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    DRUG:

    HC-7366

    i
    Other names: HC-7366, HC-7366-K, HC 7366, HC7366, HC7366K, HC 7366 K
    Company:
    HiberCell
    Drug class:
    GCN2 activator
    Related drugs:
    6ms
    Phase I Study of HC-7366 With Azacitidine and Venetoclax for Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=18, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting | Initiation date: Aug 2024 --> May 2024
    Enrollment open • Trial initiation date
    |
    Venclexta (venetoclax) • azacitidine • HC-7366
    8ms
    Phase I Study of HC-7366 With Azacitidine and Venetoclax for Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, M.D. Anderson Cancer Center | N=58 --> 18
    Enrollment change
    |
    Venclexta (venetoclax) • azacitidine • HC-7366
    9ms
    A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma (clinicaltrials.gov)
    P1, N=80, Recruiting, HiberCell, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    VHL (von Hippel-Lindau tumor suppressor)
    |
    VHL mutation
    |
    Welireg (belzutifan) • HC-7366
    9ms
    A Study of HC-7366 to Establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) (clinicaltrials.gov)
    P1, N=35, Terminated, HiberCell, Inc. | N=70 --> 35 | Trial completion date: Oct 2024 --> Mar 2024 | Recruiting --> Terminated; sponsor decision
    Enrollment change • Trial completion date • Trial termination • Metastases
    |
    HC-7366
    9ms
    Phase I Study of HC-7366 With Azacitidine and Venetoclax for Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=58, Not yet recruiting, M.D. Anderson Cancer Center
    New P1 trial
    |
    Venclexta (venetoclax) • azacitidine • HC-7366
    10ms
    A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma (clinicaltrials.gov)
    P1, N=80, Not yet recruiting, HiberCell, Inc.
    New P1 trial
    |
    VHL (von Hippel-Lindau tumor suppressor)
    |
    VHL mutation
    |
    Welireg (belzutifan) • HC-7366
    1year
    Activation of GCN2 By HC-7366 Results in Significant Anti-Tumor Efficacy As Monotherapy and Overcomes Resistance Mechanisms When Combined with Venetoclax in AML (ASH 2023)
    Venetoclax (anti-BCL2) is approved for elderly patients with acute myeloid leukemia (AML) in combination with hypomethylating agents such as azacitidine or decitabine. Our in vitro and in vivo results demonstrate that HC-7366 is a potent GCN2 activator with strong antitumor activity in AML as a single agent and in combination with venetoclax. The potential of HC-7366 to counteract multiple known resistance mechanisms to venetoclax could provide a viable treatment option for patients with relapsed/refractory AML when used in combination with venetoclax.
    Clinical • IO biomarker
    |
    FLT3 (Fms-related tyrosine kinase 3) • S100A8 (S100 Calcium Binding Protein A8) • ATF4 (Activating Transcription Factor 4)
    |
    TP53 mutation • FLT3-ITD mutation • S100A8 expression
    |
    Venclexta (venetoclax) • azacitidine • decitabine • HC-7366
    over1year
    Activation of GCN2 by HC-7366 results in significant antitumor efficacy as monotherapy and in combination with multiple standard of care agents in various solid cancer models (AACR 2023)
    Furthermore, HC-7366 showed significant benefit in colorectal models when combined with DC101 (anti-VEGFR2 antibody), 5-fluorouracil (chemotherapy), alpelisib (PI3Kα inhibitor), or trametinib (MEK1/2 inhibitor). ATF4 and JUN transcriptional activity was enhanced with HC-7366 treatment consistent with activation of ISR. Collectively, our in vitro and in vivo results demonstrate that HC-7366 is a potent GCN2 activator with strong antitumor activity across multiple solid tumor models as a monotherapy or in combination with standard of care agents.
    Clinical • Preclinical • Combination therapy
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • HIF1A (Hypoxia inducible factor 1, alpha subunit) • ATF4 (Activating Transcription Factor 4) • E2F1 (E2F transcription factor 1)
    |
    Mekinist (trametinib) • 5-fluorouracil • Piqray (alpelisib) • DC101 • HC-7366