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    DRUG:

    imvotamab (IGM-2323)

    i
    Other names: IGM-2323, IGM2323, IGM 2323
    Company:
    IGM Biosciences
    Drug class:
    CD20 inhibitor, CD3 agonist
    Related drugs:
    16d
    IGM-2323-102: A Phase 1b Study of Imvotamab in Moderate to Severe Rheumatoid Arthritis (clinicaltrials.gov)
    P1, N=40, Recruiting, IGM Biosciences, Inc. | N=24 --> 40 | Trial completion date: Jul 2025 --> May 2026 | Trial primary completion date: Feb 2025 --> May 2025
    Enrollment change • Trial completion date • Trial primary completion date
    |
    CRP (C-reactive protein)
    |
    imvotamab (IGM-2323)
    4ms
    A Study of Imvotamab in Active, Refractory Idiopathic Inflammatory Myopathies (clinicaltrials.gov)
    P1, N=10, Recruiting, IGM Biosciences, Inc.
    New P1 trial
    |
    imvotamab (IGM-2323)
    4ms
    IGM-2323-001: A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=97, Terminated, IGM Biosciences, Inc. | Trial completion date: Oct 2024 --> Feb 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Oct 2024 --> Feb 2024; Strategic Pipeline Prioritization: Clinical development of imvotamab in autoimmune diseases prioritized.
    Trial completion date • Trial termination • Trial primary completion date
    |
    Zynlonta (loncastuximab tesirine-lpyl) • imvotamab (IGM-2323)
    8ms
    Expanded Access of Imvotamab (IGM-2323) in Patients With R/R NHL (clinicaltrials.gov)
    P=N/A, N=0, No Longer Available, IGM Biosciences, Inc.
    New trial
    |
    imvotamab (IGM-2323)
    10ms
    A Study of Imvotamab in Severe Systemic Lupus Erythematosus (clinicaltrials.gov)
    P1, N=18, Recruiting, IGM Biosciences, Inc. | Phase classification: P1b --> P1
    Phase classification
    |
    imvotamab (IGM-2323)
    10ms
    A Phase 1b Study of Imvotamab in Moderate to Severe Rheumatoid Arthritis (clinicaltrials.gov)
    P1, N=24, Recruiting, IGM Biosciences, Inc. | Phase classification: P1b --> P1
    Phase classification
    |
    CRP (C-reactive protein)
    |
    imvotamab (IGM-2323)
    11ms
    A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=97, Active, not recruiting, IGM Biosciences, Inc.
    Trial completion date • Trial primary completion date
    |
    imvotamab (IGM-2323)
    1year
    A Phase 1b Study of Imvotamab in Moderate to Severe Rheumatoid Arthritis (clinicaltrials.gov)
    P1b, N=24, Recruiting, IGM Biosciences, Inc.
    New P1 trial
    |
    CRP (C-reactive protein)
    |
    imvotamab (IGM-2323)
    1year
    A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=97, Active, not recruiting, IGM Biosciences, Inc. | Recruiting --> Active, not recruiting | N=260 --> 97 | Trial primary completion date: Sep 2024 --> Oct 2023
    Enrollment closed • Enrollment change • Trial primary completion date
    |
    imvotamab (IGM-2323)
    over1year
    SAFETY AND EFFICACY OF ANTICD20-CD3 BISPECIFIC T-CELL ENGAGING ANTIBODIES IN THE MANAGEMENT OF RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA: A SYSTEMATIC REVIEW OF CLINICAL TRIALS (EHA 2023)
    In the trials, mosunetuzumab, glofitamab, epcoritamab, odronextamab, IGM-2323, and plamotamab were identified as antiCD20-CD3 bsAbs, which are evaluated against RRDLBCL as monotherapy and in combination regimens (Table). Based on our analysis , antiCD20-CD3 bsAbs are safe and efficacious. Among these drugs, glofitamab, epcoritamab and odronextamab as monotherapy and/or in combination regimens are the most effective therapies against RRDLBCL. Drug (s) **Author Efficac y ORR, CR per Lugano/RR C for ML criteria **CRS Overall/G 3 per ASTCT/ Lee et al criteria Overall Toxicity G≥3 per CTCAE CNS Toxicity G≥3 Per CTCAE aNHL 35%Mosun IV Budde et al.
    Clinical • Review
    |
    Epkinly (epcoritamab-bysp) • Lunsumio (mosunetuzumab-axgb) • imvotamab (IGM-2323) • Columvi (glofitamab-gxbm) • Ordspono (odronextamab) • plamotamab (XmAb13676)
    over2years
    DOSE RESPONSE PROFILE OF IGM-2323, A CD20XCD3 IGM BISPECIFIC T CELL ENGAGER, IN TRANSLATIONAL MODELS SUPPORTS PHASE 2 DOSE SELECTION IN NON-HODGKIN'S LYMPHOMA (EHA 2022)
    Conclusion IGM-2323 shows a bell-shaped dose versus response relationship preclinically, with high concentrations associated with reduced T cell activity. The in vitro data support the decision to move forward with our randomized Phase 2 design testing 100 mg and 300 mg dose levels in NHL patients.
    P2 data
    |
    IFNG (Interferon, gamma) • CD69 (CD69 Molecule)
    |
    CD20 expression
    |
    imvotamab (IGM-2323)
    3years
    A Phase 1 Dose Escalation Study of Igm-2323, a Novel Anti-CD20 x Anti-CD3 IgM T Cell Engager (TCE) in Patients with Advanced B-Cell Malignancies (ASH 2021)
    Updated safety, PK, biomarker, and efficacy data, including complete dose escalation data, will be presented at the meeting. * starting and plateau dose referenced
    Clinical • P1 data • IO biomarker
    |
    CD20 (Membrane Spanning 4-Domains A1) • IFNG (Interferon, gamma)
    |
    imvotamab (IGM-2323)
    4years
    [VIRTUAL] Preliminary Results of a Phase 1 Dose Escalation Study of the First-in-Class IgM Based Bispecific Antibody Igm-2323 (anti-CD20 x anti-CD3) in Patients with Advanced B-Cell Malignancies (ASH 2020)
    Updated safety, pharmacokinetic, biomarker, and efficacy data will be presented at the meeting. This study is registered with clinicaltrials.gov identifier NCT04082936.
    Clinical • P1 data
    |
    CD20 (Membrane Spanning 4-Domains A1) • IFNG (Interferon, gamma) • IL6 (Interleukin 6)
    |
    CD20 positive
    |
    imvotamab (IGM-2323)