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    DRUG:

    Imprime PGG (odetiglucan)

    i
    Other names: BTH-1677, BTH1677, 1,3-1,6 beta glucan, soluble beta glucan, B-glucan PGG, PGG glucan, PGG beta-glucan
    Associations

    News

    Trials
    Company:
    HiberCell
    Drug class:
    Macrophage modulator, Dectin-1 agonist
    Related drugs:
    Associations

    News

    Trials
    2ms
    IGNITE: Maintenance Combinatorial Myeloid Immunotherapy for Unresectable Pancreatic Cancer (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, University of Pennsylvania
    New P2 trial
    |
    Imprime PGG (odetiglucan) • mitazalimab (ADC-1013)
    2ms
    Pembrolizumab and Odetiglucan in Liver Predominant Metastatic Colorectal Adenocarcinoma (clinicaltrials.gov)
    P2, N=27, Recruiting, Abramson Cancer Center at Penn Medicine | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • Imprime PGG (odetiglucan)
    4ms
    Pembrolizumab and Odetiglucan in Liver Predominant Metastatic Colorectal Adenocarcinoma (clinicaltrials.gov)
    P2, N=27, Not yet recruiting, Abramson Cancer Center at Penn Medicine
    New P2 trial
    |
    Keytruda (pembrolizumab) • Imprime PGG (odetiglucan)
    9ms
    Safety/Efficacy Study of Imprime PGG With Cetuximab in Patients With Recurrent/Progressive Colorectal Carcinoma (clinicaltrials.gov)
    P1/2, N=32, Completed, HiberCell, Inc. | Phase classification: P1b --> P1/2 | N=48 --> 32
    Phase classification • Enrollment change
    |
    Erbitux (cetuximab) • 5-fluorouracil • irinotecan • Imprime PGG (odetiglucan)
    over1year
    Pembrolizumab + Imprime PGG for Metastatic Non-small Cell Lung Cancer After Progression on First-Line Therapy: Big Ten Cancer Research Consortium BTCRC-LUN15-017 (clinicaltrials.gov)
    P1/2, N=35, Completed, Lawrence Feldman, MD | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    ALK (Anaplastic lymphoma kinase)
    |
    Keytruda (pembrolizumab) • Imprime PGG (odetiglucan)
    over1year
    A Maintenance Therapy Study of Odetiglucan With CDX-1140 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1, N=5, Terminated, HiberCell, Inc. | N=45 --> 5 | Trial completion date: Apr 2027 --> Mar 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Nov 2025 --> Mar 2024; sponsor decision
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Metastases
    |
    CDX-1140 • Imprime PGG (odetiglucan)
    over2years
    A Maintenance Therapy Study of Odetiglucan With a CD40 Agonist (CDX-1140) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1, N=45, Recruiting, HiberCell, Inc. | N=30 --> 45 | Trial completion date: Mar 2026 --> Apr 2027 | Trial primary completion date: Mar 2025 --> Nov 2025
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    CDX-1140 • Imprime PGG (odetiglucan)
    over2years
    Phase 2 Study of Imprime PGG and Pembrolizumab in Patients With HR+/HER2- Metastatic Breast Cancer (mBCA) (clinicaltrials.gov)
    P2, N=26, Completed, HiberCell, Inc. | Active, not recruiting --> Completed | N=50 --> 26 | Trial completion date: Jan 2027 --> Apr 2023 | Trial primary completion date: Jan 2025 --> Mar 2023
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • IO biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor) • CD86 (CD86 Molecule)
    |
    PIK3CA mutation
    |
    Keytruda (pembrolizumab) • Imprime PGG (odetiglucan)
    over2years
    A phase 1b, open-label, two-part safety, tolerability, and efficacy study of a soluble beta-glucan (odetiglucan) in combination with a CD40 agonistic monoclonal antibody (CDX-1140) in patients with metastatic pancreatic adenocarcinoma whose disease did not progress during first-line (1L) chemotherapy. (ASCO 2023)
    5 US sites will participate. Clinical trial information: NCT04834778.
    Clinical • P1 data • Combination therapy • Metastases
    |
    CD40 (CD40 Molecule)
    |
    CDX-1140 • Imprime PGG (odetiglucan)
    almost3years
    Phase 2 Study of Imprime PGG and Pembrolizumab in Patients With HR+/HER2- Metastatic Breast Cancer (mBCA) (clinicaltrials.gov)
    P2, N=50, Active, not recruiting, HiberCell, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • IO biomarker • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor) • CD86 (CD86 Molecule)
    |
    PIK3CA mutation
    |
    Keytruda (pembrolizumab) • Imprime PGG (odetiglucan)
    over3years
    Pembrolizumab + Imprime PGG for Metastatic Non-small Cell Lung Cancer After Progression on First-Line Therapy: Big Ten Cancer Research Consortium BTCRC-LUN15-017 (clinicaltrials.gov)
    P1/2, N=35, Active, not recruiting, Lawrence Feldman, MD | Trial completion date: Sep 2021 --> Oct 2025 | Trial primary completion date: Sep 2020 --> Jun 2022
    Trial completion date • Trial primary completion date
    |
    ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK mutation
    |
    Keytruda (pembrolizumab) • Imprime PGG (odetiglucan)
    over3years
    Imprime PGG Enhances Anti-Tumor Effects of Tumor-Targeting, Anti-Angiogenic, and Immune Checkpoint Inhibitor Antibodies. (PubMed, Front Oncol)
    Finally, Imprime treatment induced similar in vitro phenotypic and functional activation of human innate immune cells. Collectively, these data demonstrate Imprime's potential to orchestrate a broad, yet coordinated, anti-cancer immune response and complement existing cancer immunotherapies.
    Journal • Checkpoint inhibition • IO biomarker
    |
    CD8 (cluster of differentiation 8) • KDR (Kinase insert domain receptor) • CLEC7A (C-Type Lectin Domain Containing 7A) • TYRP1 (Tyrosinase Related Protein 1) • CD86 (CD86 Molecule)
    |
    Imprime PGG (odetiglucan)