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Abstract Details

Open Label Extension (OLE) of Phase 2 Multicenter Study of Ublituximab (UTX), a Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb), in Patients with Relapsing Forms of Multiple Sclerosis (RMS)
Multiple Sclerosis
P3 - Poster Session 3 (5:30 PM-6:30 PM)
15-048
To evaluate the safety/tolerability and long-term disability outcomes of ublituximab (UTX) treatment in RMS patients enrolled in the OLE. 

UTX is a novel mAb targeting a unique epitope on the CD20 antigen and glyco-engineered for enhanced B cell targeting through antibody-dependent cellular cytotoxicity (ADCC). The greater ADCC potency may offer a benefit over currently available anti-CD20s in terms of lower doses and shorter infusion times.

TG1101-RMS201 was a 52-week, phase 2, placebo-controlled, multicenter study designed to assess the optimal dose and infusion time of UTX in RMS subjects. Subjects who completed the RMS201 study were eligible to continue treatment in an OLE, receiving one-hour 450mg UTX infusions every 24 weeks for an additional 96 weeks. Safety is monitored throughout the OLE with EDSS assessments performed every 48 weeks. 

48 subjects were enrolled in the Phase 2 study. Median B cell depletion of >99% was observed at Week 4 and maintained at Week 48. At Week 48, T1-Gd enhancing lesions decreased from a baseline mean of 3.63 to zero; mean T2 lesion volume decreased 10.6% from baseline; 93% of subjects were relapse free and an ARR of 0.07 was observed. Most common adverse events (AEs) were infusion related reactions (all grade 1-2). No discontinuations due to severe AEs were reported. 37 subjects from the Phase 2 trial enrolled in the OLE. As of October 2018, approximately 30% of patients completed 48 weeks in the OLE. UTX continues to be well tolerated, with no discontinuations due to AEs. At the time of presentation, it is anticipated that additional patient follow-up from the OLE study will be available.

The Phase 2 OLE supports that one-hour infusions of UTX continue to be safe and well tolerated. These results support the ongoing Phase 3 ULTIMATE program in RMS.   
Authors/Disclosures
Edward Fox, MD, PhD, FAAN
PRESENTER
Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion Pharmaceuticals. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GW Pharmaceuticals. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Bristol Myers Squibb. The institution of Dr. Fox has received research support from Biogen. The institution of Dr. Fox has received research support from Genentech. The institution of Dr. Fox has received research support from Celgene - BMS. The institution of Dr. Fox has received research support from Chugai. The institution of Dr. Fox has received research support from Novartis. The institution of Dr. Fox has received research support from EMD-Serono. The institution of Dr. Fox has received research support from TG Therapeutics. The institution of Dr. Fox has received research support from AbbVie. The institution of Dr. Fox has received research support from Sanofi Genzyme. The institution of Dr. Fox has received research support from AbbVie.
Sibyl E. Wray, MD (Hope Neurology) Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Wray has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb/Celgene. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi/Genzyme. Dr. Wray has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for EMD Serono. Dr. Wray has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Roche/Genentech. Dr. Wray has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi/Genzyme. The institution of Dr. Wray has received research support from Biogen. The institution of Dr. Wray has received research support from Atara Biotherapeutics. The institution of Dr. Wray has received research support from Bristol Myers Squibb/Celgene. The institution of Dr. Wray has received research support from Novartis. The institution of Dr. Wray has received research support from Roche/Genentech. The institution of Dr. Wray has received research support from Sanofi/Genzyme. The institution of Dr. Wray has received research support from TG Therapeutics. The institution of Dr. Wray has received research support from EMD Serono. The institution of Dr. Wray has received research support from Pharmaceuticals Corp..
Richard A. Shubin, MD No disclosure on file
No disclosure on file
No disclosure on file
Sean Power Sean Power has received personal compensation for serving as an employee of TG Therapeutics, Inc. Sean Power has received stock or an ownership interest from TG Therapuetics, Inc..
Koby Mok, PhD (TGTX) Dr. Mok has received personal compensation for serving as an employee of TG Therapeutics. Dr. Mok has received stock or an ownership interest from TG Therapeutics.
No disclosure on file