Ublituximab: Phase II started

TG Therapeutics began an open label, U.S. Phase II trial to evaluate IV ublituximab in combination with once-daily oral ibrutinib in about 20 CLL patients and 20 MCL patients. Patients will receive ublituximab on days 1, 8 and 15 of the first 28-day cycle and on day 1 of cycles 2-6. Ublituximab has Orphan Drug designation in the U.S. to treat nodal marginal zone lymphoma and to treat extranodal marginal zone lymphoma (mucosa-associated lymphatic tissue), which are both rare subtypes of non-Hodgkin's lymphoma (NHL), and Orphan Drug designation in Europe and the U.S. for B cell CLL. The compound is in Phase I/II testing to treat relapsed or refractory NHL and to treat B cell lymphoid malignancies in patients previously treated with anti-CD20 antibody therapy.

Last year, TG Therapeutics exercised an option to license exclusive, worldwide rights to develop and commercialize ublituximab from former parent company LFB, which spun out TG Therapeutics in November 2010 (see BioCentury, March 5, 2012). Last November, TG Therapeutics granted Ildong exclusive rights to develop and commercialize ublituximab in South Korea and Southeast Asia (see BioCentury, Nov. 19, 2012). ...