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): March 6, 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 March 6, 2017 TG
Therapeutics, Inc. issued a press release in which it reported
topline results from its Phase 3
GENUINE clinical trial of TG-1101 (ublituximab) plus ibrutinib in
patients with previously treated high risk chronic lymphocytic
leukemia (CLL). 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 March 6, 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: March 6,
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 March 6, 2017
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TG Therapeutics Announces Positive Topline Data from Phase 3
GENUINE Study of TG-1101 in Combination with Ibrutinib in Patients
with High Risk Chronic Lymphocytic Leukemia (CLL)
Study met its primary endpoint, with TG-1101 (ublituximab) plus
ibrutinib increasing Overall Response Rate (ORR) by >70% over
ibrutinib alone
The combination was well tolerated with a safety profile consistent
with the Phase 2 study of ublituximab plus ibrutinib recently
published in the British Journal of Haematology
Targeting full data presentation at a medical meeting in 1H17 and
meeting with FDA in 2H17 to discuss the results and filing for
accelerated approval
Conference call to be held today, Monday March 6,
2017 at 8:30 am ET, with Dr. Anthony Mato from the
University of Pennsylvania, a lead enroller in the GENUINE
trial
New York, NY, March 6, 2017 – TG Therapeutics
(NASDAQ:TGTX) today announced positive topline results from its
Phase 3 GENUINE clinical trial of TG-1101 (ublituximab) plus
ibrutinib in patients with previously treated high risk Chronic
Lymphocytic Leukemia (CLL). For the study, high risk was defined as
having any one or more of the following: 17p deletion, 11q deletion
or p53 mutation.
The multicenter, randomized trial (NCT02301156), which assessed the
efficacy and safety of TG-1101 plus ibrutinib, met its primary
endpoint, demonstrating a statistically significant improvement in
Overall Response Rate (ORR) compared to ibrutinib alone in both the
Intent to Treat (ITT) population (p=0.001) and Treated population
(p<0.001). The ITT population includes all 126 randomized
patients (64 in the TG-1101 + ibrutinib arm and 62 in the ibrutinib
alone arm) while the Treated population includes all ITT patients
that received at least one dose of either study drug (59 in the
TG-1101 + ibrutinib arm and 58 in the ibrutinib alone
arm).
Overall Response Rates
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TG-1101 plus Ibrutinib
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Ibrutinib
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P-value
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Treated Population (n)
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n=59
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n=58
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Overall Response Rate
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80%
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47%
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P<0.001
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All
responses were assessed by independent blinded central review using
the iwCLL 2008 guidelines. Per iwCLL guidelines, responders require
confirmation of response for a minimum duration of 2 months. As of
the date of the analysis, each arm had responders that were
awaiting confirmation visits which are scheduled to occur over the
next two months. During the study it was infrequent (less than 3%
in the combination arm) for initial responses to fail to be
confirmed. Median follow-up for the study was approximately 12
months.
The
GENUINE study was designed to demonstrate the value of adding
TG-1101, a highly potent next
generation glycoengineered anti-CD20 monoclonal antibody to
ibrutinib monotherapy in high risk CLL, and was powered to show a
statistically significant improvement in ORR, with a minimal
absolute detectable difference between the two arms of
approximately 20%. The absolute difference between the arms was
approximately 30% resulting in a p-value of < 0.001. Results from
registration directed studies included in the ibrutinib prescribing
information demonstrate single agent ibrutinib response rates
ranging from 43% to 58% in patients with previously treated CLL,
with the findings from the GENUINE study of 47% ORR for ibrutinib
fitting well within historical experience.
In addition to ORR, observed advantages were seen for the
combination in a number of secondary and other efficacy measures,
including radiographic Complete Response (CR) rate, Progression
Free Survival and Time to Response. Sufficient data on MRD
negative status and bone marrow confirmation of radiographic CRs
were not available at the time of analysis. From a safety
standpoint, the combination was well tolerated with a safety
profile consistent with the Phase 2 study of ublituximab plus
ibrutinib recently published in the British Journal of
Haematology.
A full analysis of the Phase 3 GENUINE data along with detailed
efficacy and safety results will be submitted for presentation at a
medical meeting in the first half of 2017 and the Company plans to
meet with the FDA as soon as possible thereafter to discuss the
filing of the data for accelerated approval.
