The goal of the SEL24 project is a development of innovative anticancer drug acting by an ability to selectively destroy cancer cells. Within the SEL24 project Selvita discovered specific, dual PIM/FLT3 inhibitors, shown to be key players in signaling pathways crucial for the development of different type of cancers – mainly acute myeloid leukemia but also other hematological malignancies.
Our best inhibitor, SEL24-B489, shows high anti-cancer efficacy in both in vitro models using cancer cell lines and in vivo including mouse models of human cancer cell lines xenografts. In our experiments we observed a synergism of our compound with established standards of care, such as cytarabine, further confirming therapeutic potential of our compound in a combinational therapy. On top of these data, SEL24-B489 shows superior activity on a panel of AML (acute myeloid leukemia) models in comparison to other selective PIM or FLT3 inhibitors currently developed by competitors.
SEL24-B489 is a bioavailable compound showing promising safety profile, supported by initial data in animal models.
In August 2016, Selvita has received an acceptance for its IND application from the U.S. Food and Drug Administration (FDA) for SEL24.
Following this FDA clearance, Selvita will now seek for an opinion of the Institutional Review Boards at selected, leading clinical hospitals in US, which were chosen to conduct the SEL 24 Phase I/II clinical trial in AML patients, as well complete necessary formalities with the clinical sites.
Selvita intends to initiate first patient dosing in Q4 2016.