Selvita Announces First Patient Dosed in Phase 1b Study of CDK8 Inhibitor SEL120 in the Treatment of Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

KRAKOW, Poland, Sept. 6, 2019 /PRNewswire/ -- 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.

About SEL120

SEL120 is an oral, selective inhibitor of CDK8, a kinase which is a part of the mediator complex and is essential for the activity of super-enhancers important to the regulation of RNA transcription. CDK8 kinase is implicated in the development of hematological malignancies and solid tumors. SEL120 was discovered with the Selvita discovery engine platform and is currently in clinical development for the treatment of acute myeloid leukemia and high risk myelodysplastic syndrome. SEL120 has received support from The Leukemia & Lymphoma Society Therapy Acceleration Program® (TAP), a strategic initiative to partner directly with innovative biotechnology companies and leading research institutions to accelerate the development of promising new therapies for blood cancers. More information about TAP program is available at: https://www.lls.org/therapy-acceleration-program

About Selvita

Selvita is developing novel small molecule therapies that address emerging targets in oncology and provides industry-leading research services. Pipeline candidates make use of diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules directed at kinase, synthetic lethality, immuno-oncology and cancer metabolism targets. SEL120 is a selective CDK8 kinase inhibitor with potential for development in hematological malignancies and in solid tumors, currently in clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndrome. SEL24/MEN1703 is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group in Phase 1/2 clinical development for the treatment of acute myeloid leukemia. Selvita is headquartered in Krakow with offices in the U.S. and U.K. Ardigen, a provider of precision medicine and artificial intelligence services, and NodThera, a company developing a new class of medicines to treat chronic inflammation, were conceived, incubated and launched by Selvita. In March 2019, Selvita announced the intent to split its oncology development and research services divisions into separate companies.

Forward-Looking Statements

This release may contain forward-looking statements, including, among other things, statements regarding the guidance from management, timing and/or results of clinical studies. Selvita cautions the reader that forward-looking statements are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial conditions, performance or achievements of Selvita, or industry results, to be materially different from any historic or future results, conditions, performance or achievements expressed or implied by such forward-looking statements. In addition, even if Selvita's results, performance, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that Selvita's expectations regarding development programs may be incorrect, the inherent uncertainties associated with competitive developments, clinical study and projects development activities and regulatory approval requirements, Selvita's reliance on collaborations with third parties, and estimating the commercial potential of its development programs. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Selvita expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

SOURCE Selvita