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    DRUG:

    lemzoparlimab (ABBV-IMAB-TJC4)

    i
    Other names: ABBV-IMAB-TJC4, TJ011133, TJ-011133, TJC-4, TJC4, TJ1133
    Company:
    I-Mab
    Drug class:
    CD47 inhibitor
    Related drugs:
    10ms
    A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov)
    P1/2, N=105, Completed, I-Mab Biopharma Co. Ltd. | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Dec 2023 | Trial primary completion date: Dec 2024 --> Dec 2023
    Trial completion • Trial completion date • Trial primary completion date • Combination therapy
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    azacitidine • lemzoparlimab (ABBV-IMAB-TJC4)
    10ms
    Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome (clinicaltrials.gov)
    P1, N=40, Terminated, AbbVie | Phase classification: P1b --> P1 | Completed --> Terminated; Strategic considerations
    Phase classification • Trial termination • Adverse events • Combination therapy
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    Venclexta (venetoclax) • azacitidine • lemzoparlimab (ABBV-IMAB-TJC4)
    10ms
    A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov)
    P1/2, N=105, Active, not recruiting, I-Mab Biopharma Co. Ltd. | Trial completion date: Feb 2024 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    azacitidine • lemzoparlimab (ABBV-IMAB-TJC4)
    over1year
    Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome (clinicaltrials.gov)
    P1b, N=40, Completed, AbbVie | Active, not recruiting --> Completed | N=80 --> 40
    Trial completion • Enrollment change • Adverse events • Combination therapy
    |
    Venclexta (venetoclax) • azacitidine • lemzoparlimab (ABBV-IMAB-TJC4)
    2years
    Exploration of the Therapeutic Effects of CD47 and CD38 Antibody Combination in Relapsed or Refractory Multiple Myeloma (rrMM) and the Correlation with CD47 and CD38 Expression (ASH 2022)
    Combination of lemzoparlimab and felzartamab showed enhanced in vitro ADCP and in vivo anti-tumor efficacy in these CD47 high and CD38 low high-risk MM cells which were resistant to felzartamab or daratumumab mono-treatment. Our study provides preclinical evidence to explore the combination of lemzoparlimab and felzartamab in the treatment of high-risk MM patients.
    IO biomarker
    |
    CD47 (CD47 Molecule) • TGFB1 (Transforming Growth Factor Beta 1) • SIRPA (Signal Regulatory Protein Alpha)
    |
    CD38 expression • CD47 overexpression • CD47 expression • CD38 overexpression
    |
    Darzalex (daratumumab) • lemzoparlimab (ABBV-IMAB-TJC4) • felzartamab (MOR202)
    2years
    Molecular Biomarker Analyses for Exploring the Therapeutic Mechanism of Lemzoparlimab and Azacitidine (AZA) in Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (ASH 2022)
    Here we show that an increased CALR expression in CD33+ blasts after lemzoparlimab and AZA combination treatment and higher immune infiltrates including total, CD91+ macrophages and CD8/Treg ratio in bone marrow at baseline is associated with better clinical response, suggesting the important role of activation of tumor derived pro-phagocytic signal and effector immune cells in the anti-tumor activity mediated by combination treatment. In addition, TP53 mutant patients with a higher increase in CALR expression and immune infiltrates in bone marrow showed a better clinical response than those with WT TP53. Our results pinpoint the potential mechanism of clinical benefits observed with lemzoparlimab and AZA treatment in HR-MDS and provide insight into future combination strategies.
    CD8 (cluster of differentiation 8) • CD47 (CD47 Molecule) • CD33 (CD33 Molecule) • CD68 (CD68 Molecule) • CALR (Calreticulin)
    |
    TP53 mutation • TP53 wild-type • CD47 expression
    |
    azacitidine • lemzoparlimab (ABBV-IMAB-TJC4)
    2years
    Combination of HER2 ADC and lemzoparlimab elicits enhanced efficacy in both HER2 high-and low-expressing breast and gastric cancers (SITC 2022)
    In vitro cytotoxicity of RC48 (Disitamab Vedotin), alone or in combination with lemzoparlimab was evaluated in co-culture of human PBMC with tumor cell lines. In vivo activity of RC48 or in-house produced DS8201 analogue in combination with lemzoparlimab were investigated in CDX (HER2 0/1+/3+ by IHC) and PDX (HER2 2+ by IHC) models...Lemzoparlimab potentiated HER2 ADC mediated tumor killing by modulating NK cells and macrophage activity to increase cytotoxicity and phagocytosis. These data support future clinical investigation of lemzoparlimab and HER2 ADC combination in HER2 positive patients, especially those with HER2-low expressing tumors.
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • CD47 (CD47 Molecule) • CD68 (CD68 Molecule)
    |
    HER-2 positive • HER-2 overexpression • HER-2 expression • HER-2 underexpression • HER-2-H
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Aidixi (disitamab vedotin) • lemzoparlimab (ABBV-IMAB-TJC4)
    over2years
    LEMZOPARLIMAB (LEMZO) WITH VENETOCLAX (VEN) AND/OR AZACITIDINE (AZA) IN PATIENTS (PTS) WITH ACUTE MYELOID LEUKEMIA (AML) OR MYELODYSPLASTIC SYNDROMES (MDS): A PHASE 1B DOSE ESCALATION STUDY (EHA 2022)
    Time-to-event endpoints will be analyzed using Kaplan–Meier methodology. Results N/A Conclusion N/A
    Clinical • P1 data
    |
    CD47 (CD47 Molecule)
    |
    CD47 overexpression
    |
    Venclexta (venetoclax) • azacitidine • lemzoparlimab (ABBV-IMAB-TJC4)
    over2years
    Anti-CD47 immunotherapy in combination with BCL-2 inhibitor to enhance anti-tumor activity in B-cell lymphoma. (PubMed, Hematol Oncol)
    The present study aimed to explore whether TJC4-Venetoclax combined therapy exerts synergistic anti-cancer properties in B-cell lymphoma. In vitro and in vivo, the TJC4-Venetoclax combination increased phagocytosis significantly compared with either agent alone, showing synergistic phagocytosis, and displayed synergistic anti-cancer properties in B-cell lymphoma. Our results support the TJC4-Venetoclax combination as a promising therapy, and suppressing BCL-2 and CD47 simultaneously could represent a novel therapeutic paradigm for B-cell lymphoma.
    Journal • Combination therapy
    |
    CD47 (CD47 Molecule)
    |
    Venclexta (venetoclax) • lemzoparlimab (ABBV-IMAB-TJC4)
    almost3years
    A Study of Single Drug TJ011133 and Toripalimab Combine Treatment for Advanced Solid Tumor (clinicaltrials.gov)
    P1/2, N=96, Recruiting, I-Mab Biopharma Co. Ltd. | Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2021 --> Dec 2023
    Clinical • Enrollment open • Trial primary completion date • Combination therapy
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    SIRPA (Signal Regulatory Protein Alpha)
    |
    Loqtorzi (toripalimab-tpzi) • lemzoparlimab (ABBV-IMAB-TJC4)
    3years
    A Study of Single Drug TJ011133 and Toripalimab Combine Treatment for Advanced Solid Tumor (clinicaltrials.gov)
    P1/2, N=96, Not yet recruiting, I-Mab Biopharma Co. Ltd.
    Clinical • New P1/2 trial • Combination therapy
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    Loqtorzi (toripalimab-tpzi) • lemzoparlimab (ABBV-IMAB-TJC4)