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): June 15, 2018
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.)
|
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:
☐
Written
communications pursuant to Rule 425 under the Securities
Act.
☐
Soliciting material
pursuant to Rule 14a-12 under the Exchange Act.
☐
Pre-commencement
communications pursuant to Rule 14d-2b under the Exchange
Act.
☐
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange
Act.
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 June 15, 2018, TG Therapeutics, Inc. (the
“Company”) issued a press release announcing the
presentation of an integrated analysis of long term safety data of
umbralisib (TGR-1202), the Company’s PI3K delta inhibitor, as
well as the first preclinical data presentation of TG-1701, the
Company’s orally available and covalently-bound BTK
inhibitor, at the 23rd Congress of European Hematology Association
(EHA). On June 15, 2018, the Company also announced updated
clinical data from its ongoing Phase I study evaluating umbralisib
(TGR-1202), the Company's PI3K delta inhibitor in combination with
ruxolitinib, the JAK 1/2 inhibitor, in ruxolitinib experienced
patients with myelofibrosis (MF), at the 23rd Congress of EHA.
Copies of the press releases are being filed as Exhibits 99.1 and
Exhibits 99.2 and incorporated in this Item by
reference.
Item 9.01 Financial Statements And
Exhibits.
(d)
Exhibits.
99.1 Press Release, dated June 15,
2018.
99.2 Press Release, dated June 15,
2018.
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: June 15,
2018
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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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Exhibit
99.1
TG Therapeutics, Inc. Announces Clinical and Preclinical Data
Presentations at the 23rd Congress of the
European Hematology Association
NEW
YORK, NY (June 15, 2018) - TG Therapeutics, Inc. (NASDAQ: TGTX),
today announced the presentation of an integrated analysis of long
term safety data of umbralisib (TGR-1202), the Company’s PI3K
delta inhibitor, either dosed as a single agent and in combination,
in patients with relapsed or refractory lymphoid malignancies, as
well as the first preclinical data presentation of TG-1701, the
Company’s orally available and covalently-bound BTK
inhibitor. Data from these trials are being presented today during
the 23rd
Congress of the European Hematology Association (EHA).
Michael
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, “We are extremely pleased to present updated
data from our integrated safety analyses of umbralisib. There is a
generally held belief that severe toxicities are more common
following 6 months of exposure on a PI3K delta inhibitor. While
this has held true for first generation delta inhibitors, we are
pleased to present data from 177 patients on daily umbralisib for
more than 6 months, ranging upwards of 5+ years, and believe the
long-term follow-up data demonstrates that umbralisib has a
differentiated safety profile, uniquely distinct from prior
generation PI3K delta inhibitors.” Mr. Weiss continued,
“The differentiated safety profile of umbralisib is critical
as we think about potential triple and quad combination strategies,
especially in combination with our novel, proprietary BTK
inhibitor, TG-1701, for which we also presented some exciting
pre-clinical data. The kinase profile of TG-1701 looks quite
competitive with the most specific BTK inhibitors and more
selective than ibrutinib. We look forward to seeing more data on
TG-1701 and expect to open a TG sponsored Phase 1/2 trial later
this year.”
Highlights
from today’s presentations include the
following:
Poster
Presentation: Long term integrated safety analysis of
umbralisib (TGR-1202), a PI3K delta/CK1-epsilon inhibitor with a
differentiated safety profile in patients with relapsed/refractory
lymphoid malignancies
This presentation builds on a prior integrated analysis of 347
patients with relapsed or refractory lymphoid malignancies
presented last year. The presentation includes data that were
pooled from 4 completed or ongoing Phase 1 or 2 studies containing
umbralisib, focusing on 177 patients who have been on daily
umbralisib for a minimum of 6 months. Patients were heavily
pretreated, with 45% of patients having seen 3 or more prior lines
of therapy.
Highlights from this poster include:
●
Umbralisib
continues to exhibit a differentiated safety profile compared to
prior generation PI3K delta inhibitors
●
177
patients have been treated with daily umbralisib for 6+ months,
with a median duration of exposure of 1.3 years, and 33% patients
on drug 2+ years and the longest patients on daily umbralisib for
over 5 years
o
Serious
adverse events occurring in >1% of patients were limited to
pneumonia (3%), diarrhea (2%), and cellulitis (2%)
o
Only
2% of patients discontinued as a result of diarrhea/colitis after
being on umbralisib for more than 6 months
o
Discontinuations
due to other adverse events (AEs) of interest for prior generation
PI3K inhibitors were also rare
Poster Presentation: TG-1701 is a novel, orally
available, and covalently-bound BTK inhibitor
●
TG-1701, a novel,
specific and covalent BTK inhibitor, is more selective than
ibrutinib toward a set of kinases
●
BTK occupancy
assays in vitro and in vivo suggest that 100% occupancy can be
reached using low doses of TG-1701 in human dose escalation
clinical trial
●
In pre-clinical
experiments, TG-1701 inhibited the phosphorylation of BTK and other
kinases downstream of the BCR pathway.
●
In cellular and
animal models of b-cell malignancies, TG-1701 demonstrated similar
antitumor efficacy to ibrutinib and acalabrutinib
PRESENTATION DETAILS
The
above referenced presentations are now available on the
Publications page, located within the Pipeline section, of the
Company’s website at www.tgtherapeutics.com/publications.cfm.
