The initiation of GALLANT-1 continues Galecto’s strategy to treat cancer and fibrotic diseases through developing targeted therapeutics. Galectin-3, the target of GB1211, is elevated in many cancers. Increased galectin-3 expression in tumors is linked to tumor growth, invasiveness and metastatic potential. Furthermore, increased levels of galectin-3 in the tumor microenvironment facilitates tumor escape from the immune response by suppressing essential T-cell functions and activating tumor-protecting macrophages. Clinical evidence from patients with NSCLC suggests that high levels of galectin-3 in tumors leads to resistance to treatment with checkpoint inhibitors. In multiple pre-clinical models, including NSCLC, GB1211 has been shown to reduce tumor growth and metastasis and increase efficacy of checkpoint inhibition.
“As a leader in developing therapies using galectin inhibitors, we are very excited about the potential use of our proprietary compounds in difficult-to-treat cancers. GB1211 has been shown to be a well-tolerated, potent inhibitor of galectin-3 with the potential to act as a monotherapy in solid tumors and enhance checkpoint inhibitor therapies,” said Dr Hans Schambye, CEO of
The Phase 2a trial of GB1211 in combination with Tecentriq® will be a 1:1 randomized, double blind, placebo-controlled trial in patients with NSCLC in the first line setting. Part A of GALLANT-1 will be an open-label stage in 8-12 patients to select the dose of GB1211 (200mg or 400mg twice daily) to be used with Tecentriq®. Part B will evaluate safety and tumor shrinkage in up to 75 patients; additionally, it will explore tumor response rate based on RECIST criteria, clinical activity and immune biomarkers.
About GB1211 and Galectin-3 Mechanisms in Cancer
Increased galectin-3 expression in tumors is linked to tumor growth, invasiveness and metastatic potential. In the tumor tissue, galectin-3 supports the creation of fibrosis, tumor proliferation, metastasis, and immune avoidance. Galectin-3 uses a host of mechanisms including, but not limited to, VEGF, TGF-β, TYRO3, and
Further, recent data announced at the 2022 ASCO Annual Meeting suggest that galectin-3 can enhance PD-1 and PD-L1 binding and avert the interference of anti-PD-1/anti-PD-L1 therapies by blocking the binding of the antibodies to their respective targets. GB1211 is designed to counter these effects.
GB1211 demonstrated an anti-cancer effect and antifibrotic activity in multiple preclinical models and has successfully completed a Phase 1 trial in 78 healthy volunteers. In the Phase 1 trial, GB1211 was well-tolerated and exhibited dose-dependent pharmacokinetics. The mechanism of action is specific inhibition of the carbohydrate recognition domain of galectin-3.
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the potential safety and efficacy of GB1211 in combination with atezolizumab (Tecentriq®); the timing of initiating clinical trials and providing topline data for Galecto’s product candidates, including GB1211 in NSCLC; and Galecto’s focus and plans for clinical development of its product candidates and pipeline. Such forward-looking statements include statements about Galecto’s focus, plans for clinical development, product candidates and pipeline. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. For such statements,
For more information, contact:
Hans Schambye, CEO
Jon Freve, CFO
+45 70 70 52 10
Ashley R. Robinson
+1 617 430 7577
Sandya von der Weid
+41 78 680 0538