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): October 16, 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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☐
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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
October 16, 2017, TG Therapeutics, Inc. issued the following press
releases: (i) a press release providing an update on an FDA meeting
for the GENUINE Phase 3 trial; (ii) a press release announcing the
completion of full enrollment in the UNITY-CLL Phase 3 trial; and
(iii) a press release recapping clinical data presentations at the
upcoming 7th Joint
ECTRIMS-ACTRIMS Meeting (collectively, the “Press
Releases”). Copies of the Press Releases are being filed as
Exhibits 99.1, 99.2 and 99.3 and incorporated in this Item by
reference.
Item 9.01 Financial Statements And
Exhibits.
(d)
Exhibits.
99.1 Press
Release, dated October 16, 2017.
99.2 Press
Release, dated October
16,
2017.
99.3 Press
Release, dated October 16,
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:
October 17,
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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Press Release,
dated October 16,
2017.
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Press Release,
dated October 16,
2017.
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Press Release,
dated October 16,
2017.
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TG Therapeutics Provides Update on FDA Meeting for GENUINE Phase 3
Trial
Follow-up meeting with FDA expected before year end
NEW
YORK, October 16, 2017 - TG Therapeutics (NASDAQ: TGTX) announced
today that it has met with the U.S. Food and Drug Administration
(FDA) regarding the use of the results from the GENUINE Phase 3
trial to support a Biologics License Application (BLA) filing for
approval of TG-1101 (ublituximab), the Company's novel
glycoengineered anti-CD20 monoclonal antibody, in combination with
ibrutinib. During the meeting, the FDA confirmed that accelerated
approval based on Overall Response Rate (ORR) would be a review
issue. As part of the discussion, the FDA encouraged the Company to
consider future available therapy in its risk/benefit analysis as
part of any potential future BLA filing that may impact accelerated
approval.
The
Company and the FDA also discussed the potential use of Progression
Free Survival (PFS) results from the GENUINE trial to support the
full approval of TG-1101. The Company plans to have a follow-up
meeting with the FDA to discuss the use of the PFS endpoint in more
detail before the end of the year and also plans to monitor the
regulatory landscape for new approvals of agents for previously
treated high-risk Chronic Lymphocytic Leukemia (CLL) while
continuing to make preparations for a BLA filing as early as
2Q18.
Michael
S. Weiss, Executive Chairman and Chief Executive Officer, stated,
“We had a very productive meeting with the FDA regarding the
GENUINE study and its use for approval of TG-1101 in combination
with ibrutinib. We look forward to our follow-up meeting and
working with the FDA in an effort to reach an agreement on the
potential use of PFS for full approval in a similar timeframe as
accelerated approval.” Mr. Weiss continued, “We were
also pleased to announce today the early completion of UNITY-CLL,
which makes the potential filing timelines for GENUINE and
UNITY-CLL now nearly overlapping, setting the stage for an exciting
2018.”
ABOUT THE PHASE 3 GENUINE TRIAL
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.
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
(umbralisib), 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, or the
combination of which is referred to as “U2”, are in
Phase 3 clinical development for patients with hematologic
malignancies, with TG-1101 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
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: the risk that the clinical results from the GENUINE
trial or the UNITY-CLL trial may not be sufficient or may not
support regulatory approval of TG-1101 or TGR-1202; the risk that
the company will not be able to deliver data or updates on schedule
as planned; the risk that
a filing based on UNITY-CLL, GENUINE or any other
registration-direct trials cannot be made on schedule as targeted
or at all; the risk that the filing timelines for GENUINE and
UNITY-CLL do not overlap or do not occur at all; the risk that the
company will not file a BLA for TG-1101 based on the GENUINE trial;
the risk that the regulatory landscape for available therapies
changes prior to a potential approval of TG-1101 based on GENUINE
in a way that prevents an accelerated approval; the risk that the
Company and FDA are not able to reach an agreement on the use of
the PFS endpoint for full approval or, if an agreement is reached,
that the PFS results are not positive and supportive of
approval;the risk that safety issues or trends will be observed in
the GENUINE or UNITY-CLL studies that prevent approval; the risk
that the company decides not to use the GENUINE trial results to
seek accelerated approval of TG-1101;the risk that early clinical
trial results, that may have influenced our decision to proceed
with additional clinical trials, will not be reproduced in the
final data. 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
TG Therapeutics Announces Completion of Full Enrollment in
the UNITY-CLL Phase 3 Trial
Top-Line ORR data from the UNITY-CLL trial expected in
2Q18
Targeting an NDA/BLA filing for combination of TGR-1202 + TG-1101
in 2H18
NEW
YORK, October 16, 2017 - TG Therapeutics (NASDAQ: TGTX) announced
today that it has completed full enrollment in the UNITY-CLL Phase
3 clinical trial. The UNITY-CLL Phase 3 trial is a randomized study
of TG-1101 (ublituximab), the Company's novel glycoengineered
anti-CD20 monoclonal antibody, in combination with TGR-1202
(umbralisib), the Company's PI3K delta inhibitor (together referred
to as the U2 regimen), compared to an active control arm of
obinutuzumab plus chlorambucil, in patients with both treatment
naïve and relapsed or refractory Chronic Lymphocytic Leukemia
(CLL). The UNITY-CLL trial is being conducted under Special
Protocol Assessment (SPA) agreement with the Food and Drug
Administration (FDA).
