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    DRUG:

    amezalpat (TPST-1120)

    i
    Other names: TPST-1120, TPST 1120, TPST1120
    Company:
    Tempest Therap
    Drug class:
    PPAR α antagonist
    6d
    A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (clinicaltrials.gov)
    P1/2, N=518, Recruiting, Hoffmann-La Roche | Trial completion date: Aug 2026 --> Dec 2026 | Trial primary completion date: Aug 2026 --> Dec 2026
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • amezalpat (TPST-1120) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • IO-108 • NKT2152 • muzastotug (ADG126) • tobemstomig (RG6139)
    1m
    A Study of TPST-1120 With Atezolizumab Plus Bevacizumab in Patients With Unresectable or Metastatic HCC Not Previously Treated With Systemic Therapy (clinicaltrials.gov)
    P3, N=740, Not yet recruiting, Tempest Therapeutics
    New P3 trial • Combination therapy • Metastases
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • amezalpat (TPST-1120)
    7ms
    A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (clinicaltrials.gov)
    P1/2, N=506, Recruiting, Hoffmann-La Roche | Trial completion date: Dec 2025 --> Aug 2026 | Trial primary completion date: Dec 2025 --> Aug 2026
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • amezalpat (TPST-1120) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • NKT2152 • muzastotug (ADG126) • tobemstomig (RG6139)
    9ms
    First-in-Human Phase I Trial of TPST-1120, an inhibitor of PPARα, as Monotherapy or in Combination with Nivolumab, in Patients with Advanced Solid Tumors. (PubMed, Cancer Res Commun)
    TPST-1120 was well tolerated as monotherapy and in combination with nivolumab and the combination showed preliminary evidence of clinical activity in PD-1 inhibitor refractory and immune compromised cancers.
    Journal • Combination therapy • Metastases
    |
    PPARA (Peroxisome Proliferator Activated Receptor Alpha)
    |
    Opdivo (nivolumab) • amezalpat (TPST-1120)
    1year
    Pharmacodynamics and gene expression analysis of patients with renal cell carcinoma treated with combination nivolumab and TPST-1120 in a phase I clinical trial (NCT03829436). (ASCO-GU 2024)
    There is a paucity of treatment options for patients with stage IV RCC post anti-PD1 and anti-VEGF therapies. Novel therapies on this clinical scenario are needed. On this abstract we showed radiographic and pharmacodynamic data on patients with RCC who achieved a clinical partial response by RECIST on the phase I clinical trial TPST1120-001.
    PK/PD data • Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    ACSL3 (Acyl-CoA Synthetase Long Chain Family Member 3) • FABP1 (Fatty Acid Binding Protein 1)
    |
    PredicineCARE™
    |
    Opdivo (nivolumab) • amezalpat (TPST-1120)
    over1year
    TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers (clinicaltrials.gov)
    P1, N=38, Completed, Tempest Therapeutics | Active, not recruiting --> Completed | N=138 --> 38 | Trial completion date: Jun 2024 --> Sep 2022
    Trial completion • Enrollment change • Trial completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • amezalpat (TPST-1120)
    almost2years
    Lipid and immune-based biomarkers associated with clinical response to TPST-1120: A small molecule antagonist of peroxisome-proliferator activated receptor-alpha (AACR 2023)
    TPST-1120 was well tolerated and showed signs of activity in a phase I trial as monotherapy and in combination with nivolumab (NCT03829436). TPST-1120 treated patients with PR demonstrated fatty acid oxidation perturbations and immune gene expression changes as potential biomarkers of clinical benefit. Increased frequencies of responding patients bearing PI3K pathway or IDH mutations may reveal populations likely to benefit from treatment with TPST-1120. 1.
