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    DRUG:

    timdarpacept (IMM01)

    i
    Other names: IMM01, IMM-01, IMM 01, IMC-001
    Associations

    News

    Trials
    Company:
    ImmuneOnco Biopharma
    Drug class:
    CD47 inhibitor
    Related drugs:
    Associations

    News

    Trials
    16h
    DISTINKT: A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type (clinicaltrials.gov)
    P2, N=23, Active, not recruiting, ImmuneOncia Therapeutics Inc. | Trial completion date: Feb 2026 --> Feb 2027
    Trial completion date
    |
    danburstotug (IMC-001) • timdarpacept (IMM01)
    5d
    A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor (clinicaltrials.gov)
    P2, N=30, Recruiting, ImmuneOncia Therapeutics Inc. | Trial primary completion date: Dec 2026 --> Jun 2027
    Trial primary completion date
    |
    TMB (Tumor Mutational Burden)
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    TMB-H
    |
    TruSight Oncology 500 Assay
    |
    danburstotug (IMC-001) • timdarpacept (IMM01)
    7d
    A Clinical Study of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary Syndrome. (clinicaltrials.gov)
    P1, N=18, Recruiting, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Phase classification: P2 --> P1
    Phase classification
    |
    CRP (C-reactive protein)
    |
    danburstotug (IMC-001) • timdarpacept (IMM01)
    8d
    A Clinical Study of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary Syndrome. (clinicaltrials.gov)
    P2, N=18, Recruiting, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | N=30 --> 18 | Trial completion date: Jun 2026 --> Oct 2026 | Trial primary completion date: Jun 2026 --> Oct 2026
    Enrollment change • Trial completion date • Trial primary completion date
    |
    CRP (C-reactive protein)
    |
    danburstotug (IMC-001) • timdarpacept (IMM01)
    7ms
    A Study of IMM2510 + IMM01 Combination Therapy in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=104, Not yet recruiting, ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
    New P1/2 trial
    |
    timdarpacept (IMM01)
    8ms
    A Study Evaluating the Stability and Efficacy of IMC-001 for Injection on Atherosclerotic Plaques in Patients With ACS. (clinicaltrials.gov)
    P2, N=30, Recruiting, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | N=14 --> 30 | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Nov 2025 --> Jun 2026
    Enrollment change • Trial completion date • Trial primary completion date
    |
    danburstotug (IMC-001) • timdarpacept (IMM01)
    10ms
    A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor (clinicaltrials.gov)
    P2, N=30, Recruiting, ImmuneOncia Therapeutics Inc. | Not yet recruiting --> Recruiting | Trial completion date: Dec 2027 --> Aug 2029 | Trial primary completion date: Dec 2025 --> Dec 2026
    Enrollment open • Trial completion date • Trial primary completion date
    |
    danburstotug (IMC-001) • timdarpacept (IMM01)
    10ms
    A Study of IMC-001 on Improved Atherosclerotic Plaque Stability in Patients of ACS (clinicaltrials.gov)
    P2, N=14, Recruiting, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    danburstotug (IMC-001) • timdarpacept (IMM01)
    1year
    IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2) (clinicaltrials.gov)
    P3, N=170, Recruiting, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Trial primary completion date: Oct 2026 --> Apr 2026
    Trial primary completion date
    |
    azacitidine • timdarpacept (IMM01)
    1year
    A Study of IMC-001 on Improved Atherosclerotic Plaque Stability in Patients of ACS (clinicaltrials.gov)
    P2, N=14, Not yet recruiting, ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
    New P2 trial
    |
    danburstotug (IMC-001) • timdarpacept (IMM01)
    over1year
    IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2) (clinicaltrials.gov)
    P3, N=170, Recruiting, ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
    New P3 trial • Combination therapy
    |
    azacitidine • timdarpacept (IMM01)
    over1year
    DNp73 enhances tumor progression and immune evasion in multiple myeloma by targeting the MYC and MYCN pathways. (PubMed, Front Immunol)
    Blockade of the CD47/SIRPα and PD-1/PD-L1 signaling pathways by the SIRPα-Fc fusion protein IMM01 and monoclonal antibody atezolizumab significantly restored the anti-MM activity of macrophages and T cells in the microenvironment, respectively. Moreover, our study clarified that DNp73 overexpression not only promotes aggressive growth of tumor cells but, more importantly, promotes immune escape of MM cells through upregulation of immune checkpoints. DNp73 could serve as a biomarker for immunotherapy targeting PD-L1 and CD47 blockade in MM patients.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • CD47 (CD47 Molecule) • CDK7 (Cyclin Dependent Kinase 7) • SIRPA (Signal Regulatory Protein Alpha)
    |
    TP53 mutation • MYCN expression
    |
    Tecentriq (atezolizumab) • timdarpacept (IMM01)