"TG-1101 is a highly potent next generation glycoengineered
anti-CD20 monoclonal antibody. We believe the data today
demonstrate that the addition of TG-1101 to ibrutinib enhances the
therapeutic benefit of ibrutinib in patients with previously
treated high risk CLL, the patient population with the poorest
outcome on ibrutinib. We believe the results observed in the
combination arm are extremely compelling and the regimen has the
potential to become the standard of care for treating patients with
high risk CLL that have progressed from other therapies," said
Michael S. Weiss, Executive Chairman and Chief Executive Officer of
TG Therapeutics. Mr. Weiss continued, "We believe that using
combination therapy to accelerate and deepen response in poor
prognosis high risk CLL is critically important for patient
outcomes and we look forward to sharing these data with the FDA in
the coming months to discuss filing for accelerated approval. Most
importantly, we would like to thank the investigators and their
patients for participating in this significant
research."
Dr.
Jeffrey Sharman, the GENUINE Phase 3 Study Chair and the Medical
Director for Hematology Research for the US Oncology Network,
commenting on the results stated, “Ibrutinib has been a great
addition to our CLL armamentarium, however we have long believed
that ibrutinib alone may not be enough, particularly for patients
with high-risk disease. This study demonstrates that the
addition of ublituximab, can significantly enhance the response
rates without compromising safety. We believe that the rapid
responses seen in our Phase 2 study with ublituximab plus ibrutinib
are validated here in our Phase 3 GENUINE study and are important
markers of improved overall efficacy and patient outcomes. I
look forward to the presentation of the results at an upcoming
medical meeting.”
ABOUT THE PHASE 3 GENUINE STUDY
The Phase 3 GENUINE study is a randomized, open label, multicenter
clinical trial to evaluate the safety and efficacy of TG-1101
(ublituximab) plus ibrutinib compared to ibrutinib alone in adult
patients with high risk Chronic Lymphocytic Leukemia (CLL) who
received at least one prior therapy for their disease.
The study was conducted at 160 clinical trial sites in the US and
Israel and randomized 126 patients. Patients received ibrutinib
orally at 420 mg once daily in both arms and in the treatment arm
those patients also received intravenous infusions of TG-1101 at
900 mg dosed on days 1, 8 and 15 of cycle 1 and day 1 of cycles
2-6. Patients in the treatment arm who had not progressed received
quarterly infusions of TG-1101 maintenance at 900 mg.
CONFERENCE CALL INFORMATION
The
Company will host a conference call today, Monday March 6, 2017 at
8:30 am ET to discuss
the Phase 3 GENUINE Trial Topline Data.
In
order to participate in the conference call, please call
1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.),
Conference Title: TG Therapeutics Phase 3 GENUINE Topline Data
Call. A live webcast of this presentation will be available on the
Events page, located within the Investors & Media section, of
the Company's website at www.tgtherapeutics.com. An audio recording
of the conference call will also be available for replay at
www.tgtherapeutics.com, for a period of 30 days after the
call.
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
Statements
included in this press release, including without limitation those
with respect to expected results and results to date of the GENUINE
Phase 3 study, the potential efficacy of TG-1101 in combination
with ibrutnib, anticipating the timing of and data to be included
in the full presentation and analysis of the GENUINE Phase 3 data,
the willingness of the FDA to review the data for approval and any
likelihood of FDA approval or disapproval and the timing of filing
of a BLA for TG-1101, if any 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 GENUINE or the UNITY-CLL trials;
the risk that the clinical results from the GENUINE or UNITY-CLL
studies will be not positive and/or will not support regulatory
approval of TG-1101 or TGR-1202;the risk that the pending GENUINE
confirmation scans may have a negative effect on the topline data
presented;the risk that the FDA will not grant us a pre-BLA meeting
to discuss the results of the GENUINE study; the risk that we will
not file a BLA for TG-1101 or an NDA for TGR-1202 based on either
the GENUINE trial or the UNITY-CLL trial; the risk that despite
early positive trends in enrollment in the UNITY-CLL study that
enrollment will be delayed beyond our projections; the risk that
the planned interim analysis will not allow early closure of the
single agent arms in the UNITY-CLL study, necessitating enrollment
beyond the projected 450 patients, which would extend enrollment
beyond our projections; the risk that safety issues or trends will
be observed in the GENUINE study or the UNITY-CLL study that
prevent approval of either TG-1101 and/or TGR-1202 or require us to
terminate either the GENUINE study or the UNITY-CLL study prior to
completion; the risk that the data (both safety and efficacy) from
future clinical trials will not coincide with the data produced
from prior pre-clinical and clinical trials; the risk that the
GENUINE study, as amended or the UNITY-CLL study, or any of our
other registration-directed clinical trials as designed or amended
may not be sufficient or acceptable to support regulatory approval;
the risk that trials will take longer to enroll than expected; the
risk that the projected cost savings to be realized by amending the
GENUINE trial will not be realized; 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