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 6, 2016
TG Therapeutics, Inc.
(Exact Name of
Registrant as Specified in Charter)
|
Delaware
(State or Other
Jurisdiction
of
Incorporation)
|
001-32639
(Commission File
Number)
|
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.
|
Item 8.01. Other Events.
On December 6,
2016, TG Therapeutics, Inc. issued press releases announcing
presented data from three combination studies involving the
Company’s lead compounds, TGR-1202 and TG-1101 (ublituximab)
in combination with other compounds, at the 58th American Society
of Hematology (ASH) Annual Meeting, being held in San Diego, CA. A
copy of the press release is being filed as Exhibit 99.1 and
incorporated in this Item by reference. In addition, on December 6,
2016 the Company also issued a press releasing announcing that the
target enrollment for the GENUINE Phase 3 study has been met and
enrollment will be closed shortly. A copy of the press release is
being filed as 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 6, 2016.
99.2 Press
Release, dated December 6, 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.
|
|
TG Therapeutics, Inc.
|
|
|
(Registrant)
|
|
|
|
|
|
|
|
|
|
|
Date: December 6,
2016
|
|
|
|
By: /s/
Sean A.
Power
|
|
|
Sean A.
Power
|
|
|
Chief Financial
Officer
|
|
|
|
INDEX
TO EXHIBITS
|
|
|
|
|
Exhibit
|
|
|
|
Number
|
|
Description
|
|
|
|
|
|
99.1.
|
|
Press Release,
dated December 6, 2016.
|
|
|
|
|
|
99.2
|
|
Press Release,
dated December 6, 2016.
|
|
|
|
|
Exhibit 99.1
TG
Therapeutics, Inc. Announces Double & Triple Combination
Therapy Data Presentations at the 58th American Society of
Hematology Annual Meeting
Combination of TG-1101, TGR-1202 and bendamustine resulted in 71%
ORR, including 43% complete response rate, in relapsed or
refractory DLBCL
TGR-1202 continues to demonstrate a favorable and differentiated
safety profile when combined with a variety of agents
SAN
DIEGO, CA (December 6, 2016) - TG Therapeutics, Inc. (NASDAQ:TGTX),
announced the presentation yesterday of data from three combination
studies involving the Company’s lead compounds, TGR-1202, the
Company’s once-daily PI3K delta inhibitor, and TG-1101
(ublituximab), the Company’s novel glycoengineered anti-CD20
monoclonal antibody at the 58th American Society of
Hematology (ASH) Annual Meeting, in San Diego,
California.
Michael
S. Weiss, the Company’s Executive Chairman and Interim CEO
stated, “We are very pleased to continue to see a highly
differentiated safety profile for TGR-1202 across multiple double
and triple combination studies with a high level of activity. Each
of the four clinical studies presented at the ASH meeting, enhanced
our overall understanding of the breadth of activity of TGR-1202.
In addition to DLBCL, FL and CLL, where we have already shown data
previously, it was nice to see the flexibility of TGR-1202 and its
ability to be combined with brentuximab vedotin in relapsed or
refractory Hodgkin’s and with ruxolitinib in
Myelofibrosis.” Mr. Weiss continued, “We are also
encouraged by the triple combination data of TG-1101, TGR-1202, and
bendamustine in relapsed or refractory, difficult to treat, DLBCL
and FL patients which showed no discontinuations for a treatment
related adverse event, as well as an 80% overall response rate
across both DLBCL and FL patients and a high level of CR’s.
We, and our investigators, believe this triplet combination is a
promising regimen and plan to study it in this patient population
in a registration-directed trial.”