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    PTEN (Phosphatase and tensin homolog) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • PVR (PVR Cell Adhesion Molecule) • APOE (Apolipoprotein E) • PPARA (Peroxisome Proliferator Activated Receptor Alpha)
    |
    PTEN mutation
    |
    PredicineCARE™ • nCounter® PanCancer Immune Profiling Panel
    |
    Opdivo (nivolumab) • amezalpat (TPST-1120)
    almost2years
    A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (clinicaltrials.gov)
    P1/2, N=320, Recruiting, Hoffmann-La Roche | Trial completion date: Jul 2025 --> Dec 2025 | Trial primary completion date: Jul 2025 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • amezalpat (TPST-1120) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • muzastotug (ADG126) • tobemstomig (RG6139)
    2years
    Pharmacodynamic and predictive biomarkers associated with response in cancer patients treated with TPST-1120: a first-in-class, small molecule antagonist of Peroxisome-Proliferator Activated Receptor-Alpha (SITC 2022)
    Trial Registration TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers (NCT03829436). Patients with PR demonstrated gene expression changes that implicate immune activation and alleviation of immune suppression as potential biomarkers of clinical benefit. Increased frequencies of responding patients bearing PI3K pathway or IDH mutations may reveal populations likely to benefit from treatment with TPST-1120.
    Late-breaking abstract • PK/PD data • Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    PTEN (Phosphatase and tensin homolog) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • TNFRSF1A (TNF Receptor Superfamily Member 1A) • PVR (PVR Cell Adhesion Molecule) • FCGR2A (Fc fragment of IgG receptor IIa) • APOE (Apolipoprotein E) • ITGAX (Integrin Subunit Alpha X) • NCF4 (Neutrophil Cytosolic Factor 4) • PPARA (Peroxisome Proliferator Activated Receptor Alpha)
    |
    PTEN mutation
    |
    PredicineCARE™ • nCounter® PanCancer Immune Profiling Panel
    |
    Opdivo (nivolumab) • amezalpat (TPST-1120)
    over2years
    A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (clinicaltrials.gov)
    P1/2, N=320, Recruiting, Hoffmann-La Roche | Trial completion date: Dec 2024 --> Jul 2025 | Trial primary completion date: Dec 2024 --> Jul 2025
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • amezalpat (TPST-1120) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • tobemstomig (RG6139)
    over2years
    A phase 1 study of TPST-1120 as a single agent and in combination with nivolumab in subjects with advanced solid tumors. (ASCO 2022)
    TPST-1120 is a novel therapy designed to inhibit tumor proliferation and angiogenesis and stimulate anti-cancer immunity through inhibition of PPARα, a key regulator of FAO. The drug is well tolerated as a single agent and in combination with nivolumab. Promising objective responses have been observed in combination with nivolumab in subjects previously refractory to anti-PD-1 therapy, including 2/2 responders in late-line RCC, and a subject with heavily pretreated CCA, a tumor type generally not responsive to anti-PD-1 alone.
    Clinical • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    THBS1 (Thrombospondin 1) • PPARA (Peroxisome Proliferator Activated Receptor Alpha)
    |
    Opdivo (nivolumab) • amezalpat (TPST-1120)
    over2years
    A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (clinicaltrials.gov)
    P1/2, N=280, Recruiting, Hoffmann-La Roche | Trial completion date: Jul 2024 --> Dec 2024 | Trial primary completion date: Jul 2024 --> Dec 2024
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • amezalpat (TPST-1120) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • SAR439459 • tobemstomig (RG6139)
    over3years
    A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (clinicaltrials.gov)
    P1/2, N=280, Recruiting, Hoffmann-La Roche | Trial completion date: Oct 2024 --> Jul 2024
    Clinical • Trial completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • amezalpat (TPST-1120) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • SAR439459 • tobemstomig (RG6139)
    over3years
    A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (clinicaltrials.gov)
    P1/2, N=280, Recruiting, Hoffmann-La Roche | N=100 --> 280 | Trial completion date: Jul 2024 --> Oct 2024 | Trial primary completion date: Oct 2021 --> Jul 2024
    Clinical • Enrollment change • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • amezalpat (TPST-1120) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • SAR439459 • tobemstomig (RG6139)
    over4years
    A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver) (clinicaltrials.gov)
    P1/2; N=100; Recruiting; Sponsor: Hoffmann-La Roche
    New P1/2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • amezalpat (TPST-1120) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • SAR439459 • tobemstomig (RG6139)