Rapid and Robust B Cell Depletion in Preliminary Results of a Phase 2 Study of Ublituximab, Novel Glycoengineered Anti-CD20 Mab, in RMS Patients
Objectives: To determine the level of B cell depletion by ublituximab in subjects with RMS
Methods: TG1101-RMS201 is a 52-week, phase 2, placebo-controlled, multicenter study that is designed to assess the infusion time and optimal dose as well as safety/tolerability of UTX in RMS subjects. Radiological and clinical analysis are also performed. Optimal dosing is determined by B cell depletion, defined as percentage of CD19+ B cells present following UTX administration. This is calculated by gating the entire lymphocyte/myeloid population. Within this population, CD19+ CD3- cells were gated and % CD19+B cells was determined.
Results: To date, B cell data from 11 subjects have been analyzed up to week 4 of the 52-week study, encompassing two infusions of UTX. Further, no SAEs have been reported, including subjects receiving rapid UTX infusions. Only patients whose B cells were within a normal range (≥5% of total lymphocytes) at screening were included in the study. At week 4 (1 week post second infusion), median B cell depletion was 99% from baseline in UTX treated subjects, while placebo subjects maintained similar B cell levels as compared to baseline. [Data from ≥24 patients, will reported at the conference.]
Conclusions: Ublituximab, a novel glycoengineered anti-CD20 antibody, is well tolerated and demonstrates rapid and robust B cell depletion. Unlike other anti-CD20s, ublituximab can be delivered in shorter infusions, providing a convenience benefit for patients.