Galecto, Inc. 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.

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.