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    DRUG:

    SGR-2921

    i
    Other names: SGR-2921, SDGR1, SDGR 1, SGR2921, SDGR-1, SGR 2921
    Company:
    Schrodinger
    Drug class:
    CDC7 kinase inhibitor
    Related drugs:
    12ms
    SGR-2921-101: Study of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov)
    P1, N=50, Recruiting, Schrödinger, Inc.
    Trial completion date • Trial primary completion date
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    SGR-2921
    1year
    Sgr-2921, a Potent CDC7 Inhibitor, Demonstrates Significant Anti-Leukemic Responses in Patient-Derived AML Models Representing Difficult-to-Treat Disease (ASH 2023)
    Our data show remarkable dose-dependent in vivo activity of SGR-2921 in AML PDX models, including in those representing difficult-to-treat disease. Direct inhibition of CDC7 by SGR-2921 in AML blasts was demonstrated by a dose-dependent reduction of phosphorylated MCM2. Together, these data demonstrate that SGR-2921-mediated CDC7 inhibition is an attractive novel treatment opportunity in AML, with potential utility in patients with high risk mutations and relapsed and refractory AML.
    Clinical • BRCA Biomarker
    |
    TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • CDC7 (Cell Division Cycle 7) • MCM2 (Minichromosome maintenance complex component 2)
    |
    TP53 mutation
    |
    SGR-2921
    1year
    A First-in-Human, Phase 1, Dose Escalation Study of Sgr-2921 As Monotherapy in Subjects with Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome (ASH 2023)
    The study primary objectives are to evaluate the safety and tolerability of SGR-2921 as monotherapy and identify RP2D including MTD. Secondary objectives include evaluating the pharmacokinetics (PK) of SGR-2921 and investigating preliminary antitumor activity (composite complete remission rate, objective response rate, duration of response, etc.).
    Clinical • P1 data
    |
    TP53 (Tumor protein P53) • FLT3 (Fms-related tyrosine kinase 3) • CDC7 (Cell Division Cycle 7)
    |
    TP53 mutation • FLT3 mutation
    |
    SGR-2921
    1year
    SGR-2921-101: Study of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov)
    P1, N=50, Recruiting, Schrödinger, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    SGR-2921
    over1year
    Study of SGR-2921 in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov)
    P1, N=50, Not yet recruiting, Schrödinger, Inc.
    New P1 trial
    |
    BCL2 (B-cell CLL/lymphoma 2)
    |
    SGR-2921
    2years
    Inhibition of CDC7 with Sgr-2921 in AML Models Results in Enhanced DNA Damage and Anti-Leukemic Activity As Monotherapy and in Combination with Standard of Care Agents (ASH 2022)
    Combination of SGR-2921 with venetoclax (BCL2 inhibitor) showed synergy on anti-tumor activity both in vitro and in vivo. SGR-2921, a novel, potent CDC7 small molecule inhibitor, demonstrates strong anti-proliferative activity both in vitro in AML cell models and in vivo in AML xenograft models. SGR-2921 showed synergistic inhibitory effects on cell-proliferation and tumor growth in combination with standard of care agents, and was anti-proliferative in AML cell lines and patient samples resistant to standard of care agents. Together, these data show that SGR-2921-mediated CDC7 inhibition is an attractive novel treatment opportunity in AML, with a potential utility in patients with relapsed and refractory AML.
    Combination therapy • BRCA Biomarker • IO biomarker
    |
    FLT3 (Fms-related tyrosine kinase 3) • BRCA1 (Breast cancer 1, early onset) • CDC7 (Cell Division Cycle 7)
    |
    Venclexta (venetoclax) • SGR-2921