Blueprint
TG Therapeutics, Inc. Announces Updated Results from the Ongoing
Phase 2 Study of Ublituximab in Patients with Multiple Sclerosis at
the 4th
Congress of the European Academy of Neurology
New
York, NY, (June 18, 2018) TG
Therapeutics, Inc. (NASDAQ: TGTX), today announced updated results
from the Phase 2 multicenter trial of ublituximab (TG-1101), the
Company’s novel glycoengineered anti-CD20 monoclonal
antibody, in relapsing forms of Multiple Sclerosis (RMS). The data
is being presented today at the 4th Congress of the
European Academy of Neurology in Lisbon, Portugal, via an oral
session titled “MS and related Disorders 2”, at 17:00
CET.
Michael
S. Weiss, the Company’s Executive Chairman and Chief
Executive Officer, stated, “We are extremely pleased to see
that the preliminary Week 48 data presented today from this Phase 2
trial supports the Week 24 data presented earlier this year at the
AAN meeting. While only an early look at the Week 48 timepoint, the
data continue to be impressive and suggestive of a highly
efficacious anti-CD20 monoclonal antibody with a manageable safety
profile that can be administered in a convenient one-hour infusion.
Mr. Weiss continued, “We look forward to presenting the final
results from this Phase 2 trial including Week 48 data on up to 48
patients at a major medical meeting later this
year.”
Oral
Presentation Title: Phase 2 Multicenter Study Results of
Ublituximab, a Novel Glycoengineered AntiCD20 Monoclonal Antibody
(mAb), in Patients with Relapsing Multiple Sclerosis
(RMS)
This Phase 2 trial is a 48-week randomized, placebo controlled,
multi-center study evaluating the safety and efficacy of
ublituximab at accelerated infusion times as fast as one hour.
Today’s oral presentation includes Week 24 data from 48
patients with relapsing forms of multiple sclerosis (RMS) that were
treated with ublituximab across six dosing cohorts, as well as data
from the first 14 patients through Week 48.
Highlights:
●
An Annualized
Relapse Rate (ARR) of 0.07, calculated cumulatively, based on 48
subjects with a mean follow-up of approximately 11
months
●
99% median B-cell
depletion was observed at week 4 and maintained at Week 24
(n=44)
●
Ublituximab
completely eliminated all (100%) of T1 Gd-enhancing lesions at Week
24 (n=44) (p=0.003) and at Week 48 (n=14)
●
7.67% Reduction in
T2 lesion volume at Week 24 from baseline(n=44) and a 10.5%
reduction in T2 lesion volume at Week 48 from baseline
(n=14)
●
Ublituximab was
well tolerated across all patients including those receiving rapid
infusions, as low as a one hour for the 450mg Phase 3
dose
These data presentations support the international Phase 3 ULTIMATE
program evaluating ublituximab for the treatment of relapsing forms
of Multiple Sclerosis (RMS). The Phase 3 trials, entitled ULTIMATE
I and ULTIMATE II, are being conducted under Special Protocol
Assessment (SPA) agreement with the U.S. Food and Drug
Administration (FDA) and are being led by Lawrence Steinman, MD, of
Stanford University. The ULTIMATE trials are currently enrolling
and complete enrollment is expected by the end of
2018.
POSTER
A copy
of the above poster can be found on the Publications page, located
within the Pipeline section, of the Company’s website at
www.tgtxinc.com/publications.cfm.
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a
biopharmaceutical company focused on the acquisition, development
and commercialization of novel treatments for B-cell malignancies
and autoimmune diseases. Currently, the company is developing two
therapies targeting hematological malignancies and autoimmune
diseases. Ublituximab (TG-1101) is a novel, glycoengineered
monoclonal antibody that targets a specific and unique epitope on
the CD20 antigen found on mature B-lymphocytes. TG
Therapeutics is also developing umbralisib (TGR-1202), an
orally available PI3K delta inhibitor. The delta isoform of PI3K is
strongly expressed in cells of hematopoietic origin and is believed
to be important in the proliferation and survival of
B‐lymphocytes. Both ublituximab and umbralisib, or the
combination of which is referred to as "U2", are in Phase 3
clinical development for patients with hematologic malignancies,
with ublituximab also in Phase 3 clinical development for Multiple
Sclerosis. Additionally, the Company has recently brought its
anti-PD-L1 monoclonal antibody into Phase 1 development and aims to
bring additional pipeline assets into the clinic in the
future. TG Therapeutics is headquartered in New
York City.
Cautionary Statement
Statements
included in this press release, particularly those with respect to
anticipating the benefit of the early data seen in the Phase 2 MS
trial and anticipating the timing of our MS Phase 3 program may be
forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection
of the safe harbor for forward-looking statements contained in the
Private Securities Litigation Reform Act of 1995. Among the
factors that could cause our actual results to differ materially
are the following: our ability to successfully and cost-effectively
complete the MS Phase 2 and Phase 3 trials; the risk that early
clinical results that supported our decision to move forward will
not be reproduced in additional patients in expansion cohorts or in
the MS Phase 3 program; the risk that data included in any poster
presentation will not be reproduced in subsequent data
presentations; the risk that the clinical results from the MS Phase
3 program, will not be positive and/or will not support regulatory
approval of ublituximab for MS; the risk that ublituximab will not
have a differentiated profile from the other drugs in the class and
that early signs of best-in-class attributes will not be supported
by future results; the risk that trials will take longer to enroll
than expected; our ability to achieve the milestones we project
over the next year; our ability to manage our cash in line with our
projections, and other risk factors identified from time to time in
our reports filed with the Securities and Exchange Commission.
Any forward-looking statements set forth in this press
release speak only as of the date of this press release. We do not
undertake to update any of these forward-looking statements to
reflect events or circumstances that occur after the date hereof.
This press release and prior releases are available
at www.tgtherapeutics.com.
The information found on our website is not incorporated by
reference into this press release and is included for reference
purposes only.
CONTACT:
Jenna
Bosco
SVP, Corporate
Communications