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 8,
2019
(Exact
Name of Registrant as Specified in Charter)
|
(State
or Other Jurisdiction
of
Incorporation)
|
(Commission File
Number)
|
(IRS
Employer Identification No.)
|
(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:
|
Title
of Class
|
Trading
Symbol(s)
|
Exchange
Name
|
|
|
|
|
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 8, 2019, TG Therapeutics, Inc. (the “Company”)
issued a press release announcing data from the Phase 1/2 study of
the triple combination of ublituximab (TG-1101), the
Company’s novel glycoengineered anti-CD20 monoclonal
antibody, in combination with umbralisib (TGR-1202), the
Company’s oral, dual inhibitor of PI3K delta and CK1 epsilon,
and venetoclax, in patients with relapsed/refractory chronic
lymphocytic leukemia (CLL). On December 9, 2019, the Company also
announced Phase 1 clinical data for TG-1701, the Company’s
covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, in
patients with relapsed/refractory B-cell malignancies. Both press
releases summarized data presented during the 61st American Society of
Hematology (ASH) Annual Meeting and Exposition. 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.
Press Release,
dated December 8, 2019.
Press Release,
dated December 9, 2019.
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 9, 2019
|
By:
|
/s/
Sean A. Power
|
|
|
|
|
Sean A.
Power
|
|
|
|
|
Chief
Financial Officer
|
|
Exhibit 99.1
TG Therapeutics Announces Oral Presentation of Umbralisib,
Ublituximab and Venetoclax Triple Combination Phase I/II Data in
Relapsed/Refractory CLL at the 61st American Society of
Hematology Annual Meeting and Exposition
100% overall response rate (ORR) in relapsed/refractory CLL
patients treated with U2 (umbralisib + ublituximab) plus venetoclax
at cycle 7 (n=13)
100% of patients (n=9) achieved undetectable MRD in the peripheral
blood after 12 months of therapy and 78% achieved undetectable MRD
in bone marrow and have stopped all therapy
No patients have progressed to date
Investor and analyst event to be held on Monday, December 9,
2019 at 7:30 PM ET at the
Hyatt Regency Orlando featuring a fireside chat
with leading clinical investigators
NEW
YORK, NY (December 8, 2019) - TG Therapeutics, Inc. (NASDAQ: TGTX),
today announced triple therapy data from the Phase I/II study of
ublituximab (TG-1101), the Company’s novel glycoengineered
anti-CD20 monoclonal antibody, in combination with umbralisib
(TGR-1202), the Company’s oral, dual inhibitor of PI3K delta
and CK1 epsilon, and venetoclax, in patients with
relapsed/refractory chronic lymphocytic leukemia (CLL). Data from
this trial were presented this morning during an oral session at
the 61st
American Society of Hematology (ASH) Annual Meeting and
Exposition.
Michael
S. Weiss, Executive Chairman and Chief Executive Officer, stated,
“We are extremely pleased to share the first data from the
triple combination of U2 (umbralisib and ublituximab) and
venetoclax, which we believe has the potential to offer patients
with CLL a highly active, time-limited, and generally well
tolerated treatment option. It was exciting to see that for those
patients followed for at least 12 months at the time of the
presentation, there was a 100% ORR, and all of those patients
achieved MRD negativity in the peripheral blood, with 7 of those 9
patients also achieving MRD negativity in the bone marrow. We look
forward to updating these data at future conferences as more
patients are followed for 12 months and longer.” Mr. Weiss
continued, “We were also excited to see that 87% of patients
responded to the U2 combination after just three months of
treatment prior to the introduction of venetoclax. We believe this
further demonstrates the activity of the U2 combination that is
being studied in our UNITY-CLL Phase 3 trial, which we expect data
from in the coming weeks or months.”
Below
are highlights from the oral presentation.
Title: A
Phase 1/2 Study of Umbralisib, Ublituximab and Venetoclax in
Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
(CLL)
This
oral presentation includes data from patients with relapsed or
refractory CLL treated with the triple combination of ublituximab,
umbralisib, and venetoclax. Twenty-seven patients were evaluable
for safety and 23 were evaluable for efficacy. Data highlights
include:
●
Regimen was administered with 3 cycles of U2 induction/debulking to
reduce the risk of tumor lysis syndrome (TLS), followed by the
combination of umbralisib and venetoclax starting in cycle 4.
Patients who were bone marrow MRD negative after cycle 12 stopped
all therapy.
