Selvita Announces U.S. FDA Acceptance of Investigational New Drug Application to Commence Clinical Development of SEL120 in the Treatment of Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
KRAKOW, Poland, March 26, 2019 /PRNewswire/ -- Selvita (WSE: SLV), a clinical stage company engaged in the research and development of novel cancer therapies as well as provision of drug discovery and development services, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 1 study of selective CDK8 inhibitor SEL120 in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS). The open-label, dose-escalation study is designed to evaluate safety and tolerability of SEL120 as well as to establish the recommended dose of SEL120 for subsequent clinical development.
"In preclinical studies, including studies with patient-derived xenografts, SEL120 has demonstrated strong promise using a novel and differentiated approach to treatment in AML," commented Steffen Heeger, M.D., Chief Medical Officer of Selvita. "This dose-finding study will help provide data in patients to potentially support the high selectivity of SEL120 for its target, a property that suggests potential for either stand alone or combination treatments. We expect to initiate dosing of the first patient with SEL120 in the third quarter of 2019. In addition, because of the recognized importance of CDK8 as a therapeutic target, we are optimistic about the potential for SEL120 to be evaluated in multiple indications beyond AML as the properties of this candidate in clinical settings become clear."
The Phase 1 study is a multicenter, dose-finding study of SEL120 in adult patients with AML or HR-MDS who are refractory to or have relapsed after previous therapy. Patients will be enrolled in the study independent of specific cancer mutation status at baseline. In preparation for study initiation, Selvita will engage with Institutional Review Boards at selected institutions in U.S. and seek to complete necessary formalities with the clinical sites.
SEL120 is an orally-available, small molecule, inhibitor of CDK8, a kinase that represents a potential therapeutic target in indications characterized by dysregulation of transcription, including hematological cancers and solid tumors. SEL120 was discovered using the Selvita discovery engine platform for identification of small molecule therapeutics with differentiated properties and has demonstrated high selectivity in preclinical studies. SEL120 has received support from the Leukemia & Lymphoma Society Therapy Acceleration Program and is in clinical development for the treatment of acute myeloid leukemia or HR-MDS as initial indications.
Selvita is developing novel small molecule therapies that address emerging targets in oncology with industry-leading research expertise supported by a research services division. Pipeline candidates apply diverse mechanisms directed at kinases, synthetic lethality pathways, immuno-oncology pathways and other cancer-related targets. SEL24/MEN1703 is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group in clinical development for the treatment of acute myeloid leukemia. SEL120 is a selective CDK8 kinase inhibitor in clinical development for the treatment of acute myeloid leukemia or HR-MDS with potential therapeutic applications in additional hematological cancers and solid tumors. Selvita is listed on the Warsaw Stock Exchange (PL: SLV) and headquartered in Krakow with offices in the U.S. and U.K.
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