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): August 1, 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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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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Indicate by check
mark whether the registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 (17 CFR
§230.405) or Rule 12b-2 of the Securities Exchange Act of 1934
(17 CFR §240.12b-2). Emerging growth company
☐
If an emerging
growth company, indicate by check mark if the registrant has
elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01. Other Events.
On
August 1, 2017, TG Therapeutics, Inc. (the “Company”)
issued a press release announcing it has reached an agreement with
the U.S. Food and Drug Administration (FDA) regarding a Special
Protocol Assessment (SPA) on the design of two Phase 3 clinical
trials for TG-1101 (ublituximab), the Company’s
glycoengineered anti-CD20 monoclonal antibody, for the treatment of
relapsing forms of Multiple Sclerosis (RMS). A copy of the press
release is being filed as Exhibit 99.1 and is incorporated herein
by reference.
Item 9.01 Financial Statements And
Exhibits.
(d)
Exhibits.
99.1 Press
Release, dated August 1, 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: August 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 August 1, 2017.
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TG Therapeutics Announces Special Protocol Assessment (SPA)
Agreement with the FDA for a Phase 3 Program of TG-1101
(ublituximab) for Patients with Multiple Sclerosis
(MS)
Global Phase 3 Program Expected to Commence Before End of Q3
2017
International Phase 3 Trials Entitled “ULTIMATE I” and
“ULTIMATE II” to be Led by Lawrence Steinman, MD, of
Stanford University
NEW
YORK, August 1, 2017– TG Therapeutics, Inc. (Nasdaq: TGTX)
announced today that it has reached an agreement with the U.S. Food
and Drug Administration (FDA) regarding a Special Protocol
Assessment (SPA) on the design of two Phase 3 clinical trials for
TG-1101 (ublituximab), the Company’s glycoengineered
anti-CD20 monoclonal antibody, for the treatment of relapsing forms
of Multiple Sclerosis (RMS). The SPA provides agreement that the
two Phase 3 trial designs adequately address objectives that, if
met, would support the regulatory submission for approval of
TG-1101.
The RMS
Phase 3 program consists of two trials, called the ULTIMATE I and
ULTIMATE II trials. Each trial is a global, randomized,
multi-center, double-blinded, double-dummy, active-controlled study
comparing TG-1101 (ublituximab) to teriflunomide in subjects with
RMS. The primary endpoint for each study is Annualized Relapse Rate
(ARR) following 96 weeks of treatment. Each trial will enroll
approximately 440 subjects, randomized in a 1:1 ratio, with
approximately 880 patients to be enrolled across both
trials.
Lawrence
Steinman, MD, George A. Zimmermann Professor and Professor of
Pediatrics, Neurology and Neurological Sciences at Stanford
University, and global study chair for both ULTIMATE I and ULTIMATE
II trials commented, “B-cell targeted therapy with anti-CD20
monoclonal antibodies has been shown to be very active in the
treatment of multiple sclerosis, and with the recent approval of
ocrelizumab, we have entered a new era of B-cell targeted therapy
for MS. The Phase 2 data recently presented for ublituximab
demonstrates an encouraging safety and efficacy profile in the
treatment of MS with this novel glycoengineered anti-CD20
monoclonal antibody. We are excited to lead this global Phase 3
program, and believe the unique attributes of ublituximab, in
particular the rapid infusion times and potential pricing
advantages, may provide added convenience and enhance patient care
and access over currently available therapies.”
Michael
S. Weiss, Executive Chairman and Chief Executive Officer of TG
Therapeutics, stated "Reaching agreement with the FDA on the design
of our Phase 3 program for TG-1101 in RMS has been a priority for
us and we would like to thank the FDA for its invaluable guidance
throughout this process. We have long believed the potential of
TG-1101 is beyond oncology and believe this significant Phase 3
program will establish TG-1101 as an important new drug in the
treatment of MS. The early data from our Phase 2 clinical trial,
the highly successful pivotal results for the anti-CD20 monoclonal
antibody ocrelizumab in MS, and the substantial safety data
generated in our oncology program, gives us a high level of
confidence in the potential for a successful outcome.” Mr.
Weiss continued, “Our team in concert with our CRO has been
hard at work on the logistics and the launch of these Phase 3
trials on a global basis, and we look forward to enrolling our
first patient before the end of the summer.”
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 also in 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.
About Special Protocol Assessments
The
Special Protocol Assessment (SPA) process is a procedure by which
the FDA provides official evaluation and written guidance on the
design and size of proposed protocols that are intended to form the
basis for a new drug application.
Final
marketing approval depends on the results of efficacy, the adverse
event profile and an evaluation of the benefit/risk of treatment
demonstrated in the Phase 3 clinical program. The SPA agreement may
only be changed through a written agreement between the sponsor and
the FDA, or if the FDA becomes aware of a substantial scientific
issue essential to product efficacy or safety. For more information
on Special Protocol Assessment, please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf.
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 the timing of the
first patient enrolled into 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, 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 some of the perceived attributes of TG-1101, in particular the
infusion times and potential pricing advantages may not be
incorporated into future plans 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
Jenna
Bosco
Vice President -
Investor Relations
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email: ir@tgtxinc.com