TG Therapeutics, Inc. announced the opening of an investigator initiated Phase 2 study at the University of Nebraska Medical Center (UNMC) to evaluate the safety and efficacy of TGR-1202, the Company's oral PI3K delta inhibitor in combination with ibrutinib, in patients with relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL). TG Therapeutics and Janssen Pharmaceuticals will each provide drug and equally share study-related costs. The rationale for combining these two agents is based on the prior clinical activity and tolerable safety profile observed with TGR-1202 both alone and in combination with ibrutinib in previous studies, as well as preclinical work conducted as part of a research collaboration with Dr. Michael Green and the University of Nebraska Medical Center’s Lymphoma Precision Medicine Laboratory in Omaha, NE. The combination of TGR-1202 and ibrutinib has been studied previously in patients with Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin’s lymphoma, both with and without the addition of the anti-CD20 monoclonal antibody TG-1101 (ublituximab). Data on the combination of TGR-1202 plus ibrutinib were presented most recently at the 2016 American Society of Hematology (ASH) meeting, with data demonstrating an acceptable safety profile at full doses of both ibrutinib and TGR-1202. The Phase 2 study will evaluate the safety and efficacy of the combination of TGR-1202 and ibrutinib, as well as explore correlative analyses related to the combination.