GMI-1359 is a rationally-designed small-molecule that simultaneously targets both E-selectin and a chemokine receptor known as CXCR4. The chemokine CXCR4 has emerged as an important pro-inflammatory cytokine that is involved in cell migration throughout the body. Like E-selectin, tumor cells may also use the CXCR4 cellular pathway, contributing to chemoresistance, metastatic disease and ultimately decreased survival. We believe that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that affect the bone marrow, such as hematologic cancers and certain solid tumors, such as breast and prostate cancer, as compared to targeting CXCR4 alone.
Recent scientific publications and presentations with GMI-1359 include the following:
- In a paper published in Science Translational Medicine in May 2016, researchers at Duke University—together with GlycoMimetics scientists—demonstrated the key roles of both E-selectin and CXCR4 in trafficking of breast cancer cells to bone marrow.
- At the ASH annual meeting in December 2016, we presented preclinical data suggesting that GMI-1359 has a unique tumor cell mobilization profile and enhanced the ability of chemotherapy to target and improve survival from a high-risk form of mutated AML.
- In November 2016, at the annual meeting of the Society for Immunotherapy of Cancer, we presented data from a preclinical study in which GMI-1359, in combination with an antibody against the cancer regulatory programmed death receptor ligand, or PD-L1, shortened time to complete tumor regressions in an animal model of colon cancer. In the preclinical study, the combination therapy also selectively reduced regulatory T cells, which are a class of lymphocytes that suppress immune responses, in the tumor, and created a more favorable immune-mediated anti-tumor environment.
GMI-1359 is currently being evaluated in a Phase 1 single-dose escalation trial in healthy volunteers. In this trial, volunteer participants receive a single injection of GMI-1359, after which they are evaluated for safety, tolerability, PK and pharmacodynamics. The randomized, double-blind, placebo-controlled, escalating dose study is being conducted at a single site in the United States. The company expects during 2018 to announce an indication for which it will develop this candidate.
GMI-1359 has not approved for use by any health authority anywhere in the world.