GMI-1359 goes to Phase 1b

ROCKVILLE, Md.—GlycoMimetics, Inc. reported today that Duke University investigators have dosed the first patient in a proof-of-concept Phase 1b study meant to evaluate GlycoMimetics’ GMI-1359 drug candidate in patients with advanced breast cancer. The dose-escalating study will enroll up to 12 individuals with metastatic, hormone receptor positive breast cancer with stable or minimally progressive disease, including bone metastasis.

“The initiation of enrollment is an important milestone in our exploration of GMI-1359 and its potential as a novel approach to treating metastatic cancer,” said Helen Thackray, M.D., FAAP, senior vice president of Clinical Development and chief medical officer of GlycoMimetics. “We’re pleased to have such distinguished researchers at Duke University begin to explore the use of this investigational therapy and look forward to learning more about its potential impact as clinical study advances.”

GMI-1359 is designed to simultaneously inhibit E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow, such as acute myeloid leukemia and multiple myeloma; or in solid tumors that metastasize to the bone like prostate cancer and breast cancer, as well as in osteosarcoma.

Kelly Marcom, M.D., and Dorothy Sipkins, M.D., Ph.D., both of the Duke Cancer Institute, are the trial’s co-principal investigators. This clinical trial builds on published findings from Sipkins on the key roles of E-selectin and CXCR4 in the trafficking of metastatic cancer cells, and their establishment as micro-metastases in bone. Sipkins’ research suggests that both E-selectin and CXCR4 mediate key mechanisms that promote progression and migration of cancer cells to protective niches in the bone marrow micro-environment, and reveals the potential for an E-selectin and CXCR4 inhibitor like GMI-1359 to molecularly excise disseminated breast cancer cells.

GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. The newly initiated Phase 1b clinical study in breast cancer patients is designed to enable investigators to identify an effective dose of the drug candidate, and to generate initial biomarker data around the drug’s activity. The trial is designed to evaluate safety, pharmacokinetics and pharmacodynamic measures of biologic activity, such as increases in circulating tumor cells and mobilization of CD34+ and immune T-cell subsets. GlycoMimetics expects the trial results to be available in late 2020.