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): December 3, 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.)
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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:
☐
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 December 3,
2018, TG Therapeutics, Inc. (the “Company”) issued a
press release announcing updated clinical data from its Phase I/II
trial of ublituximab (TG-1101), the Company’s novel
glycoengineered anti-CD20 monoclonal antibody in combination with
umbralisib (TGR-1202), the Company’s oral, next generation
PI3K delta inhibitor, and pembrolizumab, in patients with
relapsed/refractory Chronic Lymphocytic Leukemia (CLL) and
Richter’s Transformation (RT) presented during the
60th
American Society of Hematology (ASH) Annual Meeting and Exposition.
On December 4, 2018 the Company also announced updated clinical
data from its Phase I/Ib trial of ublituximab in combination with
umbralisib, and bendamustine, in patients with Diffuse Large B-cell
Lymphoma (DLBCL) and Follicular Lymphoma (FL) also presented during
the 60th
Annual ASH Meeting. Copies of the press releases are being filed as
Exhibit 99.1 and Exhibit 99.2 and incorporated in this Item by
reference.
Item 9.01 Financial Statements And
Exhibits.
(d)
Exhibits.
99.1 Press Release, dated December 3,
2018.
99.2 Press Release, dated December 4,
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: December 4,
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 Oral Presentation of Follow-Up Data
from the Triple Combination of Ublituximab, Umbralisib, and
Pembrolizumab in Patients with Relapsed/Refractory CLL and
Richter’s Transformation at 60th American Society of
Hematology Annual Meeting and Exposition
NEW
YORK, NY (December 3, 2018) - TG
Therapeutics, Inc. (NASDAQ: TGTX), today announced updated clinical
data from its Phase I/II trial of ublituximab (TG-1101), the
Company’s novel glycoengineered anti-CD20 monoclonal antibody
in combination with umbralisib (TGR-1202), the Company’s
oral, next generation PI3K delta inhibitor, and pembrolizumab, in
patients with relapsed/refractory Chronic Lymphocytic Leukemia
(CLL) and Richter’s Transformation (RT). Data from this trial
were presented yesterday during an oral session at the
60th
American Society of Hematology (ASH)
Annual Meeting and Exposition.
Michael
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, “We were excited to share the data presented
from the combination of U2 plus pembrolizumab. Due to potentially
overlapping immune-mediated toxicity, this is the first trial where
a PI3K delta inhibitor has been combined with a PD-1/PD-L1
inhibitor, again highlighting the unique combinability of the U2
regimen. In addition to demonstrating that these drugs could be
safely combined, we were encouraged to see favorable response rates
in both RT and BTK refractory CLL patients, a subset of patients
that are historically challenging to treat.” Mr. Weiss
continued, “Our proprietary anti-PD-L1, TG-1501, has now
completed Phase 1 dose escalation, and we believe the data
presented today set the stage for the commencement of the
combination of U2 plus TG-1501, in the coming
months.”
Below
summarizes the oral presentation.
Phase I/II Study of Umbralisib (TGR-1202) in Combination with
Ublituximab (TG-1101) and Pembrolizumab in Patients with
Relapsed/Refractory CLL and Richter’s Transformation
(Publication Number: 297)
This
oral presentation includes data from patients with relapsed or
refractory CLL or Richter’s Transformation treated with the
triple combination of ublituximab, umbralisib, and pembrolizumab.
