Collaborations

Corporate Collaboration Partners:

In January 2020, GlycoMimetics 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. For further details on this collaboration, see Apollomics Collaboration Press Release.

 

Clinical Collaboration Partners:

In May 2018, GlycoMimetics 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 acute myeloid leukemia (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. The Phase 2 portion of this study is fully enrolled and awaiting readout of the interim analysis of EFS. 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.

 

In December 2022, initial results of an investigator-initiated clinical study of uproleselan combined with venetoclax and azacitidine for the treatment of older or unfit patients with treatment-naïve acute myeloid leukemia (AML) were presented at the American Society of Hematology (ASH) annual meeting ASH 2022 Poster. Principal investigator Brian A. Jonas, M.D., Ph.D., FACP, UC Davis Division of Hematology/Oncology, leads this ongoing non-randomized, open label and multi-center study designed to evaluate the safety and efficacy of the triple combination. 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 December 2022, initial results from an investigator Phase 1b/2 study evaluating uproleselan added to cladribine plus low dose cytarabine (LDAC) in patients with treated secondary  AML (ts-AML) were presented at the ASH  annual meeting ASH 2022 Poster. The ongoing investigator-sponsored trial is led by Tapan Kadia, M.D., Associate Professor of Leukemia at The University of Texas MD Anderson Cancer Center. 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.

 

An investigator-initiated research study is being conducted at the Dana Farber Cancer Institute, Boston, MA, to see if uproleselan is safe and effective in decreasing relapse after stem cell transplant and improving leukemia-free survival in pediatric patients with acute myeloid leukemia (AML). This ongoing single arm, multi-center, Phase 1/2 trial is being led by John Horan, M.D., attending physician at Dana Farber and Associate Professor of Pediatrics, Harvard Medical School. The study involves using uproleselan as part of the pre stem cell transplant conditioning regimen in combination with high dose busulfan in pediatric patients with chemotherapy resistant AML. The study is designed to determine dosing and safety of uproleselan when combined with other drugs. In addition, the study will describe preliminary efficacy and pharmacokinetics of uproleselan as well as the severity of oral and gastrointestinal mucositis in patients receiving uproleselan.

 

Washington University in St. Louis School of Medicine 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. 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.

 

Preclinical Collaboration Partners:

The research team at GlycoMimetics has a longstanding partnership with Mater Research Institute—The University of Queensland (MRI-UQ) that provides support of translational research activities aimed at elucidating the role of E-selectin within the bone marrow microenvironment. This collaboration has 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.

 

Since 2015, GlycoMimetics has collaborated with Dr. Michael Andreeff, Professor of Medicine, Department of Leukemia, Division of Cancer Medicine, at The University of Texas MD Anderson Cancer Center, to better understand 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.