Last
month, the Company announced that target enrollment of 175 patients
in each of the TG-1101 plus TGR-1202 and obinutuzumab plus
chlorambucil arms was achieved, however, enrollment was extended to
allow eligible patients who were already identified or in screening
the ability to participate in the study. Completion of full
enrollment has now been achieved with more than 200 patients in
each of the two combination arms. Approximately 60% of patients
enrolled in the combination arms were front-line and 40% were
previously-treated. As per the SPA, the primary and secondary
endpoint analyses will include all patients. Top-line Overall
Response Rate (ORR) data from the UNITY-CLL trial is expected in
the second quarter of 2018 and the company is targeting a New Drug
Application (NDA)/ Biologics License Application (BLA) filing for
the combination of TGR-1202 and TG-1101 in the second half of
2018.
Michael
S. Weiss, Executive Chairman and Chief Executive Officer, stated,
“We are pleased to report that UNITY-CLL has now completed
full enrollment, far exceeding the original targeted enrollment and
doing so much faster than anticipated. We believe the tremendous
demand for this study underscores the need for new treatment
options for CLL patients as well as the enthusiasm specifically for
the U2 regimen. Additionally, with the early completion of
UNITY-CLL, the potential filing timelines for GENUINE and UNITY-CLL
are now nearly overlapping, with a UNITY-CLL filing based on ORR
possible as early as 3Q18.” Mr. Weiss continued, “Our
goal is to extend quality life for patients with CLL by developing
efficacious treatments that are well-tolerated, easy to use and
don’t require harsh chemotherapy or hospital admission to
receive therapy. We believe U2 possesses these attributes and has
the potential to become one of the dominant treatment options for
first and second line CLL.”
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, was to demonstrate contribution of each
agent in the TG-1101 (ublituximab) + TGR-1202 (umbralisib) or U2
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. Inaddition, 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 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
matureB-lymphocytes. TG Therapeutics is also developing TGR-1202
(umbralisib), 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, or the
combination of which is referred to as “U2”, are in
Phase 3 clinical development for patients with hematologic
malignancies, with TG-1101 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
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
complete the UNITY-CLL trial or deliver data on schedule as
planned; the risk that the combination of TG-1101 and TGR-1202,
referred to as TG-1303 or “U2”, and being studied in
the UNITY clinical trials, will not prove to be a safe and
efficacious combination treatment option for any indication; the
risk that UNITY-CLL does not demonstrate an ORR advantage or that
even if an ORR advantage is shown that the results do not support
accelerated approval; the risk that Unity-CLL will not demonstrate
a PFS advantage; the risk that safety issues or trends will be
observed in the UNITY-CLL study or any other on-going studies that
prevent approval of either TG-1101 and/or TGR-1202; the risk that
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 a filing
based on UNITY-CLL, GENUINE or any other registration-direct trials
cannot be madeon schedule as targeted or at all; the risk that the
filing timelines for GENUINE and UNITY-CLL do not overlap or do not
occur at all; the risk that early clinical trial results, that may
have influenced our decision to proceed with additional clinical
trials, will not be reproduced in the final data presented; the
risk that the final data will not support regulatory approval. 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
TG Therapeutics, Inc. Recaps Clinical Data Presentations at the
Upcoming 7th Joint ECTRIMS
– ACTRIMS Meeting
B-cell depletion data and MRI data at 24 weeks (6 months) to be
presented
Abstract data shows complete (100%) elimination of T1 Gd-enhancing
lesions at week 24
New
York, NY, (October 16, 2017)
TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that clinical
abstracts featuring data from the Phase 2 multicenter trial of
TG-1101 (ublituximab), the Company’s novel glycoengineered
anti-CD20 monoclonal antibody, in relapsing forms of Multiple
Sclerosis (RMS) have been selected for presentation at the
upcoming 7th
Joint ECTRIMS – ACTRIMS meeting,
to be held next week, October 25 – 28, 2017, at the Le Palais
de Congrès de Paris, in Paris, France. Abstracts are now
available online and can be accessed on the ECTRIMS meeting website
at www.ectrims-congress.eu.
