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Galecto Announces First Patient Dosed in an Investigator-Initiated Phase 2 Trial of GB1211 in Combination with PembrolizumabBOSTON, May 01, 2024 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company focused on the development of novel treatments for cancer and fibrosis, today announced that the first patient has been enrolled in an investigator-initiated Phase 2 trial to evaluate GB1211, Galecto’s first-in-class, oral small molecule galectin-3 inhibitor candidate, at the Earle A. Chiles Research Institute (EACRI), a division of Providence Cancer Institute in Portland, Oregon, USA. Under the direction of Providence investigators Dr. Brendan Curti and Dr. William Redmond, the study aims to evaluate the safety and efficacy of GB1211 at a dose of 100mg twice daily in combination with pembrolizumab for the treatment of metastatic malignant melanoma (MM) and head and neck squamous cell carcinoma (HNSCC). Drs. Curti and Redmond received an R01 Research Project Grant award from the National Cancer Institute, National Institutes of Health, for their investigator-initiated Phase 2 trial. Galecto has committed to supply GB1211 for the trial. Galectin-3 is overexpressed in many cancers, including melanoma and HNSCC. 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 can cause checkpoint inhibitor resistance by blocking the binding of the checkpoint inhibitor antibodies, pembrolizumab and atezolizumab (Tecentriq®), to their respective targets. Preclinical data has shown that GB1211 has the ability to reduce galectin-3 associated interference with immune checkpoint inhibition (ICI), thus alleviating galectin-3-specific ICI resistance. In the fourth quarter of 2023, Galecto reported topline results from its Phase 1b/2a GALLANT-1 clinical trial evaluating GB1211 twice daily in combination with atezolizumab for the first-line treatment of non-small cell lung cancer (NSCLC). Galecto reported that investigator-assessed objective tumor responses (defined as partial responses per RECIST criteria 1.1) were observed in three of five patients (60%) who received the recommended Phase 2 dose level of GB1211 100 mg for at least three weeks. Historically, 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 ICI. Dr. Brendan Curti, Medical Director, Providence Melanoma Program, and EACRI Member and Robert W. Franz Endowed Chair for Clinical Research, said, “Our ability to perform bench-bedside research is a great strength of the Providence Cancer Institute. The insights from Dr. Redmond’s lab about how to use galectin inhibitors to alter the tumor microenvironment and promote anti-tumor activity, as well as our initial observations in patients, provide a robust rationale for our phase II clinical trial in patients with melanoma and HNSCC.” Dr. William Redmond, Member and Director, EACRI Immune Monitoring Lab, and co-principal investigator for the trial, stated, “We have published a significant amount of data on the important role of galectin-3 in creating immune suppression within the tumor microenvironment. We are excited to start this study in melanoma and HNSCC patients to potentially counteract ICI resistance and increase the efficacy of ICI by combining GB1211 and pembrolizumab.” “We are excited that the Providence Cancer Institute and Drs. William Redmond and Brendan Curti have initiated this trial. Dr. Redmond is a world-leading expert on the role of galectin-3 in cancer and ICI resistance and has demonstrated how galectin inhibition can be used to enhance tumor treatment,” stated Dr. Hans Schambye, CEO of Galecto. “Following the encouraging topline results from the GALLANT-1 trial that we reported in the fourth quarter of 2023, we look forward to eploring potential synergies with another leading ICI, pembrolizumab. This new trial marks a significant stride towards exploring GB1211's potential to enhance the effectiveness of ICI in various cancer indications.” The randomized, double-blind placebo-controlled, investigator-initiated Phase 2 trial will evaluate whether the addition of GB1211 increases the response rate of pembrolizumab in metastatic melanoma and HNSCC patients. The study will employ a fixed dose of GB1211 in conjunction with the standard therapeutic dose of pembrolizumab in patients with unresectable or metastatic MM or recurrent or metastatic HNSCC progressing during or after platinum-containing chemotherapy. In addition to monitoring for toxicity and clinical response, biospecimens will be obtained to assess immunologic measures relevant to galectin biology and T-cell checkpoint inhibition. Tumor volume will be assessed by immune response RECIST criteria (iRECIST criteria 1.1). It is anticipated that early data from this trial could be available as early as 2025. About GB1211 and Galectin-3 Mechanisms in Cancer Preclinical data announced at the 2022 ASCO Annual Meeting furthermore 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 specifically designed to counter these anti-checkpoint inhibitor effects of galectin-3. 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. 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. About Providence Cancer Institute Forward-Looking Statements For more information, contact:
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