TG Therapeutics, Inc. announced Wednesday the start of a Phase 1/2 clinical study investigating the use of TGR-1202, TG Therapeutic’s oral PI3K delta inhibitor and TG-1101 (ublituximab), in patients with relapsed or refractory CLL.
TG-1101 is TG Therapeutic’s glycoengineered anti-CD20 monoclonal antibody in combination with pembrolizumab the anti-PD-1 immune checkpoint inhibitor.
"We are very excited about the launch of this combination study and its potential in treating patients with CLL,” Michael S. Weiss, TG Therapeutic’s executive chairman and interim CEO, said. “To date, engaging T-cells to fight CLL has been promising but has yet to produce the dramatic effects seen in other settings.”
This will be the first clinical trial evaluating the safety, tolerability and effectiveness of the triple combination of a PI3K delta inhibitor with an anti-CD20 mAb and an anti-PD-1 checkpoint inhibitor.
“We believe our proprietary TG-1101 plus TGR-1202 regimen in combination with T-cell enhancing therapies, like anti-PD-1, could significantly improve the outcomes for patients with CLL," Weiss said. "Additionally, with our own anti-PD-L1 antibody expected to enter clinical trials next year, this trial will give us a nice head start in designing our proprietary combination clinical program."
TG Therapeutics is a biopharmaceutical company that is focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases.