TG Therapeutics Inc. (NASDAQ: TGTX) Presents Ublituximab Study Data Used To File For Biologics License Application

TG Therapeutics Inc. (NASDAQ: TGTX) has presented data that includes additional analyses from its Phase 3 trials, ULTIMATE I & II, evaluating its novel experimental glycoengineered anti-CD20 monoclonal antibody, ublituximab relative to teriflunomide in relapsed for of Multiple sclerosis (RMS) patients.

ULTIMATE I & II studies met the primary endpoint 

As previously announced, ublituximab treatment resulted in a statistically significant annualized relapse rate (ARR) reduction during a 96-week period in both studies, which met primary study endpoints. In addition, two presentations at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) presented additional results.

CEO Michael Weiss said, “We are excited to share additional data from the ULTIMATE I & II trials during the ECTRIMS 2021 conference. The data further elucidate the potential benefits of ublituximab treatment especially on the tertiary endpoint of improvement in MSFC score, a detailed review of which is the subject of a late breaking e-poster. We look forward to today’s event and hope you all can join us and hear from the key opinion leaders.”

TG Therapeutics filed BLA for Ublituximab

The data from the ULTIMATE I & II Phase 3 trials and new supplementary studies were emphasized in presentations during the 37th ECTRIMS Congress. Following the Day 1 infusion, these studies looked at the efficacy and safety of a one-hour 450mg ublituximab infusion after six months (150mg over four hours). The ULTIMATE I and II studies were carried as per a Special Protocol Assessment agreement with the US FDA. In addition, they served as the foundation for a Biologics License Application (BLA) for ublituximab in RMS, which the company submitted late last month.

Ublitiximab is an experimental monoclonal antibody targeting unique epitope in the CD20-showing B-cells. When the antibody binds to B-cells, it evokes various immunological reactions, including antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. Ublituximab does have sugar molecules expressed on the antibody.