^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    OMO-103

    i
    Other names: OMO-103, Omomyc cell-penetrating peptide, OMO103
    Company:
    Peptomyc
    Drug class:
    MYC inhibitor
    Related drugs:
    17d
    The MYC network: Hub of malignancy and blueprint for intervention. (PubMed, Biochim Biophys Acta Rev Cancer)
    Recent clinical progress with Omomyc-derived OMO-103 and other MYC-network-targeting agents supports the feasibility of therapeutically intercepting this historically challenging pathway. However, because many MYC-directed strategies affect essential transcriptional, chromatin, and metabolic programs, future development will require careful biomarker selection, rational combinations, and rigorous evaluation of therapeutic windows. By integrating mechanistic and translational literature, this review highlights MYC as a dynamic cancer dependency and discusses opportunities for precision intervention.
    Review • Journal
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • MYCL (MYCL Proto-Oncogene BHLH Transcription Factor)
    |
    OMO-103
    4ms
    OMO-103 for the Treatment of Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1, N=12, Recruiting, OHSU Knight Cancer Institute | Not yet recruiting --> Recruiting | Initiation date: Aug 2025 --> Jan 2026
    Enrollment open • Trial initiation date
    |
    OMO-103
    6ms
    OMO-103-02: Study to Evaluate the Safety, PK, and Efficacy of the Myc Inhibitor OMO-103 Administered iv in Patients With PDAC (clinicaltrials.gov)
    P1, N=26, Active, not recruiting, Peptomyc S.L. | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2025 --> May 2026
    Enrollment closed • Trial primary completion date
    |
    gemcitabine • albumin-bound paclitaxel • OMO-103
    12ms
    OMO-103 for the Treatment of Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1, N=12, Not yet recruiting, OHSU Knight Cancer Institute
    New P1 trial
    |
    OMO-103
    over1year
    c-Myc-targeted therapy in breast cancer: A review of fundamentals and pharmacological Insights. (PubMed, Gene)
    Notably, the c-Myc inhibitor OMO-103 has shown promise in a Phase II clinical trial for advanced cancer patients. Further research is needed to develop new drugs targeting this gene, protein, or its pathways, and additional studies on cancer patients are encouraged.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • MYC (V-myc avian myelocytomatosis viral oncogene homolog)
    |
    EGFR positive
    |
    OMO-103
    over1year
    Osteomyc: A Phase 2 Pilot Study to Evaluate the Safety and the Anti-Tumour Activity of the Myc Inhibitor OMO-103 Administered Intravenously in Patients With Advanced High-Grade Osteosarcoma (clinicaltrials.gov)
    P2, N=10, Recruiting, Vall d'Hebron Institute of Oncology | Not yet recruiting --> Recruiting
    Enrollment open
    |
    OMO-103
    over1year
    OMO-103-02: Study to Evaluate the Safety, PK, and Efficacy of the Myc Inhibitor OMO-103 Administered Iv in Patients with PDAC (clinicaltrials.gov)
    P1, N=30, Recruiting, Peptomyc S.L. | Phase classification: P1b --> P1 | N=18 --> 30
    Phase classification • Enrollment change • Metastases
    |
    gemcitabine • albumin-bound paclitaxel • OMO-103
    over1year
    Osteomyc: A Phase 2 Pilot Study to Evaluate the Safety and the Anti-Tumour Activity of the Myc Inhibitor OMO-103 Administered Intravenously in Patients with Advanced High-Grade Osteosarcoma (clinicaltrials.gov)
    P2, N=10, Not yet recruiting, Vall d'Hebron Institute of Oncology
    New P2 trial • Metastases
    |
    OMO-103
    2years
    MYCure: Phase 1/2 Study to Evaluate Safety, PK and Efficacy of the MYC-Inhibitor OMO-103 in Solid Tumours (clinicaltrials.gov)
    P1/2, N=22, Terminated, Peptomyc S.L. | Active, not recruiting --> Terminated; Phase 1completed; sponsor decided to change strategy to a combination study
    Trial termination • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • RAS mutation
    |
    OMO-103
    3years
    Progress in the development of a clinically viable MYC inhibitor (EACR 2023)
    An Omomyc-based mini-protein therapeutic developed by Peptomyc S.L. – OMO-103 – has recently successfully completed a Phase 1 clinical study, demonstrating safety and clear signs of target engagement...ConclusionMYC inhibition is finally progressing through clinical trials and it is revealing new aspects of MYC biology, including in the context of immune modulation. The pleiotropic role of MYC in drug resistance and survival suggests that MYC inhibition could be useful to increase the efficacy of – and prevent resistance to – standard-of-care therapies.
    Clinical • PARP Biomarker
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    OMO-103
    almost4years
    MYCure: Phase 1/2 Study to Evaluate Safety, PK and Efficacy of the MYC-Inhibitor OMO-103 in Solid Tumours (clinicaltrials.gov)
    P1/2, N=22, Active, not recruiting, Peptomyc S.L. | Recruiting --> Active, not recruiting | N=74 --> 22
    Enrollment closed • Enrollment change • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • RAS mutation
    |
    OMO-103
    5years
    MYCure: Phase 1/2 Study to Evaluate Safety, PK and Efficacy of the MYC-Inhibitor OMO-103 in Solid Tumours (clinicaltrials.gov)
    P1/2, N=74, Recruiting, Peptomyc S.L. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation
    |
    OMO-103