Details of the poster presentations are outlined
below.
Abstract Highlights:
●
TG-1101 completely eliminated all (100%) of T1 Gd-enhancing lesions
at week 24 (n=16)
●
At week 4, median 99% B-cell depletion was observed and maintained
at week 24 (6 months) (n=24)
●
TG-1101 was well tolerated with no study drug related SAE’s
reported and accelerated infusions times as short as 1 hour for the
450mg Phase 3 dose and regimen did not increase the rate of
Infusion Related Reactions (IRR) (n=24)
Michael S. Weiss, the Company’s Executive Chairman and Chief
Executive Officer stated, “We are excited to release the
first clinical MRI data of TG-1101 in patients with RMS as we
believe the abstract data presents an extremely compelling case for
the use of TG-1101 in the treatment of patients with MS. While
still early, the data thus far is setting the stage for a
best-in-class profile for TG-1101 in treating MS. We are looking
forward to presenting the full data on the first three cohorts
(n=24) through 24 weeks (6 months) of treatment at the
ECTRIMS-ACTRIMS meeting next week.” Mr. Weiss continued,
“We will continue to update these data at multiple
conferences over the next year as we treat and follow the full 48
patients (from the 6 cohorts) for up to 1 year. With our Phase 3
program now underway pursuant to a Special Protocol Assessment
(SPA), we believe MS represents the next level of growth for the
Company.”
Poster Presentation Details:
●
Title:
Patient characteristics, safety, and preliminary results of a
placebo controlled, phase 2a multicenter study of ublituximab
(UTX), a novel glycoengineered anti-CD20 monoclonal antibody (mAb),
in patients with relapsing forms of multiple sclerosis
o
Presentation Date & Time: Thursday,
October 26th, 2017; 15:30-17:00
CEST
o
Session
Title: Poster Session 1
o
Presenter:
Edward Fox, MD, PhD, Central Texas Neurology Consultants, Round
Rock, Texas
●
Title:
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 Gd-enhancing lesions decrease
o
Presentation Date & Time: Thursday, October
26th,
2017; 15:30-17:00 CEST
o
Session
Title: Poster Session 1
o
Presenter:
Matilde Inglese, MD, PhD, Icahn School of Medicine at Mount Sinai,
New York, NY
●
Placebo
controlled, phase 2a multicenter study of ublituximab (UTX), a
novel glycoengineered anti-CD20 monoclonal antibody (mAb), in
patients with relapsing forms of multiple sclerosis (RMS): 6 months
analysis of B cell subsets
o
Presentation Date & Time: Friday,
October 27th, 2017; 15:30-17:00
CEST
o
Session
Title: Poster Session 2
o
Presenter:
Amy E. Lovett-Racke, PhD, The Ohio State University, Columbus,
OH
These data presentations support the recently announced
international Phase 3 program evaluating TG-1101 (ublituximab) for
the treatment of relapsing form 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 will be led by
Lawrence Steinman, MD, of Stanford University.
A copy of the above abstracts can be found on the ECTRIMS meeting
website at www.ectrims-congress.eu.
Following each poster presentation, the data presented will be
available on the Publications page, located within the Pipeline
section, of the Company’s website at
www.tgtherapeutics.com.
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 (umbralisib), 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, or the combination of which is referred to as "U2", are
in Phase 3 clinical development for patients with hematologic
malignancies, with TG-1101 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 the abstract submission will not be reproduced in the
full data presentation;the risk that the clinical results from the
MS Phase 3 program, will not be 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
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.
TGTX -
G
Jenna
Bosco
Vice President -
Investor Relations
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email: ir@tgtxinc.com