On October 5, 2017 TG Therapeutics, Inc. (NASDQ:TGTX), reported that the first patient has been dosed in a Phase 1 clinical trial evaluating the safety and tolerability of its proprietary fully-human anti-PD-L1 monoclonal antibody. This first-in-human, Phase I, open-label, multicenter study is evaluating the safety and tolerability of ascending doses of our anti-PD-L1 monoclonal antibody in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers. Secondary endpoints for this study include the evaluation or characterization of the pharmacokinetics, immunogenicity and preliminary efficacy (Press release, TG Therapeutics, OCT 5, 2017, View Source [SID1234520789]). This study will initially enroll patients in sites across Australia and New Zealand.

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, “We are excited to bring our first immuno-oncology asset into clinical development. This first-in-human study is being conducted in solid tumors to expedite enrollment and enrich for patients most likely to respond to anti-PD-L1 therapy. Once a recommended Phase 2 dose is identified, we plan to commence a study in B-cell malignancies both as a single agent and in combination with our other pipeline products. We have already piloted the concept by combining our proprietary ‘U2′ (TG-1101 + TGR-1202) regimen with the PD-1 inhibitor, pembrolizumab, and believe that experience will speed the development of our proprietary triplet.” Mr. Weiss continued, “As always, our vision is to develop best-in-class combination therapies and we believe adding PD-1/PD-L1 therapy to targeted therapy represents the next generation of treatment options for patients with B-cell malignancies. Advancing our proprietary anti-PD-L1 into the clinic is an important first step in reaching this goal.”