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 11, 2017
TG Therapeutics, Inc.
(Exact Name of
Registrant as Specified in Charter)
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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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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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 11, 2017, TG Therapeutics, Inc. (the
“Company”) issued a press release announcing clinical
and preclinical data presented involving the Company’s lead
compounds, TGR-1202 (umbralisib), the Company's once-daily PI3K
delta inhibitor, and TG-1101 (ublituximab), the Company's novel
glycoengineered anti-CD20 monoclonal antibody, at the
59th
American Society of Hematology (ASH) annual meeting, being held at
the Georgia World Congress Center in Atlanta, Georgia. 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 December
11, 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:
December 11,
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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-3-
Blueprint
TG Therapeutics, Inc. Announces Preclinical & Clinical Data
Presentations at the 59h American Society of
Hematology Annual Meeting
Clinical presentations continue to underscore safety profile of
TGR-1202 as monotherapy and in combination, including in long-term
follow-up
Preclinical advances may offer rationale for the differentiated
activity and safety of TGR-1202
ATLANTA,
GA (December11, 2017) - TG Therapeutics, Inc. (NASDAQ:TGTX),
announces the presentation of six posters highlighting preclinical
and clinical data sets for TGR-1202 (umbralisib), the
Company’s once-daily PI3K delta inhibitor, and TG-1101
(ublituximab), the Company's novel glycoengineered anti-CD20
monoclonal antibody, at the 59th American
Society of Hematology (ASH) annual meeting, currently being
held at the Georgia World Congress Center in Atlanta,
Georgia.
Michael
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, "We are very pleased by the data presented
yesterday and today during the ASH annual meeting. The preclinical
data help us to better understand the difference between TGR-1202
and other agents in the class and offers a more complete rationale
for the differentiated safety profile seen in the clinic. With the
updated and expanded integrated safety analysis of TGR-1202 alone
and in combination with other agents, we believe we have provided
the long-term follow-up sufficient to allay any lingering safety
concerns related to TGR-1202 caused by the toxicity profile of
first generation PI3K delta inhibitors.” Mr. Weiss continued,
“In 2018, with registration-directed data expected in CLL and
NHL, our focus will turn to showcasing the efficacy of TGR-1202 and
our proprietary combination of TG-1101 plus TGR-1202, our U2
combination, ideally leading to NDA/BLA filings in CLL and
NHL.”
The
following summarizes the highlights from each poster presented at
the ASH 2017 meeting.
Clinical Data Presentations:
An Integrated Safety Analysis of the Next Generation PI3K Delta
Inhibitor Umbralisib (TGR-1202) in Patients with
Relapsed/Refractory Lymphoid Malignancies
This
presentation includes data that were pooled from 5 completed or
ongoing Phase 1 or 2 studies containing TGR-1202, including a total
of 347 patients with relapsed or refractory hematologic
malignancies. Patients were heavily pretreated, with 50% of
patients having seen 3 or more prior lines of therapy.
Highlights
from this poster include:
●
347 patients have
been treated with TGR-1202 across the 5 studies in this pooled
analysis, with median duration of exposure of 6.5 months, and 176
patients on drug for 6+ months, 104 patients for 12+ months, with
the longest patients on daily TGR-1202 for 4+ years
●
In longer follow-up
and in an expanded patient population, TGR-1202 exhibits a
differentiated safety profile compared to prior generation PI3K
delta inhibitors
●
Discontinuations
due to adverse events (AEs) were rare at under 10% for all
studies
●
Grade 3/4 AEs
commonly associated with PI3K delta inhibitors have been rare, with
pneumonitis (< 0.5%), transaminitis (~2%) and colitis (< 1%),
the latter occurring with no apparent association to time on
therapy
●
Improved
tolerability with few discontinuations due to AEs has allowed
patients to remain on continuous dosing to achieve and sustain
promisingly high rates of response:
o
85% Overall
Response Rate (ORR) for single agent TGR-1202 in
relapsed/refractory Chronic Lymphocytic Leukemia (CLL)
o
53% ORR for single
agent TGR-1202 in relapsed/refractory Follicular Lymphoma
(FL)
KI Intolerance Study: A Phase 2 Study to Assess the Safety and
Efficacy of Umbralisib (TGR-1202) In Patients with Chronic
Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or
PI3K-delta Inhibitor Therapy (Abstract Number 4314)
This
poster presentation includes data from patients with CLL who are
intolerant to prior BTK or PI3K delta inhibitor therapy who were
then treated with single agent TGR-1202. To be eligible for
the study patients had to have received prior treatment with a BTK
inhibitor (ibrutinib, acalabrutinib) or a PI3K delta inhibitor
(idelalisib, duvelisib) and discontinued therapy due to intolerance
within 12 months of starting treatment on this study. Thirty-three
patients were evaluable for safety (30 patients with ibrutinib
intolerance, and 3 patients with idelalisib intolerance) of which
32 were evaluable for efficacy (1 patient had a confirmed
Richter’s Transformation (RT) at enrollment which did not
meet eligibility criteria). TGR-1202 appears to demonstrate a
favorable safety profile in patients intolerant to prior ibrutinib
or idelalisib, with only 2 patients (6%) discontinuing due to an
adverse event, neither of which was a recurrent AE from prior TKI
therapy.
