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 5, 2016
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 December 5,
2016, TG Therapeutics, Inc. issued press releases announcing
certain data regarding preclinical and clinical studies of TGR-1202
at the 58th American Society of Hematology (ASH) annual meeting in
San Diego, CA. Copies of the press releases are being filed as
Exhibits 99.1 and 99.2 and incorporated in this Item by
reference.
Item 9.01 Financial Statements And
Exhibits.
(d)
Exhibits.
99.1 Press
Release, dated December 5, 2016.
99.2 Press
Release, dated December 5, 2016
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 5,
2016
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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 December 5, 2016
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99.2
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Press Release,
dated December 5, 2016
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Exhibit 99.1
TG
Therapeutics, Inc. Announces Preclinical Data Presentations for
TGR-1202 at the 58th American Society of
Hematology Annual Meeting
Preclinical work may offer rationale for the differentiated
activity and safety effects of TGR-1202
SAN
DIEGO, CA (December 5, 2016) - TG Therapeutics, Inc. (NASDAQ:TGTX),
announced the presentation yesterday of two preclinical data sets,
one oral presentation and one poster presentation, for TGR-1202,
the Company’s once-daily PI3K delta inhibitor, at the
58th
American Society of Hematology (ASH) annual meeting in San Diego,
California.
Michael
S. Weiss, the Company's Executive Chairman and Interim Chief
Executive Officer, stated, "We want to thank the teams at Columbia
and Moffitt for their extensive laboratory work on TGR-1202 to
better understand the mechanism of action and impact on the immune
system. The preclinical data they have generated helps to better
explain and perhaps offer a rationale for the differentiated safety
profile seen with TGR-1202 as compared to earlier generation PI3K
delta inhibitors. We believe these preclinical findings along with
the robust safety and efficacy data we have observed in the clinic,
support our belief that TGR-1202 is a differentiated best in class
PI3K delta inhibitor. We look forward to continuing our research
collaborations with Columbia and Moffitt and to presenting updated
safety and efficacy data for TGR-1202 to further confirm its unique
profile.”
“Dr. Deng's
presentation today has really begun to shed some long-needed light
on the important differences among the PI3K delta inhibitors. His
work has identified that a novel kinase important in the PI3K
pathway, CK-1epsilon, is uniquely inhibited by TGR-1202, which may
explain the drug’s effects on c-Myc. These chemical
differences may also help to explain the important immunologic
differences in the safety profiles of these agents,” stated
Dr. Owen A. O’Connor, Professor
of Medicine and Experimental Therapeutics, Director Lymphoid
Malignancies at Columbia Presbyterian Medical
Center.
The
following summarizes the oral presentation and poster presentation
which occurred yesterday:
Oral Presentation:
Silencing c-Myc Translation as a Therapeutic Strategy through
Targeting PI3K Delta and CK1 Epsilon in Hematological Malignancies
(Abstract Number 291)
This
oral presentation includes data from the manuscript titled,
“Silencing c-Myc Translation as a Therapeutic Strategy
through Targeting PI3K Delta and CK1 Epsilon in Hematological
Malignancies,” which was recently published in Blood, the Journal of the American
Society of Hematology. The presentation was delivered by Changchung
Deng, MD, PhD of Columbia Presbyterian Medical Center and included
the following highlights:
●
TGR-1202 and
carfilzomib, but not combinations of other drugs in the same
classes, synergistically inhibit c-Myc translation and c-Myc
dependent gene transcription, by potently inhibiting
phosphorylation of 4E-BP1;
●
TGR-1202 and
carfilzomib synergistically induce apoptosis in lymphoma cells
through targeting c-Myc, whereas the other combinations did
not;
●
TGR-1202, but not
idelalisib or duvelisib, was found to uniquely inhibit casein kinase-1 (CK1) epsilon;
and
●
Based on this
extensive preclinical work, the Company recently announced the
launch of a Phase 1/2 study to evaluate the safety and efficacy of
TGR-1202 in combination with carfilzomib, in patients with relapsed
or refractory lymphoma.
