundance and effector response.
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha) • IL23A (Interleukin 23 Subunit Alpha)
    |
    PD-L1 underexpression
    |
    Imfinzi (durvalumab) • mRNA-2752
    4years
    Dose Escalation Study of mRNA-2752 for Intratumoral Injection to Participants in Advanced Malignancies (clinicaltrials.gov)
    P1, N=264, Recruiting, ModernaTX, Inc. | N=126 --> 264 | Trial completion date: Jul 2021 --> Jan 2023 | Trial primary completion date: Jul 2021 --> Jan 2023
    Clinical • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF wild-type
    |
    Imfinzi (durvalumab) • mRNA-2752
    over5years
    [VIRTUAL] A phase I study of mRNA-2752, a lipid nanoparticle encapsulating mRNAs encoding human OX40L, IL-23, and IL-36γ, for intratumoral (iTu) injection alone and in combination with durvalumab. (ASCO 2020)
    iTu mRNA-2752 given as monotherapy and in combination with durva is tolerable at all dose levels studied, and administration can be associated with tumor shrinkage. Analyses of tumor and plasma biomarkers suggest a sustained immunomodulatory effect of treatment that includes elevated IFN-γ, TNF-α, and PD-L1 levels. These data support the ongoing testing of the mRNA-2752/durva combination in the dose escalation part of the study.
    P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6)
    |
    PD-L1 expression
    |
    Imfinzi (durvalumab) • mRNA-2752