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DRUG:

SAR443579

i
Other names: SAR443579, IPH6101, IPH61, SAR’579
Company:
Innate, Sanofi
Drug class:
NK cell stimulant, CD123 inhibitor, CD16 agonist, Natural cytotoxicity triggering receptor 1 agonist
Related drugs:
2ms
Enrollment change • Trial completion date
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IL3RA (Interleukin 3 Receptor Subunit Alpha)
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SAR443579
4ms
New P1/2 trial
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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
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CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
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CD123 positive • IL3RA positive
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Venclexta (venetoclax) • 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
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IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
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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
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CD123 (Interleukin 3 Receptor Subunit Alpha) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
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CD123 positive
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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
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CD123 (Interleukin 3 Receptor Subunit Alpha) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
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CD123 positive
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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
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CD123 (Interleukin 3 Receptor Subunit Alpha) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
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CD123 positive
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hydroxyurea • SAR443579