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. Ublituximab (TG-1101) 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 umbralisib (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 ublituximab and umbralisib, or the
combination of which is referred to as "U2", are in Phase 3
clinical development for patients with hematologic malignancies,
with ublituximab 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 or in the
abstracts mentioned 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. Among the factors that
could cause our actual results to differ materially are the
following: our ability to successfully and cost-effectively
complete preclinical and clinical trials; the risk that
early clinical trial results (both safety and efficacy), that may
have supported the acceptance of our data for presentation or
influenced our decision to proceed with additional clinical trials,
will not be reproduced in future studies or in the final
presentations; the risk that
the differentiated tolerability profile for umbralisib observed
will not be reproduced in full presentations or later larger
studies; the risk that umbralisib is not a differentiated PI3K
delta inhibitor; the risk that the combination of ublituximab
(TG-1101) and umbralisib (TGR-1202), referred to as U2, and being
studied in the UNITY clinical trials and other studies, will not
prove to be safe and efficacious for any indication or will not
prove to be a safe and efficacious backbone for future triple or
quad therapies; the risk that we will not open a TG sponsored Phase
1/2 trial of TG-1701; the risk that we will not study the triple
combination of ublituximab, umbralisib and TG-1701 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.
CONTACT:
Jenna
Bosco
SVP,
Corporate Communications
TG
Therapeutics, Inc.
Telephone:
212.554.4351
Email:
ir@tgtxinc.com
Exhibit 99.2
TG Therapeutics, Inc. Announces Oral Presentation of Umbralisib
plus Ruxolitinib in Patients with Myelofibrosis at the
23rd
Congress of the European Hematology Association
Data demonstrates that the addition of umbralisib to ruxolitinib
can induce responses in patients with sub-optimal response to
ruxolitinib single agent
NEW
YORK, NY (June 15, 2018) - TG Therapeutics, Inc. (NASDAQ: TGTX),
today announced updated clinical data from its ongoing Phase I
study evaluating umbralisib (TGR-1202), the Company’s PI3K
delta inhibitor in combination with ruxolitinib, the JAK 1/2
inhibitor, in ruxolitinib experienced patients with myelofibrosis
(MF). Data from this trial are being presented this morning during
the 23rd
Congress of the European Hematology Association (EHA).
Michael
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, “The data presented in patients with
myelofibrosis represents yet another unique opportunity for
umbralisib, in this case providing a treatment option to patients
who are not achieving an optimal response to ruxolitinib
monotherapy. This type of study highlights the unique breadth of
activity of PI3K delta inhibition across hematological malignancies
and underscores the importance of umbralisib’s safety
profile, that permits a wide range of combinations.” Mr.
Weiss continued, “We look forward to evaluating this
combination further, potentially in a randomized pivotal
setting.”
Highlights
from this morning’s presentation include the
following:
Oral Presentation:
Resurrecting response to ruxolitinib: a phase I study testing the
combination of ruxolitinib and the PI3Kdelta inhibitor umbralisib
in ruxolitinib-experienced myelofibrosis (Abstract Number
S133)
This
oral presentation includes data from patients with myelofibrosis
treated with the combination of ruxolitinib, the JAK1/2 inhibitor
and umbralisib (TGR-1202). Importantly, per protocol, all enrolled
patients were on a stable dose of ruxolitinib monotherapy and had
achieved their best response to ruxolitinib prior to enrolling to
receive umbralisib. Presentation highlights included:
●
The combination of
umbralisib + ruxolitinib was well-tolerated with limited Grade 3/4
adverse events;
o
Dose-limiting
toxicities of asymptomatic amylase/lipase elevations were observed
of unclear clinical consequence;
●
Increases in
hemoglobin, improvements in spleen size, and reduction in symptoms
meeting IWG-MRT criteria for clinical improvement were seen in 13
(57%) ruxolitinib-experienced myelofibrosis patients;
●
Importantly, 2
patients (9%) achieved a durable complete remission after
progressing on ruxolitinib;
●
The addition of
umbralisib to ruxolitinib demonstrates the ability to augment or
resurrect a response in myelofibrosis patients who had suboptimal
or lost response to ruxolitinib alone.
PRESENTATION DETAILS
The
above referenced presentation is now available on the Publications
page, located within the Pipeline section, of the Company’s
website at www.tgtherapeutics.com/publications.cfm.
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. Ublituximab (TG-1101) 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
umbralisib (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 ublituximab
and umbralisib, or the combination of which is referred to as "U2",
are in Phase 3 clinical development for patients with hematologic
malignancies, with ublituximab 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 or in the
abstracts mentioned 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. Among the factors that
could cause our actual results to differ materially are the
following: our ability to successfully and cost-effectively
complete preclinical and clinical trials; the risk that
early clinical trial results (both safety and efficacy), that may
have supported the acceptance of our data for presentation or
influenced our decision to proceed with additional clinical trials,
will not be reproduced in future studies or in the final
presentations; the risk that the differentiated tolerability
profile for umbralisib observed will not be reproduced in full
presentations or later larger studies the risk that we will not
evaluate the combination of ruxolitinib and umbralisib in
myelofibrosis or any other indication; 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.
CONTACT:
Jenna
Bosco
SVP,
Corporate Communications
TG
Therapeutics, Inc.
Telephone:
212.554.4351
Email:
ir@tgtxinc.com