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GlycoMimetics Announces New Uproleselan Clinical Data in Both Frontline Unfit and Treated Secondary Acute Myeloid Leukemia Will Be Presented at ASH Annual Meeting
GlycoMimetics, Inc. (NASDAQ: GLYC) announced acceptance of data from two investigator-sponsored trials studying uproleselan in acute myeloid leukemia (AML) for presentation at the 64th American Society of Hematology Annual Meeting. Uproleselan is a targeted E-selectin inhibitor currently in Phase 3 development. Initial results emphasize its safety and preliminary efficacy for both frontline unfit and treated secondary AML patients. This marks the first clinical data outside company-sponsored studies, potentially enhancing treatment options for heterogeneous AML populations.
Positive
Initial results from two trials of uproleselan show safety and preliminary efficacy in AML.
Uproleselan is in a comprehensive Phase 3 development program and has received Breakthrough Therapy Designation from the FDA.
Negative
None.
ROCKVILLE, Md.--(BUSINESS WIRE)--
GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today announced that data from two investigator-sponsored trials studying uproleselan in patients with acute myeloid leukemia (AML) have been accepted for poster presentation at the 64thAmerican Society of Hematology (ASH) Annual Meeting.
“We are excited to share initial results from these two investigator-sponsored trials of uproleselan regarding safety and preliminary efficacy in frontline unfit and treated secondary AML populations not previously studied with this novel investigational agent,” said Edwin Rock, M.D., Ph.D., Chief Medical Officer. “These presentations provide the first uproleselan clinical data generated outside of company-sponsored studies. We thank these investigators and patients for their efforts and consent, respectively, to help us learn how adding uproleselan to existing therapies may benefit people with heterogeneous forms of AML.”
Details on GlycoMimetics posters at the ASH Meeting are as follows (all times CT):
Publication Number: 1448
Title:Uproleselan Added to Cladribine Plus Low Dose Cytarabine (LDAC) in Patients with Treated Secondary Acute Myeloid Leukemia (TS-AML)
Authors: Emmanuel Almanza-Huante, Hagop Kantarjian, Kelly Chien, Courtney Dinardo, Nicholas Short, Abhishek Maiti, Guillermo Montalban-Bravo, Naval Daver, Jitesh Kawedia, Kayleigh Bowie, Sherry Pierce, Farhad Ravandi, Marina Konopleva, Guillermo Garcia-Manero, Tapan M. Kadia Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster I
Session Date/ Presentation Time:Saturday, December 10, 2022, 5:30 PM - 7:30 PM Location:Ernest N. Morial Convention Center, Hall D
Publication Number: 2764
Title:A Phase I Study of Uproleselan Combined with Azacitidine and Venetoclax for the Treatment of Older or Unfit Patients with Treatment Naïve Acute Myeloid Leukemia
Authors: Brian A Jonas, Jeanna L Welborn, Naseem S Esteghamat, Rasmus T Hoeg, Aaron S Rosenberg, Laura Molnar, Ashley Linh Dang-Chu, Susan L Stewart, Joseph M Tuscano
Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II
Session Date/Presentation Time:Sunday, December 11, 2022, 6:00 PM - 8:00 PM Location:Ernest N. Morial Convention Center, Hall D
About Uproleselan
Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’se lan), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration and from the Chinese National Medical Products Administration for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan 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.
About GlycoMimetics, Inc.
GlycoMimetics is a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including acute myeloid leukemia (AML), and for inflammatory diseases with high unmet need. The Company’s science is based on understanding the role that carbohydrates play on the surface of every living cell and applying specialized chemistry to discover small molecule drugs, known as glycomimetics, that alter these carbohydrate-mediated pathways in diverse disease states, including cancer and inflammation. As a leader in this space, GlycoMimetics is leveraging this unique targeted approach to advance its pipeline of wholly-owned drug candidates, with the goal of developing transformative therapies for serious diseases. GlycoMimetics is in Rockville, MD in the BioHealth Capital Region. Learn more at www.glycomimetics.com.
Forward-Looking Statements
To the extent that statements contained herein are not descriptions of historical facts, they are forward-looking statements reflecting the current beliefs and expectations of the management of GlycoMimetics, Inc. (“GlycoMimetics,” “we,” “us,” or “our”). Forward-looking statements include, but are not limited to, the expected presentation of clinical data for uproleselan as well as its potential benefit and impact, and any other statement containing terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “intends,” or “continue,” or the negative of these terms or other comparable terminology. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be materially different from those discussed, implied or otherwise anticipated by such statements. You are cautioned not to place undue reliance on such forward-looking statements, which are current only as of the date of this presentation. For a further description of the risks associated with forward-looking statements, as well as other risks facing GlycoMimetics, please see the risk factors described in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 3, 2022, as well as other reports we file with the U.S. Securities and Exchange Commission from time to time, including those factors discussed under the caption “Risk Factors” in such filings. Forward-looking statements speak only as of the date of this presentation, and GlycoMimetics undertakes no obligation to update or revise these statements, except as may be required by law.
What is uproleselan's indication in the ongoing trials?
Uproleselan is being studied for its safety and efficacy in treating acute myeloid leukemia (AML), particularly in unfit and treated secondary AML patients.
When will the trial data for uproleselan be presented?
The trial data will be presented at the 64th American Society of Hematology Annual Meeting on December 10-11, 2022.
What is GlycoMimetics' stock symbol?
GlycoMimetics' stock symbol is GLYC, traded on NASDAQ.
What is the significance of Breakthrough Therapy Designation for uproleselan?
Breakthrough Therapy Designation from the FDA signifies that uproleselan may offer significant improvements over existing therapies for AML, facilitating its development and review process.
