Benzinga | Nov 2, 2021 10:54AM EDT

Galecto Announces Clinical Collaboration With Roche For Phase 2 Trial Of GB1211 In Combination With Atezolizumab In First Line Non-Small-Cell Lung Cancer

Galecto, Inc. (NASDAQ:GLTO), a publicly listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced that it has entered into a clinical trial supply agreement with Roche to explore the combination of GB1211, Galecto's oral galectin-3 inhibitor, with Roche's PD-L1 checkpoint inhibitor atezolizumab (Tecentriq(r)) in Galecto's planned Phase 2a trial in non-small-cell lung cancer (NSCLC). Galectin-3 has been identified as the guardian of the tumor microenvironment, driving cancer growth and allowing tumor cells to escape the immune mediated attack through the activation of, among other things, LAG-3. Galecto's planned NSCLC trial marks the first opportunity to demonstrate the anti-cancer effects of a potent and selective oral galectin-3 inhibitor.

Under the terms of the agreement, Galecto will fund and conduct a Phase 2a clinical trial to investigate the combination of GB1211, Galecto's potent and selective oral small molecule galectin-3 inhibitor, and Tecentriq for the treatment of first line NSCLC.

"Our galectin-3 asset, GB1211, has shown compelling anti-cancer effects in preclinical models, specifically in NSCLC tumors high in galectin-3 and resistant to anti-PD-1/-L1," said Dr. Hans Schambye, CEO of Galecto. "Galectin-3 inhibition has the potential to increase both T-cell function as a single agent and the efficacy of check-point inhibitors in NSCLC patients with high galectin-3 expression. We look forward to initiating our phase 2a combination study of GB1211 in NSCLC during the first half of 2022 and anticipate topline data from this trial in mid-2023."

Dr. Schambye continued, "This phase 2a trial of GB1211 further expands our scope into oncology. Many cancers use galectin-3 to avoid immune recognition through interaction with LAG-3, TGF-?, interferon gamma and K-Ras. We have shown that GB1211 is able to counter these effects and increase check-point inhibitor efficacy in cancer models. Therefore, we believe that our galectin-3 inhibitors could represent a new and exciting option to treat cancer with a low level of toxicity."

The phase 2a trial of GB1211 in combination with Tecentriq will be a 1:1 randomized, double blind, placebo-controlled trial in up to 70 patients with NSCLC in the first line setting. The trial is designed to evaluate safety and tumor shrinkage; additionally, it will explore RECIST tumor response, clinical activity and immune biomarkers. Galecto will be the sponsor of the study and Roche will provide clinical supply of Tecentriq. Galecto currently retains all rights to GB1211.