GlycoMimetics Inc (NASDAQ:GLYC) just announced that new data on uproleselan-treated high risk patients with both relapsed/refractory and newly diagnosed AML were presented at an oral session during the 60th American Society of Hematology (ASH) Annual Meeting and Exposition.
According to the release, an analysis of clinical outcomes from the Phase 1/2 clinical study showed that uproleselan (GMI-1271) resulted in the majority of evaluable patients achieving a stringent level of measurable residual disease (MRD) negativity, an effect which translated into extended overall survival relative to matched, historical controls.
GlycoMimetics Inc (NASDAQ:GLYC) bills itself as a clinical stage biotechnology company that focuses on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in the United States.
Its advanced drug candidate, rivipansel, is a pan-selectin antagonist, which is developed for the treatment of vaso-occlusive crisis in sickle cell disease and has evaluated in a Phase 3 clinical trial, conducted by its strategic collaboration with Pfizer Inc.
The company’s drug candidate, GMI-1271, an E-selectin antagonist, is evaluated in a Phase 1/2 clinical trial as a potential treatment for acute myeloid leukemia and is in a Phase 1 clinical trial for the treatment of multiple myeloma. It is also developing a Phase 1 clinical trial drug candidate, GMI-1359, a combined CXCR4 and E-selectin antagonist.
Uproleselan (yoo’ pro le’sel an) is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed/refractory patients with AML.
In both populations, patients treated with uproleselan together with standard chemotherapy achieved better than expected remission rates and overall survival, as well as lower than expected induction-related mortality rates, as compared to historical controls which have been derived from results from third party clinical trials evaluating standard chemotherapy.
The U.S. Food and Drug Administration (FDA) has granted uproleselan Breakthrough Therapy Designation for the treatment of adult AML patients with relapsed/refractory (R/R) disease. GlycoMimetics is currently implementing a comprehensive development program across the clinical spectrum of AML. This includes a company sponsored Phase 3 trial in R/R AML and two consortia-sponsored trials in newly diagnosed patients. One consortium trial is being sponsored by the NCI and will enroll newly diagnosed patients fit for intensive chemotherapy. The other trial is sponsored by the HOVON group in Europe and will enroll newly diagnosed patients unfit for intensive chemotherapy.
As we discussed earlier, GLYC just announced that new data on uproleselan-treated high risk patients with both relapsed/refractory and newly diagnosed AML were presented at an oral session during the 60th American Society of Hematology (ASH) Annual Meeting and Exposition.
The announcement helped to spark a relief rally in a context of recent action that hasn’t been particularly fun for GLYC shareholders. Over the past week, shares of the stock have suffered from clear selling pressure, dropping by roughly -2% even with the push higher on the news. Over the past month, shares of the stock have suffered from clear selling pressure, dropping by roughly -19%.
“The new MRD and correlative efficacy data in difficult-to-treat patients, when combined with the already encouraging response rate and survival results from this trial, further demonstrate the potential of uproleselan to be an important new treatment option in AML,” said Daniel J. DeAngelo, M.D., Ph.D., Chief of the Division of Leukemia at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital, and the trial’s lead investigator. “The fact that more than half of the evaluable patients achieved a stringent level of MRD negativity is particularly noteworthy as uproleselan’s mechanism of action is to selectively disrupt the relationship between leukemic cells and the bone marrow microenvironment.”
GlycoMimetics Inc (NASDAQ:GLYC) had no reported sales in its last quarterly financial data. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($219.8M against $6.4M).