^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    selvigaltin (GB1211)

    i
    Other names: GB1211, GB 1211, GB-1211
    Associations

    News

    Trials
    Company:
    Galecto
    Drug class:
    Galectin-3 inhibitor
    Related drugs:
    Associations

    News

    Trials
    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
    |
    PD-L1 (Programmed death ligand 1)
    |
    LYT-200 • belapectin (GR-MD-02) • selvigaltin (GB1211)
    5ms
    Selvigaltin With Standard of Care Treatment for the Treatment of Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=21, Not yet recruiting, Roswell Park Cancer Institute | Trial completion date: Sep 2028 --> Feb 2028 | Initiation date: Oct 2025 --> Feb 2026 | Trial primary completion date: Sep 2027 --> Feb 2028
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    carfilzomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Hemady (dexamethasone tablets) • selvigaltin (GB1211)
    7ms
    Selvigaltin With Standard of Care Treatment for the Treatment of Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=21, Not yet recruiting, Roswell Park Cancer Institute
    New P1 trial
    |
    carfilzomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Hemady (dexamethasone tablets) • selvigaltin (GB1211)
    over1year
    Relative bioavailability and food effect of the galectin-3 inhibitor selvigaltin (GB1211) administered as a tablet in healthy participants (GALBA-1). (PubMed, Cancer Chemother Pharmacol)
    The tablet formulation of selvigaltin displayed higher bioavailability vs. the capsule formulation, with minimal effect of food on PK. Selvigaltin was well-tolerated during all treatments. These findings warrant further clinical development of the tablet formulation of selvigaltin without specific food restrictions.
    Journal
    |
    LGALS3 (Galectin 3)
    |
    selvigaltin (GB1211)
    almost2years
    GALLANT-1: A Study to Investigate the Safety and Efficacy of GB1211 (a Galectin-3 Inhibitor) in Combination With Atezolizumab in Patients With Non-Small Cell Lung Cancer (NSCLC). (clinicaltrials.gov)
    P1/2; Recruiting --> Active, not recruiting | Trial completion date: Apr 2024 --> Nov 2025 | Trial primary completion date: Jul 2023 --> May 2024
    Combination therapy • Trial completion date • Trial primary completion date • Enrollment closed
    |
    PD-L1 (Programmed death ligand 1) • LGALS3 (Galectin 3)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    Tecentriq (atezolizumab) • selvigaltin (GB1211)
    almost2years
    GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=92, Recruiting, Providence Health & Services | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    LGALS3 (Galectin 3)
    |
    Keytruda (pembrolizumab) • selvigaltin (GB1211)
    2years
    GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=92, Not yet recruiting, Providence Health & Services | Trial completion date: Dec 2030 --> Feb 2030 | Trial primary completion date: Dec 2028 --> Feb 2028
    Trial completion date • Trial primary completion date • Metastases
    |
    LGALS3 (Galectin 3)
    |
    Keytruda (pembrolizumab) • selvigaltin (GB1211)
    2years
    GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=92, Not yet recruiting, Providence Health & Services
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    LGALS3 (Galectin 3)
    |
    Keytruda (pembrolizumab) • selvigaltin (GB1211)
    over2years
    GALLANT-1: GB1211 galectin-3 (Gal-3) inhibitor plus atezolizumab (atz) for first line treatment in patients (pts) with advanced/metastatic non-small cell lung cancer (NSCLC) (ESMO 2023)
    Conclusions This is the first clinical study to show that combining GB1211 with atz may enhance the CPI effect. As the AEs have been manageable, Part A will continue with the 100 mg GB1211 dose to confirm the selected dose for Part B.
    Clinical • PD(L)-1 Biomarker • Metastases
    |
    LGALS3 (Galectin 3)
    |
    Tecentriq (atezolizumab) • selvigaltin (GB1211)
    over2years
    GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=92, Not yet recruiting, Providence Health & Services
    New P2 trial • 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) • selvigaltin (GB1211)
    over3years
    GALLANT-1: Galectin-3 (Gal-3) inhibitor, GB1211, plus atezolizumab (atz) in patients (pts) with non-small cell lung cancer (NSCLC) - a dose finding study followed by a randomised, double-blind, placebo-controlled trial (ESMO 2022)
    In retrospective studies, pts with stage IV NSCLC and high Gal-3 levels have been shown to be resistant to pembrolizumab, despite >50% programmed death-ligand 1 (PD-L1) staining (Capalbo 2019), and pts with resected stage II/IIIA NSCLC and high Gal-3 were shown to be resistant to chemotherapy (Kusuhara 2021). Part C is an open-label extension study including pts from Parts A and B, with safety and efficacy assessments. The study has been initiated and is recruiting.
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • LAG3 (Lymphocyte Activating 3) • LGALS3 (Galectin 3)
    |
    PD-L1 expression • KRAS mutation • KRAS overexpression
    |
    Keytruda (pembrolizumab) • Tecentriq (atezolizumab) • selvigaltin (GB1211)
    over3years
    Resistance to anti-PD-1/anti-PD-L1: GB1211 reverses galectin-3 induced blockade of pembrolizumab and atezolizumab binding to PD-1/PD-L1 (EACR 2022)
    Conclusion These findings agree with in vivo & clinical data showing an association between Gal-3 expression & lack of efficacy of PD1/PDL1 targeted checkpoint inhibitors. 1 Li et al Biomedicines 2021 2 Capalbo et al Int J Mol Sci 2019 3 Vuong et al Cancer Res 2019 4 Zhang et al FEBS Open Bio 2020
    PD(L)-1 Biomarker • IO biomarker
    |
    LGALS3 (Galectin 3)
    |
    PD-L1-H
    |
    Keytruda (pembrolizumab) • Tecentriq (atezolizumab) • selvigaltin (GB1211)