Krakow, Poland, April 18, 2016 / B3C newswire / -- Selvita (WSE:SLV), the largest drug discovery company in Central and Eastern Europe, has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for SEL24, the first compound to advance in clinical development from the company’s internal discovery pipeline.
SEL24 is a novel, orally-available small molecule, the first potent, dual inhibitor of PIM and FLT3 kinases. It is the first molecule with this mechanism of action, to progress to such stage of development.
SEL24 shows therapeutic potential in the treatment of acute myeloid leukemia (AML), as well as other hematological malignancies such as non-Hodgkin’s lymphoma, Hodgkin’s lymphoma and multiple myeloma. Moreover, SEL24 increases the effectiveness of other anticancer agents in animal models. Pending FDA clearance, Selvita intends to initiate a Phase I clinical trial in Q3 2016.
“Filing the IND is a major milestone in the development of SEL24 and Selvita. It may also lead to a new investigational therapeutic option for the AML patients, their families and their caregivers, as we advance SEL24 towards human clinical trials” - said Dr. Krzysztof Brzozka, Chief Scientific Officer of Selvita.
“In preclinical studies, SEL24 has demonstrated encouraging anti-tumor activity in AML, illness for which new treatment options are urgently needed. We look forward to further investigating these findings in the clinical setting which will be initiated at some of the best clinical hospitals in the world.” - added Ireneusz Otulski MD, Head of Clinical Operations at Selvita
PIM and FLT3 protein kinases are over-expressed in multiple hematological cancers and certain solid tumors. SEL24 demonstrates strong cytotoxic effects in AML cell lines, independently of the FLT3 mutation status, in contrast to available target-selective kinase inhibitors. In preclinical studies, SEL24 has shown significant anticancer effects in multiple hematological xenograft models as a single agent, and has demonstrated synergistic effects with marketed standard of care compounds as well as therapies in advanced clinical development, such as cytarabine, without an associated increase in systemic toxicity.
Selvita Oncology Pipeline
In its internal research and development efforts, Selvita focuses on oncology. The company’s most advanced R&D program is SEL24, a dual PIM/FLT3 kinase inhibitor currently in IND-enabling studies for hematopoietic tumors, intended to enter the clinic in Q3 2016. The second most advanced program is SEL120, a first-in-class small molecule inhibitor of CDK8 with potential use in hematological malignancies, colorectal cancer and breast cancer. Other key R&D programs include SEL201 focused on MNK1 / MNK2 kinases and therapeutic indication in combination therapies of solid tumors. Selvita Early Discovery programs include: SEL212 - a NALP3 inflammasome modulators for the treatment of autoinflammatory and autoimmune disorders, Immunooncology platform - small molecule GCN2 inhibitors and STING agonists. Eptheron - an oncology platform with an aim to develop novel molecules specifically targeting certain epigenetic and metabolic abnormalities in cancer. In addition to that, Selvita has an early discovery stage programs targeting 1-C metabolism and heme oxygenase.
About Selvita
Selvita is a drug discovery company engaged in the research and development of breakthrough therapies in the area of oncology, as well as provision of integrated drug discovery services. Selvita offices are located in Greater Boston Area, San Francisco Bay Area, Cambridge, UK, as well as in Krakow, Poland. Selvita was established in 2007 and currently employs 330 people, including 104 PhDs, with extensive experience in the area of life sciences. Selvita has currently several projects at early or late discovery stage and is expected to move its first candidates to the clinic in 2016. Drug discovery clients of Selvita include more than fifty large and medium-sized pharmaceutical and biotechnology companies from USA and Europe. The company is listed on the Warsaw Stock Exchange (WSE:SLV).
