Verastem, Inc. (NASDAQ:VSTM) is a clinical-stage biopharmaceutical company focused on developing therapies to improve the lives of patients diagnosed with cancer in ways that are truly meaningful to them. Our product candidates seek to treat cancer by targeting malignant cells both directly and through modulation of the tumor microenvironment.
We are currently developing duvelisib, a dual inhibitor of phosphoinositide 3-kinase (PI3K-delta and PI3K-gamma), which has successfully met its primary endpoint in a Phase 3 registration trial in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and a Phase 2 study in refractory indolent (slow-growing) non-Hodgkin’s lymphoma (iNHL).
We have a COM (composition-of-matter) patent protection of duvelisib through 2030 before extensions, and has received orphan drug designation for duvelisib in follicular lymphoma (FL), CLL and small lymphocytic lymphoma (SLL) in the United States and the European Union. The U.S. Food and Drug Administration (FDA) has granted fast track designation to the investigation of duvelisib for the potential treatment of patients with CLL who have received at least one prior therapy, of patients with FL who have received at least two prior therapies and of patients with peripheral T-cell lymphoma (PTCL) who have received at least one prior therapy.
In April 2018, the FDA accepted with Priority Review our New Drug Application (NDA) for duvelisib.
Other clinical product candidates include focal adhesion kinase (FAK) inhibitor defactinib. Defactinib is currently being evaluated in three separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types, including pancreatic, ovarian and non-small cell lung cancer (NSCLC), and mesothelioma.