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    DRUG CLASS:

    Natural cytotoxicity triggering receptor 1 agonist

    Related drugs:
    4ms
    A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies (clinicaltrials.gov)
    P1/2, N=7, Terminated, Sanofi | N=18 --> 7 | Active, not recruiting --> Terminated; Early discontinuation based on strategic sponsor decision not driven by any safety concerns
    Enrollment change • Trial termination
    |
    Venclexta (venetoclax) • azacitidine • IPH6101
    4ms
    A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies (clinicaltrials.gov)
    P1/2, N=18, Active, not recruiting, Sanofi | Trial completion date: Jun 2026 --> Aug 2025
    Trial completion date
    |
    Venclexta (venetoclax) • azacitidine • IPH6101
    5ms
    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=101, Terminated, Sanofi | N=169 --> 101 | Trial completion date: May 2029 --> May 2025 | Recruiting --> Terminated | Trial primary completion date: Nov 2028 --> May 2025; Early discontinuation based on strategic sponsor decision not driven by any safety concerns.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    IPH6101
    5ms
    A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies (clinicaltrials.gov)
    P1/2, N=18, Active, not recruiting, Sanofi | Recruiting --> Active, not recruiting | Trial completion date: Aug 2029 --> Jun 2026 | Trial primary completion date: Feb 2029 --> Oct 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Venclexta (venetoclax) • azacitidine • IPH6101
    11ms
    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 | Trial completion date: Oct 2030 --> May 2029 | Trial primary completion date: Dec 2025 --> Nov 2028
    Trial completion date • Trial primary completion date
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    IPH6101
    1year
    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 • IPH6101
    1year
    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)
    |
    IPH6101
    over1year
    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 • IPH6101
    over2years
    Derivation and Preclinical Characterization of CYT-303, a Novel NKp46-NK Cell Engager Targeting GPC3. (PubMed, Cells)
    In vivo, CYT-303 showed no toxicity or cytokine release in cynomolgus monkeys up to the highest dose (60 mg/kg), administered weekly by intravenous infusion for 28 days. These results demonstrate the potential of CYT-303 to be a safe and effective therapy against HCC.
    Preclinical • Journal
    |
    GPC3 (Glypican 3)
    |
    GPC3 expression
    |
    NY-303
    over2years
    CYT-303 FLEX-NKTM engager dose response efficacy mechanisms in HCC tumor model and safety in cynomolgus monkey toxicology studies support clinical evaluation in hepato-cellular carcinoma (AACR 2023)
    CYT-303 efficacious doses identified in the HCC model together with safety in cynomolgus monkeys and planned human pharmacokinetic modeling studies support clinical evaluation of CYT-303 in first in human HCC clinical trials.
    Preclinical
    |
    GPC3 (Glypican 3)
    |
    GPC3 expression
    |
    NY-303
    over2years
    Improved anti-tumor immune functions of iPSC-derived NK cells with TGFβR2 knock-out and/or IL-15 knock-in by TALEN® editing for use alone or in combination with GPC3 Flex-NKTM bispecific antibody (AACR 2023)
    This work demonstrates that KI of IL-15 and KO of TGFβR2 is a promising strategy for TALEN®-engineered iNK cell therapies to overcome the immunosuppressive TME and mount a potent and persistent anti-tumor immune response. The data also provide a solid foundation for combining these edited iNK cells with CYT-303 to address the immunosuppressive TME towards a cure for HCC.
    Combination therapy
    |
    GPC3 (Glypican 3) • TGFBR2 (Transforming Growth Factor Beta Receptor 2) • TGFB1 (Transforming Growth Factor Beta 1) • IL15 (Interleukin 15) • NKG2D (killer cell lectin like receptor K1)
    |
    GPC3 expression
    |
    NY-303