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Imprime PGG (odetiglucan)
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Other names: BTH-1677, BTH1677, 1,3-1,6 beta glucan, soluble beta glucan, B-glucan PGG, PGG glucan, PGG beta-glucan
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Company:
HiberCell
Drug class:
Macrophage modulator, Dectin-1 agonist
Related drugs:
4ms
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)
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Keytruda (pembrolizumab) • Imprime PGG (odetiglucan)
9ms
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
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CDX-1140 • Imprime PGG (odetiglucan)
over1year
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)
over1year
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)
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PIK3CA mutation
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Keytruda (pembrolizumab) • Imprime PGG (odetiglucan)
over1year
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
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CD40 (CD40 Molecule)
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CDX-1140 • Imprime PGG (odetiglucan)
almost2years
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)
over2years
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
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ALK (Anaplastic lymphoma kinase)
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EGFR mutation • ALK mutation
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Keytruda (pembrolizumab) • Imprime PGG (odetiglucan)
over2years
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
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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)
3years
Phase 2 Study of Imprime PGG and Pembrolizumab in Patients With HR+/HER2- Metastatic Breast Cancer (mBCA) (clinicaltrials.gov)
P2, N=50, Recruiting, HiberCell, Inc.
New P2 trial • IO biomarker
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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)
3years
A multicenter, open-label, phase 2 study of Imprime PGG and pembrolizumab in patients with metastatic breast cancer who have progressed through prior hormonal therapy (SABCS 2021)
For information, contact Nick Niles nniles@hibercell.com . 612.230.5846.
Clinical • P2 data
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HER-2 (Human epidermal growth factor receptor 2)
|
PD-L1 expression • HR positive • HER-2 negative
|
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 primary completion date: Apr 2021 --> Sep 2020
Clinical • Trial primary completion date
|
ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK mutation
|
Keytruda (pembrolizumab) • Imprime PGG (odetiglucan)
over3years
Study of Imprime PGG and Pembrolizumab in Advanced Melanoma and Triple Negative Breast Cancer (clinicaltrials.gov)
P2, N=64, Completed, Biothera | Active, not recruiting --> Completed | Trial completion date: Nov 2021 --> Dec 2020 | Trial primary completion date: Apr 2019 --> Dec 2020
Clinical • Trial completion • Trial completion date • Trial primary completion date • Checkpoint inhibition
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 negative
|
Keytruda (pembrolizumab) • Imprime PGG (odetiglucan)
4years
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 | Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2020 --> Apr 2021
Clinical • Enrollment closed • Trial primary completion date
|
ALK (Anaplastic lymphoma kinase)
|
EGFR mutation • ALK mutation
|
Keytruda (pembrolizumab) • Imprime PGG (odetiglucan)
over4years
[VIRTUAL] IMPRIME 1 (NCT02981303): A novel phase 2 study in second-line +, metastatic triple negative breast cancer patients shows promising clinical benefit for the combination of the immune checkpoint inhibitor, pembrolizumab (pembro), with the novel innate immune activator, Imprime PGG (AACR-I 2020)
IMPRIME 1 provides clinical and molecular/ cellular proof of concept data for the combination of Imprime and pembro. These promising data support additional clinical studies in mTNBC pts for this novel Immuno-onocology combination.
Clinical • P2 data • Checkpoint inhibition
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • Imprime PGG (odetiglucan)
5years
Response and clinical benefit assessment of the combination of the Dectin-1 agonist Imprime PGG and anti-PD-1 Pembrolizumab in chemotherapy-resistant metastatic triple negative breast cancer (TNBC) (SABCS 2019)
The combination of Imprime and Pembro provides promising response rates and overall survival in chemo-refractory metastatic TNBC. Biopsy analyses consistently showed activation of both myeloid and T cells with extensive infiltration into tumor tissue. Examination of response patterns and clinical benefit revealed extended OS even in pts not classified as responders by RECIST.
Clinical
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PD-1 (Programmed cell death 1)
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Keytruda (pembrolizumab) • Imprime PGG (odetiglucan)
over6years
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Colorectal Cancer (Morpheus-CRC) (clinicaltrials.gov)
P1/2; N=120; Not yet recruiting; Sponsor: Hoffmann-La Roche
New P1/2 trial
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Avastin (bevacizumab) • Tecentriq (atezolizumab) • Stivarga (regorafenib) • Sarclisa (isatuximab-irfc) • idasanutlin (RG7388) • etrumadenant (AB928) • Imprime PGG (odetiglucan) • delolimogene mupadenorepvec (LOAd703) • selicrelumab (RG7876)
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