First Patient Enrolls in Phase 2 GB1211-Pembrolizumab Trial

A clinical-stage biotechnology firm, Galecto, Inc., has initiated a Phase 2 study at the Earle A. Chiles Research Institute, part of the Providence Cancer Institute in Portland, Oregon. This study is focused on the evaluation of GB1211, an oral galectin-3 inhibitor, in combination with pembrolizumab (Keytruda®), for the treatment of patients with metastatic melanoma and head and neck squamous cell carcinoma.

Galecto's GB1211 is a novel oral small molecule that inhibits galectin-3, a protein often overexpressed in various cancers and associated with tumor growth and resistance to checkpoint inhibitors. The study, led by Providence investigators Dr. Brendan Curti and Dr. William Redmond, will assess the safety and efficacy of GB1211 at a dosage of 100mg twice daily in combination with pembrolizumab. The investigators have received an R01 Research Project Grant from the National Cancer Institute, National Institutes of Health, for this trial, and Galecto has committed to providing GB1211 for the study.

Preclinical data indicates that GB1211 can reduce galectin-3's interference with immune checkpoint inhibition, potentially alleviating resistance to checkpoint inhibitors such as pembrolizumab and atezolizumab (Tecentriq®). In the fourth quarter of 2023, Galecto reported positive results from the Phase 1b/2a GALLANT-1 clinical trial, which evaluated GB1211 in combination with atezolizumab for the first-line treatment of non-small cell lung cancer (NSCLC). The trial observed a 60% objective tumor response rate among patients who received the recommended Phase 2 dose level of GB1211, compared to historical response rates of 22–38% with atezolizumab monotherapy.

Dr. Curti, Medical Director of Providence Melanoma Program, highlighted the strength of the Providence Cancer Institute in bench-bedside research and the rationale for the phase II clinical trial based on insights from Dr. Redmond's lab. Dr. Redmond, Director of EACRI Immune Monitoring Lab, expressed excitement about the study's potential to counteract ICI resistance and increase the efficacy of ICI by combining GB1211 with pembrolizumab.

Dr. Hans Schambye, CEO of Galecto, emphasized Dr. Redmond's expertise in galectin-3's role in cancer and ICI resistance and the potential synergies with pembrolizumab following the GALLANT-1 trial's encouraging results. The Phase 2 trial is a randomized, double-blind, placebo-controlled study designed to determine if GB1211 enhances the response rate of pembrolizumab in metastatic melanoma and HNSCC patients. The study will also collect biospecimens to assess immunologic measures relevant to galectin biology and T-cell checkpoint inhibition. Early data from the trial is expected to be available by 2025.

Galecto is developing small molecule inhibitors of galectin-3 and LOXL2, with multiple Phase 2 clinical opportunities in fibrosis and cancer, including GB2064 for myelofibrosis and GB1211 for liver cirrhosis, as well as in combination with checkpoint inhibitors for various oncology indications. The Providence Cancer Institute is renowned for its cancer services, research, and leadership in cancer immunotherapy since 1993.