Abstract: 6 Month Results from a Phase 2 Multicenter Study of Ublituximab, a Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb), in Patients with Relapsing Forms of Multiple Sclerosis (RMS), Demonstrates Complete Elimination of Gd-Enhancing Lesions (2018 Annual Meeting of the Consortium of Multiple Sclerosis Centers)

DX62
6 Month Results from a Phase 2 Multicenter Study of Ublituximab, a Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb), in Patients with Relapsing Forms of Multiple Sclerosis (RMS), Demonstrates Complete Elimination of Gd-Enhancing Lesions

Thursday, May 31, 2018

Exhibit Hall A (Nashville Music City Center)

Matilde Inglese, MD, PhD , Department of Neurology, Radiology and Neuroscience, Mount Sinai School of Medicine, New York, NY

Maria Petracca, MD, PhD , Neurology, Icahn School of Medicine at Mount Sinai, New York, NY

Sirio Cocozza, MD , Neurology, Icahn School of Medicine at Mount Sinai, New York, NY

Sibyl Wray, MD , Hope Neurology MS Center, Knoxville, TN

Michael K Racke, MD , Wexner Medical Center, Ohio State University, Columbus, OH

Richard Shubin, MD , SC3 Research Group, Inc, Pasadena, CA

Cary L Twyman, MD , Associates in Neurology PSC, Lexington, KY, USA, Lexington, KY

Wendy Su, PhD , Autoimmune, TG Therapeutics, Inc, New York, NY

James Eubanks, PhD , Autoimmune, TG Therapeutics, Inc, New York, NY

Koby Mok, PhD , Autoimmune, TG Therapeutics, Inc, New York, NY

Michael Weiss, JD , Autoimmune, TG Therapeutics, Inc, New York, NY

Edward J. Fox, MD, PhD , Central Texas Neurology Consultants, Round Rock, TX

Background: Focal inflammatory lesions underlie the occurrence of relapses in MS, and demyelinating axons are more susceptible to neurodegeneration. Treatment with antiCD20 mAbs have shown significant reduction in MRI and clinical disease activity in RMS patients. Ublituximab is a novel, chimeric mAb which targets a unique epitope on the CD20 antigen and is glycoengineered to enhance affinity for all variants of FcγRIIIa receptors, demonstrating greater antibody dependent cellular cytotoxicity activity than rituximab.

Objectives: To examine the effect of ublituximab on the development of new gadolinium (Gd) enhancing lesions, T2 lesions and T1 hypointense volume at Week 24 in RMS subjects.

Methods: TG1101-RMS201 is a 52-week, phase 2, placebo-controlled, multicenter study that is designed to assess the safety and optimal infusion of ublituximab in RMS subjects. All subjects, including placebo (post-placebo phase), receive 3 ublituximab infusions on Days 1, 15, and Week 24. Number of new Gd-enhancing lesions, T2 lesion volume, and T1 hypointense lesion volume are evaluated on brain MRI scans performed at baseline, Week 24 (pre-dose) and Week 48.

Results: To date, MRI data has been analyzed up to Week 24 in 31 patients, encompassing two ublituximab infusions, data expected on 48 subjects at time of presentation. At baseline, there was a total number of 73 T1 Gd-enhancing lesions (mean 2.4±4.0). At Week 24, total number of T1 Gd-enhancing lesions were reduced to 0 (p= 0.003). Further, T2 lesion volume decreased 8.1% (p=0.01) from baseline to Week 24. The mean T1 hypointense lesions volume decreased 6.6% (p=0.04) from baseline to Week 24.

Conclusions: Ublituximab is well tolerated and 6-month data shows potent B-cell depletion and robust efficacy on MRI endpoints. Additionally, infusion times as low as one hour and lower dose infusions, relative to other anti-CD20’s, provide a convenience benefit for patients.

DX62 6 Month Results from a Phase 2 Multicenter Study of Ublituximab, a Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb), in Patients with Relapsing Forms of Multiple Sclerosis (RMS), Demonstrates Complete Elimination of Gd-Enhancing Lesions

DX62
6 Month Results from a Phase 2 Multicenter Study of Ublituximab, a Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb), in Patients with Relapsing Forms of Multiple Sclerosis (RMS), Demonstrates Complete Elimination of Gd-Enhancing Lesions