Highlights from
yesterday’s presentations include the following:
Poster
Presentation: Combination of Ublituximab, TGR-1202, and
Bendamustine Demonstrates Significant Activity in Patients with
Advanced DLBCL and Follicular Lymphoma (Abstract Number
4197)
This
poster presentation includes data from patients with relapsed or
refractory Diffuse Large B-Cell Lymphoma (DLBCL) or Follicular
Lymphoma (FL) treated with the triple combination of TG-1101
(ublituximab), TGR-1202 and bendamustine. Nineteen patients were
evaluable for safety of which 15 were evaluable for efficacy (3
patients were too early to evaluate and 1 patient had a non-related
adverse event (AE) prior to efficacy assessment). The triple
combination appears well tolerated with no discontinuations for a
treatment related AE. Neutropenia and anemia were the only Grade
3/4 AE’s occurring in more than 1 patient. Importantly, no
Grade 3/4 transaminitis was reported, no events of pneumonia or
pneumonitis, and only 1 transient event of Grade 3 diarrhea, with a
duration of 1 day, was observed. Eleven patients (58%) were
refractory to prior treatment. 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.
Efficacy highlights
from this poster include:
●
71% (5 of 7)
Overall Response Rate (ORR), including a 43% Complete Response (CR)
rate observed in patients with relapsed or refractory
DLBCL
●
88% (7 of 8) ORR,
including a 37% CR rate observed in patients with relapsed or
refractory FL 4/6 CR’s that
were achieved between the DLBCL and FL groups occurred at the first
8 week efficacy assessment
●
First response
assessment occurred at Month 3 following initiation of therapy,
with durable responses observed notably amongst DLBCL
patients.
Poster
Presentation: A Phase I Trial of TGR-1202, a Next Generation
Once-Daily PI3Kd Inhibitor, in Combination with Brentuximab
Vedotin, in Patients with Relapsed/Refractory Hodgkins Lymphoma
(Abstract Number
4146)
This
poster presentation includes data from patients with relapsed and
refractory Hodgkin’s Lymphoma (HL) treated with TGR-1202 at
either 400mg or 600mg dosed orally once daily in combination with
brentuximab vedotin in continuous 21 day cycles. 14 patients were
evaluable for safety, of which 11 were evaluable for efficacy (3
discontinued prior to disease evaluation (2 AE’s and 1
withdrew consent)). 43% (6 of 14) of patients had prior exposure to
brentuximab vedotin and all were refractory to prior brentuximab
vedotin therapy. The combination demonstrated tolerability with
nausea, diarrhea, and neutropenia being the most prevalent adverse
events. Notably all but one case of diarrhea was Grade 1 or 2 in
severity.
Efficacy highlights
from this poster include:
●
60% (3 of 5) ORR,
including a 40% CR rate observed across brentuximab vedotin
refractory patients
●
64% (7 of 11) ORR,
including a 45% CR rate observed across all patients
treated
Oral Presentation:
Preliminary Results from a Phase I Dose Escalation Trial of
Ruxolitinib and the
PI3Kd Inhibitor TGR-1202 in Myelofibrosis (Abstract Number
1125)
This
oral presentation includes data from patients with myelofibrosis
treated with the combination of ruxolitinib, the JAK1/2 inhibitor
and TGR-1202. The combination was well tolerated and efficacious in
the twelve patients treated. The most prevalent adverse events
deemed at least possibly related to TGR-1202 included anemia,
thrombocytopenia, neutropenia, AST/ALT elevation and amylase/lipase
elevation and diarrhea, all of which were notably Grade 1/2 with
the exception of Grade 3 amylase/lipase elevation seen in 2
patients (16.7%), and Grade 3 diarrhea seen in 1 patient (8.3%).
