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

KRAKOW, Poland and RYE BROOK, New York, August 8, 2017 /PRNewswire/ --

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 individuals where the disease commonly occurs," said Lee Greenberger, Ph.D., LLS's Chief Scientific Officer. "LLS is focused on identifying and advancing the most innovative therapeutics to control and/or eradicate blood cancers. LLS's partnership with Selvita understates our commitment to accelerating cures for this deadly disease."

LLS's Therapy Acceleration Program® (TAP) funds innovative projects related to therapies, supportive care or diagnostics that have the potential to change the standard of care for patients with blood cancer, especially in areas of high unmet medical need. Further development of the SEL120 project will be co-funded through the Biotechnology Accelerator Division, a strategic initiative to partner directly with biotechnology companies.

About The Leukemia & Lymphoma Society 

The Leukemia & Lymphoma Society ® (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world and provides free information and support services.

Founded in 1949 and headquartered in Rye Brook, New York, LLS has chapters throughout the United States and Canada. Since 1953, LLS has funded over $1 B in blood cancer research through 4000 grants to academic institutions and over 50 therapeutic opportunities through the TAP program. For more information please visit: http://LLS.org/

About Selvita S.A. 

Selvita S.A. is a drug discovery company, developing breakthrough therapies in the area of oncology. The company's most advanced program, SEL24, has been licensed to Menarini Group and is currently in Phase I studies in AML. Other projects include SEL120, a first-in-class small molecule inhibitor of CDK8 in preclinical studies, several drug discovery platforms in immuno-oncology, immunometabolism and cancer metabolism, as well as epigenetics, performed independently or in collaboration with global pharma and biotech companies.

Selvita also offers a wide range of integrated drug discovery services, helping biotech and pharma partners discover and develop new drugs.

The company has alliances and partnerships with more than fifty large and medium-sized pharmaceutical and biotechnology companies from USA and Europe, including R&D partnerships with Merck, H3 Biomedicine, Nodthera Therapeutics/Epidarex Capital and Menarini Group.

The company was established in 2007 and currently employs over 400 scientists, among which 30% are PhDs. Selvita is headquartered in Krakow with second research site in Poznan, Poland and international offices located in Cambridge, MA and San Francisco Bay Area, in the US, as well as in Cambridge, UK. Selvita is listed on the Warsaw Stock Exchange (WSE: SLV). More information: http://selvita.com/

SOURCE Selvita S.A.