Syros sees strategic shift after the failure of the previously promising cancer drug – asume tech

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A biotech company developing drugs to treat cancer by controlling gene expression is shifting its focus to the failure of a drug that has been tested in patients with solid tumors.

Syros of Cambridge, Massachusetts, said Thursday that data from the extension of his phase I trial of SY-1365, an intravenous CDK7 inhibitor, did not show that a patient had achieved an objective response to treatment. The best response was a stable disease in 13 out of 31 patients whose efficacy could be assessed, meaning that their tumors did not continue to grow, but did not contract. The study enrolled patients with breast cancer, ovarian cancer and advanced solid tumors enrolled in single drug and combination cohorts.

The shares of Syros gave after the news against the Nasdaq by 32.3 percent.

The company has therefore decided to shift its focus from SY-1365 to another drug, the oral CDK7 inhibitor SY-5609, which more selectively and effectively inhibits CDK7 than SY-1365, and has shown stronger antitumor activity in preclinical tests. The Company plans to discontinue the development of SY-1365 and initiate a Phase I trial of SY-5609 in the first quarter of 2020.

Patients in the single drug expansion cohorts received SY-1365 initially twice weekly at 80 mg per square meter of body area, while patients in the combination cohorts received it once weekly at 53 mg per square meter. Adverse reactions believed to be related to intravenous administration including headache, nausea and vomiting prompted the company to investigate extended cohort infusion times and lower doses in the single-agent cohorts.

However, Syros believes that more frequent dosing or a higher dose, which would prolong the infusion time to improve the tolerability of the drug, would be needed to maintain the CDK7 targeting required for sufficient clinical activity both would be the case to a dosing schedule that is overly stressful for patients. SY-5609 can solve this dilemma better, the company said.

The lack of objective answers in the study suggests that dose reductions and longer infusion times could affect efficacy, Cowen analyst Phil Nadeau said in a statement to investors on Thursday. The news was disappointing as the preclinical data and Phase I dose-response data suggested that SY-1365 would be more effective and safer.

Photo: Jane1, Getty Images

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Syros sees strategic shift after the failure of the previously promising cancer drug - asume tech

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