TG Therapeutics Inc. (NASDAQ:TGTX) Reports Positive Phase 2 Umbralsib Study Data and Submits BLA for Ublituximab

TG Therapeutics Inc. (NASDAQ:TGTX) has published Phase 2 umbralisib study data in the American Society of Haematology Journal Blood. Umbralisib is the company’s experimental once per day oral CK1-epsilon and PI3K-delta inhibitor in chronic lymphocytic leukemia (CLL) patients that are intolerant to previous PI3Kdealta or BTTK inhibitor therapy. The publication is entitled, “Phase 2 Study of the Safety and Efficacy of Umbralisib in Patients with CLL Who Are Intolerant to BTK or PI3Kδ Inhibitor Therapy.”

Encouraging umbralisib study data

The company’s CEO, Michael Weiss said that they are encouraged by published data showing that umbralisib induced enhanced progression-free survival and durable responses in intolerant patients to previous BTKi or PI3K delta therapy. Weiss added that even though there is a lot of advancement in CLL treatment in recent times there is still a problem with early kinase inhibitors termination because of tolerability thus leaving CLL patients without therapy alternatives. He said that the company remains committed to delivering therapies for CLL patients following the rolling BLA submission for umbralisib combination with ublituximab in CLL patients.

The published data was from 51 CLL patients that had received BTK or PI3K inhibitor therapy before but became intolerant. Patients received 800mg umbralisib daily with the primary endpoint of the study being progression-free survival. The averaged PFS was 23.5 months with around 58% of CLL patients on umbralisib staying for long compared to previous kinase inhibitors.

TG submits rolling BLA for ublituximab combination with umbralisib

TG Therapeutics also announced the initiation of a rolling Biologics License Application (BLA) submission to the FDA for ublituximab combination with umbralisib approval for CLL treatment. Ublituximab is the company’s experimental glycoengineered anti-CD20 monoclonal antibody. The company had previously received Fast Track Designation for the combination in treating adult CLL patients and Orphan Drug Designation covering umbralisib combination with ublituximab for CLL treatment. TG expects to finalize the rolling BLA submission in 1H 2020.Weiss said that the BLA submission is a huge milestone for the company bringing it closer to delivering combination therapies for CLL patients.