Collaborations

Corporate Collaboration Partners:

In January 2020, we signed an exclusive collaboration and license agreement with Apollomics for the development and commercialization of uproleselan and GMI-1687 in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China. Under the terms of the agreement, Apollomics will be responsible for clinical development and commercialization in Greater China. The companies will also collaborate to advance the preclinical and clinical development of GMI-1687, a highly potent, subcutaneous E-selectin antagonist with broad clinical potential. Subject to the terms of the agreement, GlycoMimetics received an upfront cash payment of $9 million and will be eligible to receive potential milestone payments totaling approximately $180 million, as well as tiered royalties on net sales. Apollomics will be responsible for all costs related to development, regulatory approvals, and commercialization activities for uproleselan and GMI-1687 in Greater China. GlycoMimetics retains all rights for both compounds in the rest of the world.

Clinical Collaboration Partners:

In May 2018, we signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). Under the terms of the CRADA, we will collaborate with both the NCI and the Alliance for Clinical Trials in Oncology to conduct a randomized, controlled clinical trial testing the addition of uproleselan to a standard Cytarabine/Daunorubicin regimen (7&3) in older adults with previously untreated AML who are eligible for intensive chemotherapy. The primary endpoint will be overall survival, with a planned interim analysis based on event-free survival (EFS) after the first 262 patients have been enrolled in the study. Under the terms of the CRADA, the NCI may fund additional research, including clinical trials of pediatric patients with AML as well as preclinical experiments and clinical trials evaluating alternative chemotherapy regimens. We will supply uproleselan and provide financial support to augment data analysis and monitoring for the Phase 3 program.

Clinically unapparent bone marrow (BM) micrometastases are present at the time of diagnosis in many patients with early-stage breast cancer. These micrometastases can survive in the face of adjuvant therapy and lay dormant for years before they become proliferative, causing overt and incurable metastatic bone disease. Evidence suggests that the BM microenvironment protects these cells from apoptosis during this period of dormancy. In collaboration with the team at the Duke University’s Duke Cancer Institute, we are assessing the ability of GMI-1359, a dual function CXCR4/E-selectin antagonist, to mobilize these dormant cancer cells into the blood and retain there for extended periods of time, where they will become vulnerable to programmed cell death or cytotoxic, hormonal and/or immune therapies. A Phase Ib study of GMI-1359 in high risk, breast cancer patients with persistent bone micrometastases is currently ongoing. This statement does not constitute an endorsement of any GlycoMimetics’ commercial product or service by Duke University, Duke University’s Duke Cancer Institute or Principal Investigator at Duke University who is directing the conduct of this study.

Siteman Cancer Center, based at Barnes-Jewish Hospital and Washington University School of Medicine, is a top-ranked National Cancer Institute (NCI)-designated Comprehensive Cancer Center and recently received the NCI’s highest possible rating of “Exceptional” for its research programs. In May 2021, GlycoMimetics announced that clinicians at Washington University School of Medicine in St. Louis dosed the first patient in an investigator-sponsored trial (IST) evaluating uproleselan as a prophylactic agent to reduce gastrointestinal (GI) toxicities and improve clinical outcomes in patients receiving high-dose melphalan in autologous hematopoietic cell transplantation (auto-HCT) for multiple myeloma. Dr. Keith Stockerl-Goldstein, M.D., Professor of Medicine, Division of Oncology, Section of Bone Marrow Transplantation, Washington University School of Medicine, is the clinical trial’s principal investigator.

In July 2021, GlycoMimetics announced that clinicians at University of California (UC) Davis Comprehensive Cancer Center initiated dosing of the first patient in a clinical study of uproleselan combined with venetoclax and azacitidine for the treatment of older or unfit patients with treatment-naïve acute myeloid leukemia (AML). Brian A. Jonas, MD, PhD, FACP, UC Davis Division of Hematology/Oncology, is the clinical trial’s principal investigator. The UC Davis Comprehensive Cancer Center study is an investigator-sponsored trial (IST) for which GlycoMimetics is providing uproleselan. Designed to evaluate the safety and efficacy of the triple combination, the study is non-randomized, open label and multi-center. The goal of the two-part trial is first to determine a recommended Phase 2 dose, and then to explore efficacy in a dose expansion cohort.

In July 2021, GlycoMimetics announced that clinicians treated the first patient in a Phase 1b/2 study evaluating uproleselan added to cladribine plus low dose cytarabine (LDAC) in patients with treated secondary AML (ts‐AML). The investigator‐sponsored trial is being led by Tapan Kadia, M.D., associate professor of Leukemia at The University of Texas MD Anderson Cancer Center. GlycoMimetics is providing uproleselan for the investigator‐sponsored trial. The study is designed to evaluate both the safety and tolerability of the combination therapy, as well as to identify a recommended Phase 2 dose of the uproleselan triple combination approach in patients with ts‐AML. Among the trial’s secondary objectives are efficacy assessments including overall response rate and the rate of minimal residual disease negativity evaluated by flow cytometry at response.

Preclinical Collaboration Partners:

We have had a longstanding partnership with Mater Research Institute—The University of Queensland (MRI-UQ) that provides support of their translational research activities aimed at elucidating the role of E-selectin within the bone marrow microenvironment. Through this collaboration, we have shown that E-selectin plays a crucial role within the vascular niche regulating hematopoietic stem cell dormancy, self-renewal and chemoresistance (Nature Medicine, 2012) and that by antagonizing E-selectin with uproleselan, leukemic stem cells can be sensitized to chemotherapy, potentially improving clinical outcomes for patients.

We have had a longstanding research collaboration with the University of Washington/Fred Hutchinson Cancer Research Center that provides support for both nonclinical and clinical studies directed at defining pathways of cell adhesion mediated chemoresistance in AML. Through this collaboration, we have identified several biomarkers of chemoresistance that may prove to be particularly useful to guide the clinical development of uproleselan.

Since 2015, we have had an ongoing research collaboration with Dr. Michael Andreeff, Professor of Medicine, Department of Leukemia, Division of Cancer Medicine, at The University of Texas MD Anderson Cancer Center, directed at understanding the role of uproleselan and GMI-1359 on micro-environment-mediated drug resistance. Through this collaboration, we have a greater understanding of the mechanism of action for our drug candidates and have identified strategies to disrupt underlying environmental-mediated resistant mechanisms and augment the anti-leukemic effects of chemotherapy in AML, including in patients with FLT3-ITD mutations.