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DRUG:

belapectin (GR-MD-02)

i
Other names: GR-MD-02, GR-MD02, GR MD 02
Associations
Company:
Galectin Therap
Drug class:
Galectin-3 inhibitor
Associations
2ms
NAVIGATE: Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis (clinicaltrials.gov)
P2/3, N=357, Terminated, Galectin Therapeutics Inc. | Trial completion date: Sep 2025 --> Apr 2025 | Active, not recruiting --> Terminated; Based on FDA feedback, Stage 1 of NAVIGATE was analyzed as a stand-alone trial. Study was not prematurely terminated for safety reasons.
Trial completion date • Trial termination
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belapectin (GR-MD-02)
3ms
Rewiring PD-1/PD-L1 combination therapy via glyco-immune targeting of galectins: Toward clinical translation. (PubMed, Biochim Biophys Acta Rev Cancer)
Several galectin inhibitors (e.g., GR-MD-02, GB1211, LYT-200) are under clinical evaluation. Early trials showing encouraging efficacy-toxicity profiles and some combinations received FDA Fast Track designations. This review summarizes mechanistic and clinical advances and highlights their translational implications for galectin-targeted combination therapies.
Review • Journal
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PD-L1 (Programmed death ligand 1)
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LYT-200 • belapectin (GR-MD-02) • selvigaltin (GB1211)
10ms
NAVIGATE: Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis (clinicaltrials.gov)
P2/3, N=357, Active, not recruiting, Galectin Therapeutics Inc. | Phase classification: P2b --> P2/3 | Trial completion date: Dec 2024 --> Sep 2025 | Trial primary completion date: Dec 2024 --> Mar 2025
Phase classification • Trial completion date • Trial primary completion date
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belapectin (GR-MD-02)
over2years
Enrollment change • Trial withdrawal • Metastases
|
CD8 (cluster of differentiation 8) • IL2RA (Interleukin 2 receptor, alpha) • CCR7 (Chemokine (C-C motif) receptor 7) • CD27 (CD27 Molecule) • LGALS3 (Galectin 3) • FAS (Fas cell surface death receptor) • FOXP3 (Forkhead Box P3) • ISG20 (Interferon Stimulated Exonuclease Gene 20)
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Keytruda (pembrolizumab) • belapectin (GR-MD-02)
over2years
GR-MD-02 Plus Pembrolizumab in Melanoma, Non-small Cell Lung Cancer, and Squamous Cell Head and Neck Cancer Patients (clinicaltrials.gov)
P1, N=36, Completed, Providence Health & Services | Active, not recruiting --> Completed | N=22 --> 36 | Trial completion date: May 2025 --> Oct 2022
Trial completion • Enrollment change • Trial completion date • Metastases
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BRAF (B-raf proto-oncogene) • CD4 (CD4 Molecule)
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Keytruda (pembrolizumab) • belapectin (GR-MD-02)
almost3years
GR-MD-02 + Pembrolizumab Versus Pembrolizumab Monotherapy in Melanoma and Squamous Cell Head and Neck Cancer Patients (clinicaltrials.gov)
P2, N=92, Suspended, Providence Health & Services | Trial completion date: Mar 2031 --> Jul 2031 | Trial primary completion date: Mar 2027 --> Jul 2027
Trial completion date • Trial primary completion date • Metastases
|
CD8 (cluster of differentiation 8) • IL2RA (Interleukin 2 receptor, alpha) • CCR7 (Chemokine (C-C motif) receptor 7) • CD27 (CD27 Molecule) • LGALS3 (Galectin 3) • FAS (Fas cell surface death receptor) • FOXP3 (Forkhead Box P3) • ISG20 (Interferon Stimulated Exonuclease Gene 20)
|
Keytruda (pembrolizumab) • belapectin (GR-MD-02)
3years
GR-MD-02 + Pembrolizumab Versus Pembrolizumab Monotherapy in Melanoma and Squamous Cell Head and Neck Cancer Patients (clinicaltrials.gov)