Poster
Presentation: Modulation of T Cell Compartment in a
Preclinical CLL Murine Model By a Selective PI3K Delta Inhibitor,
TGR-1202 (Abstract Number 3236)
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:
●
Both TGR-1202 and
duvelisib oral administration demonstrated
comparable efficacy by reducing CLL burden over time in leukemic
mice;
●
TGR-1202 and
duvelisib both targeted the T cell population in vivo, however:
●
TGR-1202 relatively
maintained the number of Tregs and Th17 cells and expression of
functional markers on Tregs compared to duvelisib treatment
in vivo and ex vivo; and
●
Duvelisib resulted
in greater disruption of Treg/Th17 ratio compared to TGR-1202
in vivo, which may have
implications for occurrence of autoimmune-like organ
toxicity.
PRESENTATION DETAILS:
Copies of the above referenced presentations are
available on the Company’s website at www.tgtherapeutics.com,
located on the Publications page.
TG THERAPEUTICS INVESTOR & ANALYST EVENT DETAILS:
TG Therapeutics will also host an investor and
analyst reception on Monday, December 5th,
2016 beginning at 8:00pm PT. The event will take place at the
Marriott Gaslamp, in San Diego, California, in the Presidio AB
Ballroom.
NOTE: This event
will be webcast live and will be available on the Events page,
located within the Investors & Media section of the
Company’s website at
www.tgtherapeutics.com, as well as
archived for future review. This event will also be broadcast via
conference call. In order to access the conference line,
please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the
U.S.), and reference Conference Title: TG Therapeutics 2016
Investor & Analyst Event.
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 recently entering 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
Some of
the statements included in this press release, particularly those
with respect to anticipating future clinical trials, the timing of
commencing or completing such trials and business prospects for
TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor
program, and the anti-PD-L1 and anti-GITR antibodies 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 for TG-1101, TGR-1202, the
IRAK4 inhibitor program, the BET inhibitor program, and the
anti-PD-L1 and anti-GITR antibodies; the risk that early
preclinical and clinical results that supported our decision to
move forward with TG-1101, TGR-1202, the IRAK4 inhibitor program,
the BET inhibitor program, and the anti-PD-L1 and anti-GITR
antibodies will not be reproduced in additional patients or in
future studies; the risk that trends observed which underlie
certain assumptions of future performance of TGR-1202 will not
continue, the risk that TGR-1202 will not produce satisfactory
safety and efficacy results to warrant further development
following the completion of the current Phase 1 study; the risk
that the combination of TG-1101 and TGR-1202, referred to as
TG-1303, will not prove to be a safe and efficacious backbone for
triple and quad combination therapies; the risk that the data (both
safety and efficacy) from future clinical trials will not coincide
with the data produced from prior preclinical and clinical trials;
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
CONTACT:
Jenna
Bosco
Vice President,
Investor Relations
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email:
ir@tgtxinc.com
Exhibit
99.2
TG
Therapeutics, Inc. Announces Oral Data Presentation for TGR-1202 in
Combination with Ibrutinib in Patients with Relapsed or Refractory
CLL or MCL at the 58th American Society of
Hematology Annual Meeting
Combination of TGR-1202 plus ibrutinib is well-tolerated with no
Grade 3/4 transaminitis, pneumonitis, diarrhea, or colitis
observed, with patients approaching two years on
therapy
88% ORR in CLL patients, including 1 CR, and 73% ORR in MCL
patients treated with the combination
SAN
DIEGO, CA (December 5, 2016) - TG Therapeutics, Inc. (NASDAQ:TGTX),
today announced the presentation of combination data from a Phase
1b study evaluating TGR-1202, the Company’s once-daily PI3K
delta inhibitor, in combination with ibrutinib, the oral
Bruton’s tyrosine kinase (BTK). This study is being run in
collaboration with the Blood Cancer Research Partnership (BCRP) and
Dana-Farber Cancer Institute (DFCI), Boston, MA. Data from this
trial were presented today by the Principal Investigator, Matthew
S. Davids, MD, of Dana-Farber Cancer Institute, during an oral
session at the 58th American Society of
Hematology (ASH) annual meeting in San Diego, CA.
Michael
S. Weiss, the Company’s Executive Chairman and Interim CEO
commenting on the data said, “We and our investigators
continue to be impressed with the ease of combining TGR-1202 with
other novel agents. Here Dr. Davids demonstrated that the double
blockade of the BCR pathway with dual oral once-daily inhibitors
can be performed safely and conveniently, and derives high response
rates in patients with both CLL and MCL. This all oral approach
offers a unique and highly active alternative for patients who do
not want to receive infused therapies but still want to advance
their treatment beyond single agent ibrutinib, which may offer
multiple benefits over single agent therapy. With one bone marrow
confirmed complete response (CR) and 5 additional deep responses
nearing radiographic CR out of the 17 evaluable CLL patients, we
and our investigators believe we are seeing activity beyond what
one might expect from either of these agents alone. We want to
thank Dr. Davids and his collaborators at DFCI and the Leukemia
& Lymphoma Society for providing support for this important
investigator driven research and we look forward to follow-up data
in the future from this study and data from our own triple therapy
of TG-1101 plus TGR-1202 plus ibrutinib, which we are targeting for
presentation next year.”
