After updating industry watchers on the progress for a key cancer drug in development, shares of GlycoMimetics (NASDAQ:GLYC) are falling 13.4% as of 12:30 p.m. EDT today.
At the American Society of Clinical Oncology (ASCO) annual meeting this week, GlycoMimetics is updating stakeholders on phase 1/2 results for GMI-1271, a drug for use alongside chemotherapy in the treatment of relapsed or refractory acute myeloid leukemia (AML).
The company reports that the overall response rate in 54 evaluable AML patients was 41%, and median overall survival from the phase 1 portion of the study was 7.6 months. In 25 newly diagnosed AML patients over age 60, the overall response rate was 68%. According to management, the data is better than historical controls.
However, the data appears to be a bit weaker than what some might have been looking for. Previously, management said the overall response rate in 42 evaluable patients was 50%, so the declining ORR as more patients become evaluable could be weighing down optimism.
Today's news comes after shares marched significantly higher last month after management announced that GMI-1271 had received FDA breakthrough designation, which expedites the development and review of drugs.
Given the share-price run-up, it's not too surprising that shares are giving back some gains today. The data suggest that GlycoMimetics may be onto something with GM-1271, but investors will need to see more mature data from this trial, and possibly from a confirmatory trial, before knowing for sure what the commercial opportunity for it could be. Overall, it's common for clinical trials to fail, even in the later stages of development, so investors are right to approach this data with a healthy dose of skepticism.