Selvita and The Leukemia & Lymphoma Society Announce Partnership to Advance SEL120 Into Phase I for AML Patients

Selvita S.A. (WSE: SLV) and The Leukemia & Lymphoma Society (LLS) announced today a partnership to co-fund further preclinical and clinical development of a targeted therapy to treat patients with acute myeloid leukemia (AML). Selvita has discovered and is developing SEL120, a therapy that targets the cyclin-dependent kinase 8 (CDK8) protein, which plays a unique and critical role in gene regulation. Laboratory studies have shown the agent to be effective in certain types of AML cells.

SEL120 is an ATP-competitive and selective inhibitor of CDK8 and a closely related serine kinase, CDK19. CDK8 is a part of a multi-protein complex that regulates gene expression and is distinct from CDK4 or CDK6, which play a role in cell cycle progression. In laboratory experiments, treatment with SEL120 has been shown to result in the death of AML cells especially with elevated phosphorylation of STAT5 and stem cell characteristics, which is significant because AML stem cells are typically resistant to conventional therapies and thereby mediate relapsed disease. Moreover, the status of phosphorylation of STAT5 may provide a useful biomarker for action of the drug. The molecular mechanism of action involves modulation of various oncogenic transcriptional programs that are critical to the survival of AML cells. This unique mechanism, which does not overlap with existing therapies, may allow the development of highly effective combination therapies that may be required to provide long-term control of AML in patients.

SEL120 has shown efficacy in treating AML cells both in vitro (test tube) and in vivo (mouse models). SEL120 has successfully passed a series of non-GLP toxicity studies in mice and monkeys. Selvita initiated Investigational New Drug (IND)-enabling studies for SEL120 in June 2017, a critical step in getting the U.S. Food and Drug Administration's permission to begin in human clinical trials.

Under the terms of the agreement, LLS will provide up to $3.25 million funding over 4 years, through its Therapy Acceleration Program® (TAP), in order to help fund further SEL120 IND-enabling studies and a Phase I trial in AML.

"We are very pleased to be partnering with The Leukemia & Lymphoma Society. This partnership constitutes not only a significant validation of the high potential of SEL120 in treatment of AML patients, but also offers a unique opportunity to work with world renowned researchers, specialists in the field of hematological cancers, increasing the chances of bringing a breakthrough treatment to the patients whose treatment options currently remain very limited," said Krzysztof Brzózka, Ph.D., Chief Scientific Officer at Selvita.

"LLS has developed a comprehensive approach to beat AML, which is one of the leukemias associated with exceptionally high mortality rates. Moreover, very few effective agents are available to control AML, particularly in elderly individua