P2, N=92, Suspended, Providence Health & Services | Trial completion date: Dec 2030 --> Mar 2031 | Trial primary completion date: Dec 2026 --> Mar 2027
Trial completion date • Trial primary completion date • Metastases
|
CD8 (cluster of differentiation 8) • IL2RA (Interleukin 2 receptor, alpha) • CCR7 (Chemokine (C-C motif) receptor 7) • CD27 (CD27 Molecule) • LGALS3 (Galectin 3) • FAS (Fas cell surface death receptor) • FOXP3 (Forkhead Box P3)
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Keytruda (pembrolizumab) • belapectin (GR-MD-02)
3years
Galectin-1 and Galectin-3 in B-Cell Precursor Acute Lymphoblastic Leukemia. (PubMed, Int J Mol Sci)
Plant-derived carbohydrates GM-CT-01 and GR-MD-02 were used to inhibit extracellular Galectin-1/-3 binding to BCP-ALL cells in co-culture with stromal cells. Treatment with these compounds attenuated migration of the BCP-ALL cells to stromal cells and sensitized human BCP-ALL cells to vincristine and the targeted tyrosine kinase inhibitor nilotinib...Taken together, our results indicate a complicated joint contribution of Galectin-1 and Galectin-3 to BCP-ALL survival, with different roles for endogenous and stromal produced Galectins. These data indicate it will be important to efficiently block both extracellular and intracellular Galectin-1 and Galectin-3 with the goal of reducing BCP-ALL persistence in the protective bone marrow niche during chemotherapy.
Journal
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LGALS1 (Galectin 1) • LGALS3 (Galectin 3) • ST6GAL1 (ST6 Beta-Galactoside Alpha-2,6-Sialyltransferase 1)
|
nilotinib • vincristine • Davanat (galactomannan) • belapectin (GR-MD-02)
over3years
GR-MD-02 + Pembrolizumab Versus Pembrolizumab Monotherapy in Melanoma and Squamous Cell Head and Neck Cancer Patients (clinicaltrials.gov)
P2, N=92, Suspended, Providence Health & Services | Trial completion date: Aug 2030 --> Dec 2030 | Trial primary completion date: Aug 2026 --> Dec 2026
Trial completion date • Trial primary completion date
|
CD8 (cluster of differentiation 8) • IL2RA (Interleukin 2 receptor, alpha) • CCR7 (Chemokine (C-C motif) receptor 7) • CD27 (CD27 Molecule) • LGALS3 (Galectin 3) • FAS (Fas cell surface death receptor) • FOXP3 (Forkhead Box P3)
|
Keytruda (pembrolizumab) • belapectin (GR-MD-02)
over3years
GR-MD-02 Plus Pembrolizumab in Melanoma, Non-small Cell Lung Cancer, and Squamous Cell Head and Neck Cancer Patients (clinicaltrials.gov)
P1, N=22, Active, not recruiting, Providence Health & Services | Trial primary completion date: May 2022 --> May 2023
Trial primary completion date
|
BRAF (B-raf proto-oncogene) • CD4 (CD4 Molecule)
|
Keytruda (pembrolizumab) • belapectin (GR-MD-02)
almost4years
GR-MD-02 + Pembrolizumab Versus Pembrolizumab Monotherapy in Melanoma and Squamous Cell Head and Neck Cancer Patients (clinicaltrials.gov)
P2, N=92, Suspended, Providence Health & Services | Initiation date: Jan 2022 --> Jul 2022
Trial initiation date
|
CD8 (cluster of differentiation 8) • IL2RA (Interleukin 2 receptor, alpha) • CCR7 (Chemokine (C-C motif) receptor 7) • CD27 (CD27 Molecule) • LGALS3 (Galectin 3) • FAS (Fas cell surface death receptor) • FOXP3 (Forkhead Box P3)
|
Keytruda (pembrolizumab) • belapectin (GR-MD-02)
4years
GR-MD-02 Plus Pembrolizumab in Melanoma, Non-small Cell Lung Cancer, and Squamous Cell Head and Neck Cancer Patients (clinicaltrials.gov)
P1, N=22, Active, not recruiting, Providence Health & Services | Trial completion date: Oct 2021 --> May 2025 | Trial primary completion date: Oct 2021 --> May 2022
Trial completion date • Trial primary completion date
|
BRAF (B-raf proto-oncogene) • CD4 (CD4 Molecule)
|
Keytruda (pembrolizumab) • belapectin (GR-MD-02)