GlycoMimetics to Highlight GMI-1271 Clinical Data and Underlying, Differentiated Mechanism of Action in Oral Presentations at 59th Annual ASH Meeting
- GMI-1271 improves efficacy and safety of chemotherapy in Phase 1/2 study in two acute myeloid leukemia (AML) patient populations
- Preclinical data detail underlying mechanism for GMI-1271’s ability to enhance sensitivity to chemotherapy
GlycoMimeticswill review the GMI-1271 clinical data during a briefing for investors/analysts in Boston, December 19, at 7:30 a.m. ET
The oral presentations at the ASH meeting will include results of a Phase 1/2 clinical study of GMI-1271, the company’s E-selectin antagonist, and a preclinical study demonstrating one mechanism by which E-selectin mediates resistance to chemotherapy. The clinical data will show that the drug candidate improved clinical outcomes in relapsed/refractory as well as newly diagnosed AML patients. The preclinical data point to E-selectin dependent upregulation of tumor survival pathways, which are inhibited by GMI-1271.
“The data from our Phase 1/2 clinical trial continue to show a remission
rate that is superior to historical controls as well as an excellent
safety profile, most notably meaningful reductions in severe, grade 3/4
mucositis. Data in the published abstract reflect an update as of
mid-summer, shortly after our interim report was last presented at the
Specifically, the abstract reports that among all relapsed/refractory AML patients treated at the recommended Phase 2 dose, the remission rate (CR/CRi) was 41% and overall response rate (ORR) was 50%. In the newly diagnosed AML population, the remission rate (CR/CRi) was 68% and ORR was 80%.
“These response rates are consistent with rates reported at the
For both relapsed/refractory and newly diagnosed patients treated in the Phase 2 portion of the trial, the abstract reports that median overall survival and disease-free survival had not been reached. Updated duration of remission and survival data for both populations will be presented at the ASH meeting.
“Together, the clinical and preclinical data demonstrate that GMI-1271 could represent a novel and truly differentiated approach to treatment of AML,” Dr. Thackray concluded.
Oral Presentation Details:
Abstract #894—GMI-1271 Improves Efficacy and Safety of
Chemotherapy in R/R and Newly Diagnosed Older Patients with AML: Results
of a Phase 1/2 Study. Session 616.
Abstract #793—Vascular E-Selectin Mediates Chemoresistance in
Acute Myeloid Leukemia Initiating Cells Via Canonical Receptors PSGL-1
(CD162) and AKT Signaling. Session 604.
Meeting abstracts are available on ASH’s website.
GMI-1271 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 the Phase 1/2 clinical trial which has now completed enrollment, GMI-1271 is being evaluated in both elderly and relapsed/refractory patients with acute myeloid leukemia (AML). In both populations, patients treated with GMI-1271 together with standard chemotherapy have continued to achieve higher than expected remission rates based on historical controls, as well as lower than expected induction-related mortality rates. Importantly, treatment in this patient population has been well tolerated with minimal adverse effects.
GlycoMimetics is a clinical-stage biotechnology company focused on the
discovery and development of novel glycomimetic drugs to address unmet
medical needs resulting from diseases in which carbohydrate biology
plays a key role.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements regarding the
clinical development of GMI-1271, including the expected timing of
completion of clinical trials and the presentation of clinical data.
Actual results may differ materially from those in these forward-looking
statements. For a further description of the risks associated with these
statements, as well as other risks facing