GlycoMimetics Stock Takes Off on Positive Phase II Leukemia Data, Breakthrough Tag

May 18, 2017
By Mark Terry, BioSpace.com Breaking News Staff

Rockville, Mary.-based GlycoMimetics ’ jumped dramatically on the news of positive interim Phase II data for GMI-1271 for acute myeloid leukemia.

The company announced that it is presenting data at the June annual meetings of the American Society of Clinical Oncology (ASCO) and the European Hematology Association (EHA). The highlights of the published abstract note that 47 patients were enrolled in the trial, with 30- and 60-day mortality at 0 and 7 percent, respectively, and the median overall survival in the Phase I part of the trial was 7.6 months.

GMI-1271 is an E-selectin antagonist. In combination with chemotherapy, patients with AML had higher-than-expected remission rates and lower-than-expected induction-related mortality rates.

“The data has consistently shown good tolerability and high remission rates as well as lower than expected 30- and 60-day mortality rates in early evaluations of patients,” said Helen Thackray, GlycoMimetics’ chief medical officer, in a statement. “We are increasingly confident that our investigational drug, GMI-1271, may play a role in addressing unmet needs in this cancer. It is particularly noteworthy to see in the relapsed/refractory cohort that patients who have higher levels of the E-selectin ligand biomarker on their leukemic blasts appear to be more likely to achieve remission of their disease. This observation builds directly on what we and others have reported in the preclinical and clinical settings about the key role E-selectin plays in many forms of cancer, including AML. Importantly, this provides what we believe is the first direct clinical evidence of the potential benefit of targeting of E-selectin in this difficult-to-treat population of AML patients.”

The U.S. Food and Drug Administration (FDA) has given the drug Breakthrough Drug status, as well as orphan and fast-track designations.

“The FDA’s granting to GMI-1271 of Breakthrough Therapy designation will further help GlycoMimetics to accelerate the development of GMI-1271 as a treatment for this very difficult-to-treat patient population,” Thackray said in a statement. “We believe GMI-1271 when combined with chemotherapy has the potential to address an unmet therapeutic need for individuals living with AML.”

The study has two groups of AML patients. Patients who are resistant to treatment and patients that are newly diagnosed and are over the age of 60. John Carroll, writing for Endpoints News, says, “The drug is designed to target pathways tumors use to defend against therapies, heightening the effect of chemo. Last December investigators noted that for 33 study participants with relapsed or refractory disease in one arm of the trial, the complete response rate was 45 percent. For 11 newly diagnosed study participants 60 or more years of age in the second arm of the trial, the CR rate was 73 percent.”

As noted earlier, shares rose on the news from $3.89 on May 8 to a current trading price of $7.49. Its yearly high was $8.97 on June 3, 2016.

The abstracts to be presented at ASCO, which will be held June 2 to 5 in Chicago, are #2520 (“GMI-1271, a Novel E-Selectin Antagonist, in Combination with Chemotherapy in Relapsed/Refractory AML”) and #2560 (“GMI-1271, a Novel E-Selectin Antagonist, Combined with Induction Chemotherapy in Elderly Patients with Untreated AML.”)

The abstracts to be presented at EHA, which will be held in Madrid, Spain from June 22 to 25, are, P547 (“GMI-1271, A Potent E-Selectin Antagonist, In combination With Chemotherapy In Relapsed/Refractory AML: A Novel, Well-Tolerated Regimen With A High Remission Rate”) and P203 (“GMI-1271, A Potent E-Selectin Antagonist, Combined With Induction Chemotherapy in Elderly Patients with Untreated AML: A Novel, Well-Tolerated Regimen With A High Remission Rate.”)