On December 10, 2023 GlycoMimetics, Inc. (Nasdaq: GLYC), a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, reported that the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting will feature two presentations on uproleselan, including an investigator-initiated trial (IIT) studying the first-in-class E-selectin antagonist in patients with treated secondary Acute Myeloid Leukemia (ts-AML) (Press release, GlycoMimetics, DEC 10, 2023, View Source [SID1234638370]).

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"We are excited by the results from this IIT demonstrating the safety and preliminary efficacy of uproleselan in ts-AML patients, a group with few treatment options and persistent high unmet need," said Edwin Rock, M.D., Ph.D., Chief Medical Officer of GlycoMimetics. "These findings underscore the broad potential of uproleselan, if successfully developed in combination with existing therapies, to benefit people with heterogeneous forms of AML. We are committed to exploring this potential across different age groups and disease settings through studies conducted by partners and independent investigators, and we thank them for their continued collaboration."

Uproleselan Added to Cladribine Plus Low Dose Cytarabine (LDAC) in Patients with Treated Secondary Acute Myeloid Leukemia (TS-AML)

Presenter: Emmanuel Almanza Huante, M.D., Department of Leukemia
The University of Texas MD Anderson Cancer Center, Houston, TX
Session: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II
Time and Location: Sunday, December 10, 2023: 6:00 PM-8:00 PM PST, Halls G-H, San Diego Convention Center
Poster Number: 2922

This Phase 1b/2 clinical trial evaluated safety, tolerability, and preliminary efficacy of uproleselan added to cladribine and LDAC in patients with ts-AML.
This rare, high-risk study population is defined by prior chemotherapy treatment of a previous hematologic disorder, such as myelodysplastic syndrome. Median survival of ts-AML patients is less than 5 months.
A majority of the 20 patients enrolled in this IIT were male (n=14), and median age of enrolled patients was 72 years. All patients had unfavorable cytogenetics and had previously received treatment with a hypomethylating agent. Also, 11 patients (55%) had received prior treatment with venetoclax, and five (25%) had undergone stem cell transplantation.
At a median follow-up of 8.1 months, results from 18 evaluable patients showed that cladribine and LDAC combined with uproleselan generated few treatment-related adverse events. The combination produced an overall response in 7 (39%) patients and reduced bone marrow blasts (morphologic leukemia-free state) in 13 (72%) patients. Median overall survival was 5.3 months.
Disease responses were seen irrespective of previous hypomethylating agent and venetoclax exposure. Three patients went on to receive a potentially curative hematopoietic cell transplantation (HCT). Study investigators concluded these data support this low-risk approach to marrow blast reduction and disease control in preparation for HCT.
Pediatric Acute Leukemia (PedAL) Screening Trial – Developing New Therapies for Relapsed Leukemias (APAL2020SC)

Presenter: Michele S. Redell, MD, Texas Children’s Cancer Center, Baylor College of Medicine, Houston
Session: 613. Acute Myeloid Leukemias: Clinical and Epidemiological: Poster I
Time and Location: Saturday, December 9, 2023, 5:30 PM-7:30 PM PST, Halls G-H, San Diego Convention Center
Poster Number: 1492

This poster reports progress to date of the PedAL Initiative, a screening trial (APAL2020SC/NCT0472624) sponsored by the Leukemia & Lymphoma Society in North America, Australia and New Zealand. Primary aims of PedAL are (1) to use clinical and biological characteristics to screen for eligibility for therapeutic sub-trials; and (2) to maintain a longitudinal data registry and biobank for relapsed leukemia. As a screening protocol, PedAL serves as the entry point for associated therapeutic sub-trials.
One participating sub-trial is a National Cancer Institute sponsored Phase 1 dose escalation study (APAL2020E/PEPN2113), which assesses safety and preliminary activity of uproleselan plus fludarabine and high dose cytarabine in pediatric AML patients after 2 or more prior therapies. Expected enrollment of 18 patients has begun with the first patient receiving study therapy in late 2023.
About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class E-selectin antagonist. Uproleselan (yoo’ pro le’se lan), currently in a broad development program including a late-stage Phase 3 trial in acute myeloid leukemia (AML), has received Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration and Breakthrough Therapy designation 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 binding and stimulation of myeloid cells. E-selectin is expressed on the surface of blood vessels, and its binding to myeloid cells confers a pro-survival effect via NF-kB signaling. Uproleselan is being developed to provide a novel approach to disrupting established mechanisms of leukemic cell resistance.