Selvita (WSE: SLV) today announced that the first patient enrolled in the Phase 1b study of company’s selective CDK8 inhibitor, SEL120, has received the first dose. SEL120 is being initially investigated in the treatment of patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS). 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.
“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,” commented Dr. Setareh Shamsili, Chief Medical Officer of Selvita.
“SEL120 has been identified through our 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. We’re very grateful for the strategic support and advisory role that The Leukemia & Lymphoma Society (LLS) has played in bringing SEL120 into clinical development through its Therapy Acceleration Program® (TAP). We expect 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. Patients will be enrolled in the study independent of specific tumor mutational burden. The study will also assess pharmacokinetic and pharmacodynamic parameters of SEL120. Selvita is the sole sponsor of the Study.