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Galecto Announces First Patient Enrolled in Phase 2 Trial of GB1211 in Combination with Atezolizumab for First-Line Treatment of NSCLCBOSTON, June 16, 2022 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that the first patient has been enrolled in the Phase 2a GALLANT-1 trial (NCT05240131). GALLANT-1 is designed to study the combination of GB1211, Galecto’s oral small molecule galectin-3 inhibitor, with Roche’s PD-L1 checkpoint inhibitor, atezolizumab (Tecentriq®), for the first-line treatment of non-small cell lung cancer (NSCLC). Galecto anticipates topline data from GALLANT-1 in mid-2023. 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 Galecto. “Starting in the first-line treatment of NSCLC opens the door for Galecto to pursue numerous oncology opportunities.” 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. Galecto is the sponsor of the study and Roche will provide clinical supply of Tecentriq®. Galecto retains all rights to GB1211 globally. About GB1211 and Galectin-3 Mechanisms in Cancer 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. About Galecto Galecto intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit www.galecto.com. Forward-Looking Statements For more information, contact:
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