The
following summarizes the key highlights from this oral presentation
which occurred today:
Oral Presentation:
TGR-1202 in Combination with Ibrutinib in Patients with Relapsed or
Refractory CLL or MCL: Preliminary Results of a Multicenter Phase
I/Ib Study (Abstract Number 641)
This
oral presentation includes data from patients with relapsed or
refractory chronic lymphocytic leukemia (CLL) or mantle cell
lymphoma (MCL) treated with TGR-1202 in combination with Ibrutinib.
31 patients were evaluable for safety (18 CLL patients and 13 MCL
patients), of which 28 patients were available for efficacy (17 CLL
patients and 11 MCL patients.) CLL patients had a median of 1.5
prior lines of therapy (range 1-6), with 2 patients receiving prior
ibrutinib and 4 receiving prior PI3K inhibitors. MCL patients had a
median of 3 prior lines of therapy (range 2-5), also with 2
patients receiving prior ibrutinib.
Highlights
from this oral presentation include:
●
88%
(15 of 17) Overall Response Rate (ORR) (including Complete Response
(CR), Partial Response (PR), and Partial Response with
lymphocytosis (PR-L)) in patients with CLL, with 1 patient
achieving a bone marrow confirmed CR and 5 patients with a >80%
nodal reduction, nearing radiographic CR
●
1
year progression free survival (PFS) and overall survival (OS) for
CLL is 94% (n=17), with the longest patient on study approaching
two years
●
73%
(8/11) ORR in patients with MCL, with clinical benefit observed in
two additional patients
●
1
year PFS and OS for MCL is 37% and 52%, respectively
(n=11)
●
The
combination appears well tolerated across all patients with no
grade 3/4 transaminitis (liver toxicity), diarrhea, colitis or
pneumonitis observed
PRESENTATION DETAILS:
The above referenced presentation is available on
the Company’s website at www.tgtherapeutics.com,
located on the Publications page.
TG THERAPEUTICS INVESTOR & ANALYST EVENT DETAILS:
TG Therapeutics will also host an investor and
analyst reception on Monday, December 5th,
2016 beginning at 8:00pm PT. The event will take place at the
Marriott Gaslamp, in San Diego, California, in the Presidio AB
Ballroom.
NOTE: This event
will be webcast live and will be available on the Events page,
located within the Investors & Media section of the
Company’s website at
www.tgtherapeutics.com, as well as
archived for future review. This event will also be broadcast via
conference call. In order to access the conference line,
please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the
U.S.), and reference Conference Title: TG Therapeutics 2016
Investor & Analyst Event.
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 recently entering 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
Some of
the statements included in this press release, particularly those
with respect to anticipating future clinical trials, the timing of
commencing or completing such trials and business prospects for
TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor
program, and the anti-PD-L1 and anti-GITR antibodies 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 for TG-1101, TGR-1202, the
IRAK4 inhibitor program, the BET inhibitor program, and the
anti-PD-L1 and anti-GITR antibodies; the risk that early
preclinical and clinical results that supported our decision to
move forward with TG-1101, TGR-1202, the IRAK4 inhibitor program,
the BET inhibitor program, and the anti-PD-L1 and anti-GITR
antibodies will not be reproduced in additional patients or in
future studies; the risk that trends observed which underlie
certain assumptions of future performance of TGR-1202 will not
continue, the risk that TGR-1202 will not produce satisfactory
safety and efficacy results to warrant further development
following the completion of the current Phase 1 study; the risk
that the combination of TG-1101 and TGR-1202, referred to as
TG-1303, will not prove to be a safe andefficacious backbone for
triple and quad combination therapies; the risk that the data (both
safety and efficacy) from future clinical trials will not coincide
with the data produced from prior preclinical and clinical trials;
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
CONTACT:
Jenna
Bosco
Vice President,
Investor Relations
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email:
ir@tgtxinc.com