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    DRUG:

    Hepacid (pegargiminase)

    i
    Other names: ADI PEG20, ADI-SS PEG(20000), AD-PEG, ADI-PEG, ADI-PEG 20, ADI-SSPEG 20, ADI-SS PEG, ADI-PEG-20, ADI-PEG20
    Company:
    Er-Kim Pharma, Polaris Pharma
    Drug class:
    Arginine depleter
    19h
    Neoadjuvant ADI-PEG 20 + Ifosfamide + Radiotherapy in Soft Tissue Sarcoma (clinicaltrials.gov)
    P1, N=6, Active, not recruiting, Washington University School of Medicine | Phase classification: P1/2 --> P1 | N=35 --> 6 | Trial completion date: Jan 2029 --> Mar 2028 | Trial primary completion date: Jan 2027 --> Mar 2026 | Recruiting --> Active, not recruiting
    Enrollment closed • Phase classification • Enrollment change • Trial completion date • Trial primary completion date
    |
    ifosfamide • Hepacid (pegargiminase) • mesna
    2d
    ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers (clinicaltrials.gov)
    P1/2, N=31, Active, not recruiting, Washington University School of Medicine | N=114 --> 31 | Recruiting --> Active, not recruiting
    Enrollment closed • Enrollment change
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation
    |
    gemcitabine • docetaxel • Hepacid (pegargiminase)
    16d
    POLARIS2020-002: Study of ADI-PEG 20, Venetoclax and Azacitidine in Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=38, Active, not recruiting, Polaris Group | Trial completion date: Jul 2026 --> Dec 2026 | Trial primary completion date: Dec 2025 --> May 2026
    Trial completion date • Trial primary completion date
    |
    Venclexta (venetoclax) • azacitidine • Hepacid (pegargiminase)
    2ms
    Study of ADI-PEG 20 Versus Placebo in Subjects With High Arginine Level and Unresectable Hepatocellular Carcinoma (clinicaltrials.gov)
    P3, N=300, Recruiting, Polaris Group | Trial completion date: Oct 2025 --> Dec 2028 | Trial primary completion date: Sep 2025 --> Sep 2028
    Trial completion date • Trial primary completion date
    |
    Hepacid (pegargiminase)
    2ms
    Loss of Argininosuccinate Synthetase-1 (ASS1) Occurs in Esophageal Adenocarcinoma and Represents a Promising Biomarker for Therapy with Pegargiminase. (PubMed, Cancers (Basel))
    Background/Objectives: Despite the introduction of targeted therapies such as Nivolumab, survival outcomes for patients with esophageal adenocarcinoma remain poor. This underscores the urgent need for clinical trials evaluating the efficacy of pegargiminase in this patient population. Additionally, incorporating ASS1 immunohistochemical staining into pre-neoadjuvant biopsy assessments should be considered to optimize neoadjuvant treatment strategies and advance the implementation of personalized cancer therapy.
    Journal • PD(L)-1 Biomarker
    |
    ASS1 (Argininosuccinate synthase 1)
    |
    Opdivo (nivolumab) • Hepacid (pegargiminase)
    3ms
    POLARIS2020-002: Study of ADI-PEG 20, Venetoclax and Azacitidine in Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=38, Active, not recruiting, Polaris Group | Recruiting --> Active, not recruiting | N=60 --> 38 | Trial completion date: Dec 2025 --> Jul 2026 | Trial primary completion date: Jul 2025 --> Dec 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    Venclexta (venetoclax) • azacitidine • Hepacid (pegargiminase)
    4ms
    Neoadjuvant ADI-PEG 20 + Ifosfamide + Radiotherapy in Soft Tissue Sarcoma (clinicaltrials.gov)
    P1/2, N=35, Recruiting, Washington University School of Medicine | Trial completion date: Jan 2028 --> Jan 2029 | Trial primary completion date: Jan 2026 --> Jan 2027
    Trial completion date • Trial primary completion date
    |
    ifosfamide • Hepacid (pegargiminase) • mesna
    5ms
    Study of ADI-PEG 20 Versus Placebo in Subjects With NASH (clinicaltrials.gov)
    P2, N=60, Recruiting, Polaris Group | N=40 --> 60
    Enrollment change
    |
    Hepacid (pegargiminase)
    5ms
    ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Glioblastoma Multiforme (clinicaltrials.gov)
    P2, N=100, Active, not recruiting, Polaris Group | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    temozolomide • Hepacid (pegargiminase)
    6ms
    GBM AGILE: A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma (clinicaltrials.gov)
    P2/3, N=1280, Recruiting, Global Coalition for Adaptive Research | Trial completion date: Jun 2028 --> Jun 2030 | Trial primary completion date: Jun 2026 --> Jun 2028
    Trial completion date • Trial primary completion date
    |
    IDH wild-type
    |
    temozolomide • Stivarga (regorafenib) • lomustine • VT1021 • AZD1390 • Hepacid (pegargiminase) • paxalisib (GDC-0084) • dianhydrogalactitol (VAL-083) • Vyglxia (troriluzole)
    9ms
    ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers (clinicaltrials.gov)
    P1/2, N=114, Recruiting, Washington University School of Medicine | Trial completion date: Dec 2032 --> Dec 2033 | Trial primary completion date: Dec 2027 --> Dec 2028
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation
    |
    gemcitabine • docetaxel • Hepacid (pegargiminase)
    9ms
    Phase I/II Study of PEGylated Arginine Deiminase (ADI-PEG20) With Carboplatin and Cabazitaxel in Men With Aggressive Variant Prostate Cancers (AVPC) (clinicaltrials.gov)
    P1/2, N=30, Recruiting, M.D. Anderson Cancer Center | Active, not recruiting --> Recruiting
    Enrollment open
    |
    TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1)
    |
    TP53 mutation • PTEN mutation • LDH elevation
    |
    carboplatin • cabazitaxel • Hepacid (pegargiminase)