TG Therapeutics, Inc. Announces Investigator Initiated Trial at the University of Nebraska Medical Center to Study TGR-1202 in Combination with Ibrutinib in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma
January 04, 2017 at 07:30 am EST
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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.
TG Therapeutics, Inc. is a fully integrated, commercial stage, biopharmaceutical company. The Company is focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. Its clinical drug candidates include Ublituximab (anti-CD20 mAb), TG-1701 (BTK inhibitor) and TG-1801 (anti-CD47/CD19 bispecific mAb). BRIUMVI is an anti-CD20 monoclonal antibody for the treatment of RMS, which include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. TG-1701 is a novel, orally available and covalently bound Brutonâs tyrosine kinase (BTK) inhibitor that exhibits selectivity to BTK in in vitro kinase screening. TG-1801 is a bispecific CD47 and CD19 antibody. It is the therapy to target both CD19, a B-cell specific market expressed across B-cell malignancies, and CD47. It also evaluates complementary products, technologies and companies for in-licensing, partnership, acquisition and/or investment opportunities.
TG Therapeutics, Inc. Announces Investigator Initiated Trial at the University of Nebraska Medical Center to Study TGR-1202 in Combination with Ibrutinib in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma