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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
    8d
    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)
    24d
    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)
    2ms
    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)
    2ms
    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)
    3ms
    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)
    4ms
    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)
    7ms
    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)
    7ms
    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)
    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=5, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=30 --> 5
    Enrollment closed • Enrollment change
    |
    TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1)
    |
    TP53 mutation • PTEN mutation • LDH elevation
    |
    carboplatin • cabazitaxel • Hepacid (pegargiminase)
    10ms
    Bcl-Xl Protects ASS1-Deficient Cancers From Arginine Starvation Induced Apoptosis. (PubMed, Clin Cancer Res)
    The study identifies Bcl-xL as a key factor limiting the efficacy of arginine starvation therapies. Combining Bcl-xL inhibitors with arginine deprivation strategies may overcome this resistance and enhance therapeutic outcomes. These findings provide a strong preclinical rationale for testing this combination approach in Phase 1 clinical trials for ASS1-deficient cancers.
    Journal • PARP Biomarker
    |
    MCL1 (Myeloid cell leukemia 1) • BCL2L1 (BCL2-like 1) • ASS1 (Argininosuccinate synthase 1)
    |
    Hepacid (pegargiminase)
    1year
    ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects with Glioblastoma Multiforme (clinicaltrials.gov)
    P2, N=100, Recruiting, Polaris Group | Phase classification: P1b --> P2 | N=32 --> 100
    Phase classification • Enrollment change
    |
    temozolomide • Hepacid (pegargiminase)
    over1year
    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 | Trial completion date: Sep 2027 --> Dec 2027
    Trial completion date
    |
    TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1)
    |
    carboplatin • cabazitaxel • Hepacid (pegargiminase)