TG Therapeutics, BCRP Partner For Ibrutinib Combo Clinical Trial
By Cyndi Root
TG Therapeutics has partnered with the Blood Cancer Research Partnership (BCRP) and the Dana-Farber Cancer Institute (DFCI), the lead institute of the BCRP, to study a combination of TGR-1202 and ibrutinib in B-cell malignancies. The company announced the initiation of the Phase 1 trial in a press release, stating that the Leukemia & Lymphoma Society (LLS) is also providing support.
Matthew S. Davids, MD, the study Chair, said, "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.”
Ibrutinib
Ibrutinib is a kinase inhibitor that blocks abnormal proteins implicated in cancer cell proliferation. The oral agent was first approved by the Food and Drug Administration (FDA) in November 2013 to treat patients with mantle cell lymphoma (MCL). In February 2014, the FDA expanded the approval to chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy, and in June 2014, the agency made it applicable to CLL patients who carry a deletion in chromosome 17 (17p deletion).
TGR-1202
TGR-1202 is a PI3K delta inhibitor and an oral agent like ibrutinib. Michael S. Weiss, Executive Chairman and Interim CEO of TG Therapeutics, states that TGR-1202’s safety profile, especially in liver toxicity, makes it well suited as a combination therapy. Formerly known as RP5264, TGR-1202 targets the delta isoform, which is strongly expressed in B-cell lymphocytes.
Ibrutinib and TGR-1202 Trial
The multi-center, Phase 1 trial is titled, “A Multi-center Phase 1/1b 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.” The Dana Farber institute is the lead center in the trial that will enroll patients with CLL or MCL who have not responded to standard treatment. Investigators expect to collect data for the primary outcome measure by 2018.
About TG Therapeutics
TG Therapeutics is headquartered in New York City where it focuses on treatments for cancer and autoimmune diseases. In October, the company exercised its option to license TGR-1202 from Rhizen Pharmaceuticals due to the success of the joint development venture. In June, the company licensed Ligand's IRAK4 inhibitor research program, currently in pre-clinical development.