Presentation highlights included:
●
The patient
population enrolled was advanced, with the majority having 2 or
more prior mutations at baseline;
●
Per protocol, all
enrolled patients were on a stable dose of ruxolitinib monotherapy
with best response to ruxolitinib monotherapy achieved prior to
enrollment;
●
Following the
addition of TGR-1202, 11/12 patients experienced improvement in
hemoglobin, many with a concomitant reduction in platelet counts
indicating clinical benefit beyond ruxolitinib monotherapy;
and
●
83% of study
participants experienced clinical benefit (hematologic improvement,
reduced spleen size and/or improvement in symptoms) including one
patient who achieved a CR and continues on study, now out 72
weeks
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:
TG Therapeutics held an investor and analyst
reception yesterday, at the Marriott Gaslamp, in San Diego,
California. The audio file and slide presentation are available for
review on the Events page, located within the Investors & Media
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, 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 that the GENUINE Phase 3 Study has
Reached Target Enrollment
Top-line data expected first half 2017
NEW
YORK, NY (December 6, 2016) - TG Therapeutics, Inc. (NASDAQ:TGTX),
today announced that the target enrollment of 120 patients in the
GENUINE Phase 3 study has been met and enrollment will be closed
shortly. The GENUINE Phase 3 study is a randomized study of
TG-1101, the Company’s novel, glycoengineered
anti-CD20 monoclonal antibody in combination with ibrutinib,
the oral Bruton’s tyrosine kinase (BTK), versus ibrutinib
alone in approximately 120 patients with high-risk relapsed or
refractory Chronic Lymphocytic Leukemia (CLL). In October, the
study was modified to convert the primary endpoint solely to
Overall Response Rate (ORR). If the study results are positive, and
subject to a positive outcome of pre-BLA meeting with the FDA, the
Company plans to utilize the results to file for accelerated
approval. The Company expects to release top-line data from the
GENUINE Phase 3 study in the first half of 2017.
Michael
S. Weiss, the Company’s Executive Chairman and Interim CEO
commenting on the announcement stated, “Today’s news
puts us on a clear path toward our first pivotal data for TG-1101.
As demonstrated in our Phase 2 study evaluating TG-1101 plus
ibrutinib, we believe the addition of an anti-CD20 monoclonal
antibody can enhance the clinical response of single agent
ibrutinib by more rapidly reducing tumor burden, increasing the
rate of response, deepening responses and, ideally, leading to
better long-term outcomes. Overall response rate has been utilized
as an acceptable surrogate endpoint for improved progression free
survival and overall survival for a number of recent approvals in
high-risk CLL and we believe the results, if positive, may support
an accelerated approvable for the combination. We want to thank our
clinical collaborators and their patients for their participation
in this study.”
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 the timing of the completion of the
GENUINE study, timing of the completion of the UNITY-CLL study,
timing of filing of a BLA for TGR-1101, and projected cost savings
from amending the GENUINE study 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 GENUINE
or the UNITY-CLL trials; the risk that the clinical results from
the GENUINE or UNITY-CLL studies will be not positive and/or will
not support regulatory approval of TG-1101 or TGR-1202; the risk
that the FDA will not grant us a pre-BLA meeting to discuss the
results of the GENUINE study; the risk that we will not file a BLA
for TG-1101 or an NDA for TGR-1202 based on either the GENUINE or
the UNITY-CLL; the risk that despite early positive trends in
enrollment in the UNITY-CLL study that enrollment will be delayed
beyond our projections; the risk that the planned interim analysis
will not allow early closure of the single agent arms in the
UNITY-CLL study, necessitating enrollment beyond the projected 450
patients, which would extend enrollment beyond our projections; the
risk that safety issues or trends will be observed in the GENUINE
study or the UNITY-CLL study that prevent approval of either
TG-1101 and/or TGR-1202 or require us to terminate either the
GENUINE study or the UNITY-CLL study prior to completion; the risk
that the data (both safety and efficacy) from future clinical
trials will not coincide with the data produced from prior
pre-clinical and clinical trials; the risk that the GENUINE study,
as amended or the UNITY-CLL study, or any of our other
registration-directed clinical trials as designedor amended may not
be sufficient or acceptable to support regulatory approval; the
risk that trials will take longer to enroll than expected; the risk
that the projected cost savings to be realized by amending the
GENUINE trial will not be realized; 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