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

    SIRPA inhibitor

    Related drugs:
    23d
    BYON4228.001: First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228 (clinicaltrials.gov)
    P1, N=17, Active, not recruiting, Byondis B.V. | Recruiting --> Active, not recruiting | N=100 --> 17 | Trial completion date: Dec 2025 --> May 2026 | Trial primary completion date: Oct 2025 --> Feb 2026
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • First-in-human
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    Rituxan (rituximab) • Truxima (rituximab-abbs) • BYON4228
    24d
    A Dose Escalation and Expansion Trial With BYON4228 Alone and in Combination in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=7, Active, not recruiting, Byondis B.V. | Recruiting --> Active, not recruiting | N=85 --> 7 | Trial completion date: Sep 2027 --> Dec 2026 | Trial primary completion date: May 2027 --> Apr 2026
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • BYON4228
    2ms
    Signal regulating proteins (SIRPs) participate in sarcoidosis granuloma formation by promoting immune cell aggregation. (PubMed, Respir Res)
    SIRPα is robustly expressed in monocyte/macrophage lineages within human sarcoidosis tissues, and inhibition of SIRPs (ELA026) suppresses sarcoidosis granuloma formation by preventing macrophage adhesion/aggregation.
    Journal
    |
    TNFA (Tumor Necrosis Factor-Alpha) • IL1B (Interleukin 1, beta) • SIRPA (Signal Regulatory Protein Alpha)
    |
    prednisone
    6ms
    A Dose Escalation and Expansion Trial With BYON4228 Alone and in Combination in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=85, Recruiting, Byondis B.V. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • BYON4228
    8ms
    ELA026 CP002: Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH) (clinicaltrials.gov)
    P2/3, N=156, Recruiting, Electra Therapeutics Inc. | Active, not recruiting --> Recruiting
    Enrollment open
    10ms
    A Dose Escalation and Expansion Trial With BYON4228 Alone and in Combination in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=85, Not yet recruiting, Byondis B.V.
    New P1 trial
    |
    Keytruda (pembrolizumab) • BYON4228
    11ms
    ELA026 CP002: Open-label Study of ELA026 in Participants with Secondary Hemophagocytic Lymphohistiocytosis (sHLH) (clinicaltrials.gov)
    P2/3, N=156, Active, not recruiting, Electra Therapeutics Inc. | Recruiting --> Active, not recruiting | Phase classification: P1 --> P2/3 | N=24 --> 156 | Trial completion date: Mar 2025 --> Jun 2029 | Trial primary completion date: Dec 2024 --> Jun 2027
    Enrollment closed • Phase classification • Enrollment change • Trial completion date • Trial primary completion date
    1year
    BYON4228.001: First-in-human Dose Escalation and Expansion Study With the SIRPα-directed Monoclonal Antibody BYON4228 (clinicaltrials.gov)
    P1, N=100, Recruiting, Byondis B.V. | Trial primary completion date: Oct 2024 --> Oct 2025
    Trial primary completion date • Combination therapy
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 expression
    |
    Rituxan (rituximab) • Truxima (rituximab-abbs) • BYON4228
    over1year
    A pan-allelic human SIRPα-blocking antibody, ES004-B5, promotes tumor killing by enhancing macrophage phagocytosis and subsequently inducing an effective T-cell response. (PubMed, Antib Ther)
    Unlike CD47-targeted agents, ES004-B5 exhibits an excellent safety profile in nonhuman primates. ES004-B5 has potential to be an important backbone for SIRPα-based combination therapy and/or bispecific antibodies, which will likely overcome the limitations of CD47-targeted agents encountered in clinical settings.
    Journal • IO biomarker
    |
    CD47 (CD47 Molecule) • SIRPA (Signal Regulatory Protein Alpha)
    |
    CD47 expression
    over1year
    ELA026 CP002: Evaluation of the Safety and Efficacy of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (clinicaltrials.gov)
    P1, N=24, Recruiting, Electra Therapeutics Inc. | Phase classification: P1b --> P1 | Trial completion date: Jun 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Dec 2024
    Phase classification • Trial completion date • Trial primary completion date
    over1year
    Blockade of SIRPα-CD47 axis by anti-SIRPα antibody enhances anti-tumor activity of DXd antibody-drug conjugates. (PubMed, PLoS One)
    To this end, DS-1103a, a newly developed anti-human SIRPα antibody (Ab), was assessed for the potential combination benefit with datopotamab deruxtecan (Dato-DXd) and trastuzumab deruxtecan (T-DXd), DXd-ADCs targeting human trophoblast cell-surface antigen 2 and human epidermal growth factor receptor 2, respectively. Furthermore, in syngeneic mouse models, both Dato-DXd and T-DXd combination with anti-mSIRPα Ab showed stronger anti-tumor activity over the monotherapies. Taken together, this study provides a preclinical rationale of novel therapies for solid tumors combining SIRPα-CD47 blockers with DXd-ADCs.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • SIRPA (Signal Regulatory Protein Alpha)
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Datroway (datopotamab deruxtecan-dlnk) • DS-1103
    almost2years
    Evaluation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ELA026 in Single and Multiple Doses in Healthy Volunteers (clinicaltrials.gov)
    P1, N=91, Completed, Electra Therapeutics Inc. | Recruiting --> Completed | Trial completion date: Apr 2024 --> Nov 2023 | Trial primary completion date: Apr 2024 --> Nov 2023
    Trial completion • Trial completion date • Trial primary completion date