GLTO - Galecto Presents Updated Clinical Data at ESMO Congress 2023 and Provides Update on Phase 1b/2a GALLANT-1 Trial | Benzinga
BOSTON, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ:GLTO), a clinical-stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today presented a poster with new and encouraging clinical data, including two additional partial responders, from the dose-finding Part A of its Phase 1b/2a trial (NCT05240131) (the GALLANT-1 trial) at the European Society of Medical Oncology (ESMO) Congress 2023 in Madrid, Spain. The GALLANT-1 trial is designed to study the combination of atezolizumab (Tecentriq®) and GB1211, Galecto's first-in-class, oral small-molecule galectin-3 inhibitor candidate, in the first-line treatment of patients with metastatic/advanced non-small cell lung cancer (NSCLC).
At the recommended Phase 2 dose level of 100 mg GB1211 twice daily, investigator-assessed objective tumor responses (defined as partial responses per RECIST criteria 1.1) were observed in three of five patients (60%) who received GB1211 for at least three weeks. Response rates of only 22–38% have been observed with atezolizumab monotherapy in the first-line treatment of advanced NSCLC, suggesting a potential benefit of adding GB1211 to atezolizumab. The Company believes that GALLANT-1 is the first clinical trial to show that combining an oral galectin-3 inhibitor with a checkpoint inhibitor may enhance the effect of checkpoint inhibitors.
In addition, insights from early biomarker analyses revealed a trend showing that responders had increased levels of galectin-3 at baseline, and stable or decreasing galectin-3 levels during treatment. In contrast, patients with progressive disease demonstrated increasing levels of galectin-3 during treatment. This correlation suggests that the detection of galectin-3 levels could potentially be used to select and monitor patient populations.
Overall, the combination of GB1211 100 mg and atezolizumab appeared to be well-tolerated, with predominantly Grade 1 and Grade 2 treatment emergent adverse effects observed. At the 200 mg twice daily dose-level, two severe dose-limiting skin reactions were observed that may indicate lymphocyte activation in line with the GB1211 mode of action, which resulted in a reduction to the 100 mg GB1211 dose level. Importantly, these skin rashes were not observed at the recommended Phase 2 dose level of 100 mg GB1211 twice daily.
As part of Galecto's recently announced strategic alternative process, Galecto has determined that it will not initiate Part B of the GALLANT-1 trial and will instead reallocate ...