Fifteen patients were evaluable for safety (10 CLL patients and 5
RT patients) and 14 were evaluable for efficacy (10 CLL and 4 RT),
with one RT patient too early to evaluate. Data highlights
include:
●
The triple
combination was well tolerated, with immune mediated toxicities not
appearing above what would be expected with either umbralisib or
pembrolizumab alone
●
90% (9 of 10)
Overall Response Rate (ORR) in patients with relapsed/refractory
CLL, including one Complete Response (CR)
●
80% (4 of 5) ORR in
BTK refractory CLL patients, of which 3 of 4 BTK refractory CLL
responders achieved their response to U2 alone prior to
introduction of pembrolizumab
●
50% (2 of 4) ORR in
RT, with both responses being a CR
●
Responses have been
durable, and a median progression-free survival has not yet been
reached
●
The first patient
treated remains progression-free for 36+ months, having now been
off therapy for more than 24 months
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, TG-1501, as well as its
covalently-bound Bruton Tyrosine Kinase (BTK) inhibitor, TG-1701,
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
preclinical and clinical trials; the risk that the highlighted
early clinical trial results, 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
combination of ublituximab (TG-1101) and umbralisib (TGR-1202),
referred to as U2 and being studied in the UNITY clinical trials,
will not prove to be a safe and efficacious combination, or
backbone for triple therapy combinations; the risk that TG-1501
will not demonstrate acceptable safety or efficacy as either a
single agent or in combination with any other agents; the risk that
a trial evaluating the combination of U2 plus TG-1501 will not
commence. 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
Senior
Vice President,
Corporate
Communications
TG
Therapeutics, Inc.
Telephone:
212.554.4351
Email:
ir@tgtxinc.com
Exhibit 99.2
TG Therapeutics, Inc.
Announces Follow-Up Data from the
Triple Combination of Ublituximab, Umbralisib, and Bendamustine in
Patients with DLBCL and FL at 60th
American Society of Hematology
Annual Meeting and Exposition
NEW YORK, December 4, 2018 -- TG Therapeutics, Inc. (NASDAQ: TGTX), today
announced updated clinical data from its Phase I/Ib trial of
ublituximab (TG-1101), the Company’s novel glycoengineered
anti-CD20 monoclonal antibody in combination with umbralisib
(TGR-1202), the Company’s oral, next generation PI3K delta
inhibitor, and bendamustine, in patients with Diffuse Large B-cell
Lymphoma (DLBCL) and Follicular Lymphoma (FL). Data from this trial
was presented yesterday evening during a poster session at the
60th
American Society of Hematology (ASH)
Annual Meeting and Exposition.
Michael
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer stated, “The data presented yesterday further
supports our belief that our proprietary U2 combination is an ideal
backbone regimen on which to build novel multi-drug combinations.
The triple therapy of U2 plus bendamustine is highly active and
well tolerated in advanced patients, resulting in durable responses
with some patients on study 36+ months.” Mr. Weiss continued,
“We are looking forward to an exciting 2019, with pivotal
data expected from the ongoing UNITY-NHL registration directed
program in the first half of the year.”
Below summarizes the data from the poster
presentation.
Combination of Umbralisib, Ublituximab, and Bendamustine is Safe
and Highly Active in Patients with Advanced DLBCL and Follicular
Lymphoma (Abstract 4197)
This
poster presentation includes data from patients with relapsed or
refractory DLBCL or FL treated with the triple combination of
umbralisib, ublituximab and bendamustine. Thirty-nine patients were
evaluable for safety of which 38 were evaluable for efficacy (one
patient discontinued due to a treatment-related adverse event (AE),
neutropenia, prior to first efficacy assessment). Twenty-two
patients (56%) were refractory to prior treatment. Overall, the
triple combination was well tolerated and highly active in patients
with advanced indolent and aggressive NHL, including those not
eligible for HD/SCT or CD19 CART therapy.
Efficacy highlights from this poster include:
●
85%
(11 of 13) ORR, including a 54% CR rate, observed in patients with
relapsed or refractory FL
●
48%
(12 of 25) ORR, including a 36% CR rate, observed in patients with
relapsed or refractory DLBCL
PRESENTATION DETAILS:
The
above referenced presentation is 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, TG-1501, as well as its
covalently-bound Bruton Tyrosine Kinase (BTK) inhibitor, TG-1701,
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
preclinical and clinical trials; the risk that the highlighted
early clinical trial results, including the safety and efficacy results seen
with the combination of ublituximab (TG-1101), umbralisib
(TGR-1202) plus bendamustine 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
combination of ublituximab and umbralisib, referred to as U2 and
being studied in the UNITY clinical trials, will not prove to be a
safe and efficacious combination, or backbone for triple therapy
combinations; the risk that data from the UNITY-NHL trial will not
be delivered on time or as planned. 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
Senior
Vice President,
Corporate
Communications
TG
Therapeutics, Inc.
Telephone:
212.554.4351
Email:
ir@tgtxinc.com