UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
WASHINGTON, D.C. 20549
_____________
FORM 8-K
_____________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the
Securities Exchange Act of
1934
Date of report
(Date of earliest event reported): April 28, 2017
TG Therapeutics, Inc.
(Exact Name of
Registrant as Specified in Charter)
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Delaware
(State or Other
Jurisdiction
of
Incorporation)
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001-32639
(Commission File
Number)
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36-3898269
(IRS Employer
Identification No.)
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2 Gansevoort Street, 9th
Floor
New York, New York 10014
(Address of
Principal Executive Offices)
(212) 554-4484
(Registrant's
telephone number, including area code)
Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
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☐
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Written communications pursuant to Rule 425
under the Securities Act.
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☐
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Soliciting material pursuant to Rule 14a-12
under the Exchange Act.
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☐
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Pre-commencement communications pursuant to Rule
14d-2b under the Exchange Act.
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☐
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Pre-commencement communications pursuant to Rule
13e-4(c) under the Exchange Act.
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Item 8.01. Other Events.
On April 28, 2017,
TG Therapeutics, Inc. (the “Company”) issued a press
release announcing preliminary results from its ongoing Phase 2
study of TG-1101 (ublituximab), the Company's novel glycoengineered
anti-CD20 monoclonal antibody, in patients with relapsing forms of
multiple sclerosis (RMS). The data was presented at the
69th
American Academy of Neurology (AAN) annual meeting, taking place in
Boston, MA. A copy of the press release is being filed as Exhibit
99.1 and incorporated in this Item by
reference.
Item 9.01 Financial Statements And
Exhibits.
(d)
Exhibits.
99.1 Press
Release, dated April 28, 2017.
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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TG Therapeutics, Inc.
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(Registrant)
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Date: May 1,
2017
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By: /s/
Sean A.
Power
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Sean A.
Power
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Chief Financial
Officer
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INDEX
TO EXHIBITS
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Exhibit
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Number
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Description
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99.1.
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Press Release,
dated April 28, 2017
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TG Therapeutics Announces Preliminary Results from Ongoing Phase 2
Study of TG-1101 (ublituximab) in Patients with Multiple
Sclerosis at the American
Academy of Neurology 69th Annual Meeting
MS patients treated with TG-1101 exhibited median B-cell depletion
of 99% at week 4
TG-1101 was well tolerated with no grade 3/4 adverse events
reported, with median time on study of 5 months
NEW
YORK, April 28, 2017 -- TG Therapeutics, Inc. (NASDAQ:TGTX) today
announced preliminary results from its ongoing Phase 2 study of
TG-1101 (ublituximab), the Company's novel glycoengineered
anti-CD20 monoclonal antibody, in patients with relapsing forms of
multiple sclerosis (RMS). The data is being presented today at the
69th
American Academy of Neurology (AAN) annual meeting, taking place in
Boston, MA. The poster is available for viewing during poster
session 6, from 8:30 AM – 5:30 PM ET.
The
poster, entitled “Preliminary results 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) demonstrates rapid and robust B cell
depletion“ (Abstract Number: 3113; Poster number 6.348),
includes data from 24 patients with RMS treated with TG-1101. Three
dosing cohorts of up to 8 patients each were evaluated to assess
the safety and tolerability of TG-1101 at accelerated
infusion.
Highlights from the poster include:
●
TG-1101 was well
tolerated with no Grade 3/4 adverse events observed and the most
commonly report AE being infusion related reactions, with median
time on study of 5 months
●
All scheduled doses
were fully delivered to all subjects to date
●
The independent
DSMB reviewed safety data for each cohort periodically and approved
continuation of the study at each review based on acceptable safety
measures
●
All patients met
the primary end-point of >95% B-cell depletion by 4
weeks
●
The
median B-cell depletion at week 4 was 99% after two infusions (Day
1 and 15) with a cumulative dose of 600mg, which compares favorably
with other anti-CD20 monoclonal antibodies
“We
are highly encouraged by the data presented today demonstrating
that TG-1101 is a potent and effective B-cell depleting agent. With
the recent approval of ocrelizumab, B-cell depletion therapy is now
recognized as a highly efficacious treatment option for patients
with MS. We look forward to following these patients and reporting
on established MS efficacy endpoints later this year, which require
longer-term follow-up,” stated Michael S. Weiss, the
Company's Executive Chairman and Chief Executive Officer. Mr. Weiss
continued, “We believe TG-1101 represents an exciting option
in the treatment of MS and believe this Phase 2 trial sets the
stage for our Phase 3 program that we expect to commence in the
coming months.”
“Information
gained from this Phase 2 ublituximab trial has helped guide the
development of the Phase 3 program, and will further the process of
gaining a new innovative treatment option for patients with
MS. The investigators in the clinical trial are pleased with
the results thus far, and look forward to the full data set in the
future,” stated Edward Fox, MD, PhD, Director of
the Multiple Sclerosis Clinic of Central Texas and Clinical
Assistant Professor at the University of Texas Medical
Branch in Round Rock, TX, and the Principal Investigator
for this Phase 2 study.
“The
preliminary analysis of the immune profiles demonstrate efficient
B-cell depletion occurs with ublituximab therapy. We are
excited by the potential of ublituximab to provide patients with
another treatment option and look forward to further exploring the
immune profiling data to perhaps shed light on how B-cell depletion
ameliorates MS progression. Understanding how B-cell depletion
alters the immune response may also help us understand mechanisms
that underlie the pathology of MS, also an area that is not fully
understood,” stated Amy Lovett-Racke, PhD, Professor of the
Department of Microbial Infection and Immunity at the Ohio State
University Medical Center in Columbus, OH.
POSTER
PRESENTATION DETAILS
A copy
of the poster presentation is available on the Company’s
website at www.tgtherapeutics.com,
located on the Publications Page, within the Pipeline
section.
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. TG-1101 (ublituximab) 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 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 TG-1101 and TGR-1202 are in clinical
development for patients with hematologic malignancies, with
TG-1101 recently entering clinical development for autoimmune
disorders. The Company also has preclinical programs to develop
IRAK4 inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR
antibodies. 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, as well as anticipating the timing of the release
of additional data from our Phase 2 MS trial and commencement 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 trial; 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 the clinical results from the MS Phase 3 program, if
conducted, will be not positive and/or will not support regulatory
approval of TG-1101 for MS;the risk that TG-1101 will not have a
differentiated profile from the other drugs in the class;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.
TGTX -
G
CONTACT:
Jenna
Bosco
Vice President,
Investor Relations
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email: ir@tgtxinc.com