Highlights
from this poster include:
●
94% (30 of 32) of
patients remain progression-free
●
Median time on
study at the data cut off was approximately 6 months with the
majority of patients continuing on study and follow-up
ongoing
●
No patient
discontinued TGR-1202 due to a recurrent AE which led to
discontinuation from their prior kinase inhibitor
Phase I/II Study of Pembrolizumab in Combination with Ublituximab
(TG-1101) and Umbralisib (TGR-1202) in Patients with
Relapsed/Refractory CLL (Abstract Number 3010)
This
presentation includes data from patients with relapsed or
refractory Chronic Lymphocytic Leukemia (CLL) or Richter’s
Transformation (RT) treated with the triple combination of TG-1101,
TGR-1202, and pembrolizumab. Eleven patients were evaluable for
safety (9 CLL patients and 2 RT patients) and 10 were evaluable for
efficacy (9 CLL and 1 RT), with one patient too early to
evaluate.
Highlights
from this poster include:
●
One AE of increased
LFTs was observed which met criteria for DLT; patient was
re-challenged and remains on study treatment with TGR-1202
maintenance now 15+ months
●
78% (7 of 9) ORR in
patients with relapsed/refractory CLL
●
75% (3 of 4) ORR in
BTK refractory CLL patients
●
Responses have been
durable with the first patient progression-free for 24+
months
Preclinical Data Presentations:
Differential Regulation of T Cells By PI3K Delta Inhibitors in a
CLL Murine Model (Abstract Number: 3009)
This
poster presentation included preclinical data describing the
differential regulation of human T cells by TGR-1202 in a
preclinical CLL murine model.
Highlights
from this poster include:
●
TGR-1202 oral
treatment induced less incidence of toxicity in CLL mice compared
to other PI3K delta inhibitors
●
TGR-1202 relatively
preserved Treg quantity and function in a dose dependent manner
compared to other PI3K delta inhibitors in normal and murine CLL T
cells
●
Inhibition of
casein-kinase 1 epsilon (CK1e) by TGR-1202 may explain the relative
preservation of Treg cells in these in-vivo models
Umbralisib/TGR-1202 As a Novel Dual PI3K/CK1 Inhibitor Has a Unique
Therapeutic Role in Silencing Oncogenes in Aggressive Lymphomas
(Abstract Number 2809)
This
poster presentation expanded on existing preclinical data
demonstrating that TGR-1202 is synergistic with carfilzomib in
certain aggressive lymphoma cell lines.
Highlights
from this poster include:
●
TGR-1202
is highly synergistic with the proteasome inhibitor carfilzomib in
cell line models of double hit lymphoma and mantle cell
lymphoma
●
Based
on this preclinical work, a Phase 1 clinical study to evaluate the
safety and efficacy of TGR-1202 in combination with carfilzomib is
currently enrolling patients
PI3K Delta Inhibitors Induce Primary Monocyte Cytotoxicity but Do
Not Alter Monocyte Differentiation (Abstract Number
4284)
This
poster presentation included preclinical data exploring the effect
of PI3K delta inhibitors on monocyte activity.
Highlights
from this poster include:
●
The clinical
benefit and initial lymphocytosis seen with PI3K delta inhibitors
in CLL may be related in part to
direct effects on monocyte derived cells
●
Idelalisib
and TGR-1202 differed in the extent of monocyte cytotoxicity
induced and inhibition of pAKT
●
The direct effects of PI3K delta inhibitors on
monocytes suggests these drugs may have efficacy beyond B-cell
malignancies, including in monocytic neoplasms or other
malignancies with monocyte derived cells in the tumor
microenvironment
The
above referenced presentations, are available on the Publications
page 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
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 early
preclinical and 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 future data presentations; the risk that
preclinical findings may not translate into predicted potential
clinical outcomes or be reproduced in future experiments; 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 double
combination or backbone for triple therapies;the risk that early
clinical data from triple combination studies will not be
reproduced in additional patients or future clinical trials; the
risk that TGR-1202 will not maintain its differentiated safety
profile as patients continue to be treated on drug for longer
durations and more patients are enrolled; the risk that any interim
analyses from ongoing clinical trials will not produce the desired
or predicted result in the final analysis; the risk that the
company will not be able to deliver data or updates on schedule as
planned; the risk projected BLA/NDA filings cannot be made on
schedule as targeted or at all. 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