TG Therapeutics Announces Collaboration For A Clinical Trial Of TGR-1202 In Combination With Ibrutinib For Patients With Select B-Cell Malignancies

TG Therapeutics, Inc.

announced today the initiation of a multi-center, Phase I trial to evaluate the safety and efficacy of the combination of TGR-1202 and ibrutinib for patients with relapsed and/or refractory chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). This is the first clinical trial evaluating the "all oral" combination of TGR-1202, the company's novel, once per day, PI3K Delta inhibitor with ibrutinib, the oral Bruton's tyrosine kinase (BTK) inhibitor approved by the U.S. Food and Drug Administration (FDA). The study is being run in collaboration with the Blood Cancer Research Partnership and Dana-Farber Cancer Institute (DFCI), Boston, MA. The trial, entitled "A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of the Novel PI3k Delta Inhibitor TGR-1202 in Combination with Ibrutinib in Patients with Select B-Cell Malignancies" is enrolling patients with CLL and MCL whose disease is relapsed from or refractory to prior therapy, including prior PI3K Delta inhibitors, and/or BTK inhibitors. DFCI is the lead center for the trial, with Matthew S. Davids, MD, MMSc as the Study Chair. The trial is being supported in part by the Blood Cancer Research Partnership (BCRP), a network of sites for clinical trial testing of innovative blood cancer therapies, established by The Leukemia & Lymphoma Society (LLS) and DFCI. More information on the Blood Cancer Research Partnership can be found at http://www.dana-farber.org/Research/Departments-and-Centers/Blood-Cancer-Research-Partnership.aspx. Michael S. Weiss, Executive Chairman and Interim Chief Executive Officer of TG Therapeutics, stated, "TGR-1202 has continued to demonstrate a unique safety profile, particularly as it relates to liver toxicity, as compared to other PI3K delta inhibitors that we believe makes it well suited for combination therapy. We are excited to launch the first, novel "all oral" and once-daily combination of our PI3K delta inhibitor, TGR-1202, with ibrutinib. We greatly appreciate the support and interest from the BCRP, the LLS as well as the team from Dana-Farber, and look forward to a strong collaboration." Dr. Matthew Davids added "In the past year, we have witnessed the approval of targeted oral agents such as ibrutinib that are well-tolerated and highly efficacious in CLL and other B cell malignancies. This therapeutic revolution has only just begun, and the critical next step will be to evaluate rational combinations of new oral agents to determine the safety and efficacy of combination therapy. We are excited by the opportunity to evaluate the combination of one of the most promising novel agents in development, TGR-1202, with ibrutinib in CLL and MCL." Additional details of the Phase I trial are available on www.clinicaltrials.gov, Identifier: NCT02268851.