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): May 23, 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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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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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 May 23, 2017, TG
Therapeutics, Inc. (the “Company”) issued a press
release announcing that the independent Data Safety Monitoring
Board (DSMB) of the UNITY-CLL Phase 3 trial has successfully
completed a pre-specified interim analysis to assess the
contribution of TG-1101 (ublituximab) and TGR-1202 in the
combination regimen of TG-1101 plus TGR-1202. 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 May 23, 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 24,
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 May 23, 2017
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TG Therapeutics, Inc. Announces Successful Outcome from Pre-Planned
Interim Analysis by
Independent DSMB in the UNITY-CLL Phase 3 Trial
Contribution of single agents in the combination regimen
successfully established pursuant to the UNITY-CLL Special Protocol
Assessment; DSMB recommends no further enrollment to single agent
arms
DSMB reviewed updated safety data from more than 270 patients,
finding no safety concerns and recommended continuation of
enrollment without modification
Target timeline to complete enrollment updated to by Year-End
2017
New
York, NY, (May 23, 2017) TG
Therapeutics, Inc. (NASDAQ: TGTX), today announced that the
independent Data Safety Monitoring Board (DSMB) of the UNITY-CLL
Phase 3 trial has successfully completed a pre-specified interim
analysis to assess the contribution of TG-1101 (ublituximab) and
TGR-1202 in the combination regimen of TG-1101 plus TGR-1202. In
conducting the analysis, the DSMB reviewed efficacy data from
approximately 50 patients per arm in the UNITY-CLL study who were
eligible for at least one response evaluation. Based on the overall
response rate data available, and in accordance with the
statistical analysis plan in the study’s Special Protocol
Assessment (SPA), the DSMB determined that contribution has been
established and recommended the Company cease enrollment into the
single agent arms. Accordingly, the study will now continue
enrollment in a 1:1 ratio to only the two combination arms: the
investigational arm of TG-1101 (ublituximab) plus TGR-1202 and the
control arm of obinutuzumab plus chlorambucil. Additionally, the
DSMB reviewed safety data from all patients on study (n>270) as
of the data cut-off date, including patients with both treatment
naive and relapsed/refractory Chronic Lymphocytic Leukemia (CLL),
and again identified no safety concerns in any treatment group
(treatment naïve or previously treated) and recommended the
continuation of the study without modification.
“We
are extremely pleased that the DSMB has once again found no safety
concerns that would require modifying the study. This is
particularly comforting when we consider that the safety population
now includes over 60 front-line CLL patients treated for more than
6 weeks with TGR-1202 alone or in combination with TG-1101. As most
who have followed this area will recall, treatment naïve CLL
patients appear to be exquisitely sensitive to the autoimmune
mediated side effects of idelalisib, with approximately 50%
experiencing Grade 3/4 liver toxicity by week 6 in a published
study,” stated Michael S. Weiss, the Company’s
Executive Chairman and Chief Executive Officer. Mr. Weiss
continued, “We are also very pleased that, in accordance with
our SPA, the DSMB has determined that contribution has been
adequately demonstrated, enabling us to eliminate the single agent
arms from continued enrollment. We are also excited to report that
we continue to see strong interest in the study and enrollment
remains robust. We continue to view the demand for this study as a
strong indication of the need for alternative treatments for
patients with CLL, even in the front-line setting. Given the
current rate of enrollment, we are now targeting complete
enrollment by year end, ahead of our previous guidance, which would
put us in a position to report pivotal Overall Response Rate (ORR)
data in the third quarter of 2018.”
ABOUT UNITY-CLL PHASE 3 TRIAL
UNITY-CLL
is a Global Phase 3 randomized controlled clinical trial in
patients with Chronic Lymphocytic Leukemia (CLL) that includes two
key objectives: first, to demonstrate contribution of each agent in
the TG-1101 + TGR-1202 regimen, and second, to demonstrate
superiority in Progression Free Survival (PFS) over the standard of
care to support the submission for full approval of the
combination. In addition, upon completion of enrollment, this trial
will evaluate Overall Response Rate (ORR) for accelerated approval.
The study initially randomized patients into four treatment arms:
TG-1101 plus TGR-1202, TG-1101 single agent, TGR-1202 agent, and an
active control arm of obinutuzumab plus chlorambucil. Pursuant to
the Special Protocol Assessment (SPA) with the U.S. Food and Drug
Administration (FDA), an early interim analysis was conducted to
assess contribution of each single agent which, upon success,
allowed for early termination of both single agent
arms.
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 pre-clinical 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
Some of
the statements included in this press release 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. In addition
to the risk factors identified from time to time in our reports
filed with the Securities and Exchange Commission, factors
that could cause our actual results to differ materially are the
following: our ability to successfully and cost effectively enroll
and complete the UNITY-CLL trial on-time or at all or deliver
pivotal data on schedule; the risk that early clinical trial
results, that may have influenced our decision to proceed with
additional clinical trials, will not be reproduced in future
studies; the risk that safety and/or efficacy data from the interim
analyses from the UNITY-CLL trial will not be consistent with the
final results and/or that the data will not support regulatory
approval; the risk that the combination of TG-1101 and TGR-1202,
referred to as TG-1303, and being studied in the UNITY clinical
trials, will not prove to be a safe and efficacious combination
treatment option for any indication. 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