Selvita doses first acute myleoid leukemia patient testing CDK8 inhibitor

Selvita has dosed the first patient in its Phase 1b study of CDK8 inhibitor, SEL120, which is being initially investigated in the treatment of patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS).

Selvita further said that this open-label, dose-escalation study is being conducted at multiple sites in the U.S. and evaluates the safety, tolerability and the preliminary activity of SEL120, as well as establishing a recommended dose for further clinical development.

Dr. Setareh Shamsili, Chief Medical Officer of Selvita, said: “CDK8 represents an important potential therapeutic target in cancer. SEL120, an orally available small molecule, is potentially the best in class CDK8 inhibitor and is the first in class to enter the clinical trials.”

Dr. Shamsili said that SEL120 has been identified through the company’s in-house discovery platform with having differentiating characteristics, such as high selectivity, and has potential for development in a broad range of both hematological and solid malignancies. “In preclinical studies, SEL120 has shown strong proof of concept for the treatment of AML, a disease where patients still face poor prognosis,” said Shamsili, noting that the company expects to share the preliminary results of SEL120 study with the oncology community in 2020.

This Phase 1b study is a multicenter, sequential, modified 3+3 dose escalation study in adult patients with AML or HR-MDS who are refractory to treatment or have relapsed after previous therapies, Selvita said.