Investors are not happy with interim Phase II data presented by Syros.
Investors are not happy with interim Phase II data presented by Syros Pharmaceuticals. Share prices have fallen nearly 48 percent this morning after the company revealed its first-in-class drug candidate was only able to generate one complete responder out of 48 patients.
Despite the company’s attempt to put a positive spin on the data at the American Society of Hematology (ASH) conference over the weekend, investors bailed on the stock sending prices down to $6.42 per share. The stock closed at $12.45 on Friday.
Syros is developing SY-1425, an oral, selective retinoic acid receptor alpha (RARα) agonist, as a first-in-class treatment for patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). In its preliminary Phase II data presented at ASH, Syros presented data from two of the five cohorts in the ongoing trial. Syros said it saw “clinical activity” in 43 percent of evaluable relapsed or refractory AML and higher-risk MDS patients. The company said that included improvement in blood counts, reduction in leukemic blasts and one marrow complete response. Syros said 10 of the 23 (43 percent) evaluable relapsed or refractory AML and higher-risk MDS patients and two of the 25 (8 percent) evaluable transfusion-dependent lower-risk MDS patients had evidence of clinical activity. Syros did not elaborate on what the term clinical activity meant as far as the results. Those data points touted by the company though were not enough to please investors.
While the company had been developing SY-1425 as both a single agent treatment as well as a combination treatment, researchers suggested at ASH that the drug may be better off as a combination treatment for its disease indications.
“We saw improved blood counts and reduced blast counts in conjunction with differentiation of cancer cells in genomically defined patients. These data, along with the mechanistic and preclinical data supporting combinations with azacitidine and with daratumumab, suggest SY-1425 could be a meaningful combination agent with the potential to address a substantial unmet need for patients with AML and MDS,” Joseph G. Jurcic, director of Hematologic Malignancies Section of the Division of Hematology/Oncology at Columbia University Medical Center said in a statement.
Syros Chief Executive Officer Nancy Simonian seemed to agree. In a statement issued over the weekend, she said data released at ASH support continued development of SY-1425 in combination, which will be the company’s focus going forward.
“Our preclinical data showing the tumor-killing activity of SY-1425 in combination with azacitidine and with daratumumab support the ongoing development of SY-1425 in combination with these therapies, and we plan to present initial clinical data on these two combinations in 2018,” Simonian said in a statement.
