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    DRUG:

    SAR443579

    i
    Other names: SAR443579, IPH6101, IPH61, SAR’579, IPH 61, IPH-61, IPH 6101, IPH-6101, SAR-443579, SAR 443579
    Company:
    Innate, Sanofi
    Drug class:
    NK cell stimulant, CD123 inhibitor, CD16 agonist, Natural cytotoxicity triggering receptor 1 agonist
    Related drugs:
    23d
    A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies (clinicaltrials.gov)
    P1/2, N=18, Recruiting, Sanofi | Trial completion date: Feb 2029 --> Aug 2029
    Trial completion date
    |
    Venclexta (venetoclax) • azacitidine • SAR443579
    3ms
    TCD17197: First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (clinicaltrials.gov)
    P1/2, N=169, Recruiting, Sanofi | N=126 --> 169 | Trial completion date: Nov 2026 --> Oct 2030
    Enrollment change • Trial completion date
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    SAR443579
    5ms
    A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies (clinicaltrials.gov)
    P1/2, N=18, Recruiting, Sanofi
    New P1/2 trial
    |
    Venclexta (venetoclax) • azacitidine • SAR443579
    1year
    First-in-Human Study of the CD123 NK Cell Engager SAR443579 in Relapsed or Refractory Acute Myeloid Leukemia, B-Cell Acute Lymphoblastic Leukemia or High Risk-Myelodysplasia: Updated Safety, Efficacy, Pharmacokinetics and Pharmacodynamics (ASH 2023)
    Pts had received a median of 2.0 (1.0 –10.0) prior lines of treatment with 13 pts (30.2%) reporting prior hematopoietic stem cell transplantation and 36 pts (83.7%) with prior exposure to venetoclax. SAR'579 was well tolerated up to doses of 6000 µg/kg QW with observed clinical benefit in pts with R/R AML. The results are consistent with the predicted favorable safety profile.
    Clinical • P1 data • PK/PD data
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    CD123 positive • IL3RA positive
    |
    Venclexta (venetoclax) • SAR443579
    1year
    First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (clinicaltrials.gov)
    P1/2, N=126, Recruiting, Sanofi | N=82 --> 126
    Enrollment change
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    SAR443579
    over1year
    Preliminary pharmacokinetics (PK) and pharmacodynamic (PD) analysis of the CD123 NK cell engager (NKCE) SAR443579 in patients (pts) with relapsed or refractory acute myeloid leukemia (R/R AML), B cell acute lymphoblastic leukemia (B-ALL) or high risk-myelodysplasia (HR-MDS) (ESMO 2023)
    Observed peak cytokine levels did not show significant dose-related increase and no association between elevated peak cytokine levels and clinical responses. The results are consistent with the improved safety profile compared to CD123-targeted T-cell engagers.
    Clinical • PK/PD data
    |
    IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    SAR443579
    over1year
    A FIRST-IN-HUMAN STUDY OF CD123 NK CELL ENGAGER SAR443579 IN RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA, B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA OR HIGH RISK-MYELODYSPLASIA (EHA 2023)
    The median age was 70 years (range: 21 - 80) with 9 patients (39.1%) reporting prior hematopoietic stem cell transplantation (HSCT) and 16 (69.6%) had prior exposure to venetoclax. SAR’579 was well tolerated up to doses of 3000 µg/kg QW with observed clinical benefit in patients with R/R AML. The trial continues to accrue patients.
    P1 data
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
    |
    CD123 positive
    |
    Venclexta (venetoclax) • SAR443579
    over1year
    A first-in-human study of CD123 NK cell engager SAR443579 in relapsed or refractory acute myeloid leukemia, B-cell acute lymphoblastic leukemia, or high-risk myelodysplasia. (ASCO 2023)
    The median age was 70 years (range: 21 - 80) with 9 patients (39.1%) reporting prior hematopoietic stem cell transplantation (HSCT) and 16 (69.6%) had prior exposure to venetoclax. SAR’579 was well tolerated up to doses of 3000 µg/kg QW with observed clinical benefit in patients with R/R AML. The trial continues to accrue patients. Clinical trial information: NCT05086315.
    P1 data
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
    |
    CD123 positive
    |
    Venclexta (venetoclax) • SAR443579
    2years
    An Open-Label, First-in-Human, Dose-Escalation Study of SAR443579 Administered As Single Agent By Intravenous Infusion in Patients with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-Cell Acute Lymphoblastic Leukemia (B-ALL) or High-Risk Myelodysplasia (HR-MDS) (ASH 2022)
    Patients with white blood cell count ≥15000/mm3 are excluded and use of hydroxyurea should be discontinued at least 1 day before first planned IMP administration. This study will be conducted in Australia, France, the Netherlands, and the United States. Recruitment is ongoing and this trial is registered on clinicaltrials.gov: NCT05086315
    Clinical • P1 data
    |
    CD123 (Interleukin 3 Receptor Subunit Alpha) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
    |
    CD123 positive
    |
    hydroxyurea • SAR443579