●
Overall response rate (ORR) of 87% (20/23) after U2 induction
period at cycle 3, prior to introduction of venetoclax, in
relapsed/refractory CLL patients, including patients refractory to
ibrutinib
●
U2 induction appeared to reduce venetoclax TLS risk, with no
patients remaining as TLS high-risk following 3 cycles of
U2
●
13 patients treated for >7 cycles and 9 patients for
> 12
cycles:
o
100% ORR (13/13) after cycle 7 for the triple
combination
o
100% ORR (9/9) including 44% Complete Response (CR) after cycle 12
for the combination
o
100% (9/9) of patients had undetectable minimal residual disease
(MRD) (<0.01%) in peripheral blood after 12 cycles of therapy;
and
o
78% (7/9) of patients who completed 12 cycles of therapy had
undetectable MRD in bone marrow and have stopped
therapy
●
No patients (n = 27) have progressed to date with a median
follow-up of 6.4 months
●
Triple combination was generally well tolerated with no events of
TLS observed
An
open-label, multicenter, Phase 2 study evaluating U2 plus
venetoclax (ULTRA-V) in treatment naïve and previously treated
CLL is now open for enrollment.
Remaining ASH Presentation Details
●
Title: Phase 1 Study of
TG-1701, a Selective Irreversible Inhibitor of Bruton's Tyrosine
Kinase (BTK), in Patients with Relapsed/Refractory B-Cell
Malignancies
o
Publication Number:
4001
o
Session: 623. Mantle Cell,
Follicular, and Other Indolent B-Cell Lymphoma—Clinical
Studies: Poster III
o
Date and Time: Monday, December
9, 2019; 6:00 PM - 8:00 PM ET
o
Location: Orange County
Convention Center, Hall B
o
Presenter: Chan Cheah,
MD, Sir
Charles Gairdner Hospital, Hollywood Private Hospital, University
of Western Australia, Blood Cancer Research Western
Australia
Following
the presentation, the data presented will be available on the
Publications page of the Company’s website at https://www.tgtherapeutics.com/publications/.
TG THERAPEUTICS INVESTOR & ANALYST EVENT
TG
Therapeutics will host an event on Monday, December 9, 2019
beginning at 7:30 PM ET with a featured fireside chat beginning
promptly at 8:00 PM ET. The event will take place at the Hyatt
Regency Orlando, in the Plaza International Ballroom I. A live
webcast will be available on the Events page, located within the
Investors & Media section of the Company’s website at
http://ir.tgtherapeutics.com/events, as well as archived for future
review. This event will also be broadcast via conference call. 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 December 2019 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. 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 oral, once-daily inhibitor of PI3K-delta.
Umbralisib uniquely inhibits CK1-epsilon, which may allow it to
overcome certain tolerability issues associated with first
generation PI3K-delta inhibitors. 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, its covalently-bound
Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as
its anti-CD47/CD19 bispecific antibody, TG-1801, into Phase 1
development. 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 data from
the UNITY-CLL Phase 3 trial will not be available in the planned
timeframe or not be sufficient to support a regulatory filing; 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 the combination of U2 plus venetoclax
will not prove to be a safe or efficacious treatment and will not
warrant further testing; the risk that the combination of U2 plus
venetoclax will not ultimately result in a time limited therapy;
the risk that the combination of U2 plus venetoclax, if approved,
will not be utilized broadly or at all by academic or community
physicians;. 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 Announces Phase I Data Presentation for TG-1701, a
Once-Daily BTK Inhibitor, as a Single Agent and in Triple
Combination with Ublituximab and Umbralisib (U2), at the
61st
American Society of Hematology Annual Meeting and
Exposition
Proprietary triplet of U2 plus TG-1701 (BTK inhibitor) induced 86%
ORR (6 of 7) in patients with relapsed/refractory NHL and CLL at
the lowest dose of TG-1701 tested
Single agent TG-1701 induced responses at multiple dose levels
(including the lowest dose tested) across multiple B-cell
diseases
TG-1701 demonstrates an encouraging safety profile to date, with
dose escalation continuing for the combination with U2
Yesterday, TG announced positive early data from the combination of
U2 plus venetoclax in an oral presentation at ASH (click here for
PR)
Investor and analyst event to be held today, Monday, December 9,
2019 at 7:30 PM ET at the
Hyatt Regency Orlando, featuring a fireside chat
with leading clinical investigators
NEW
YORK, NY (December 9, 2019) - TG Therapeutics, Inc. (NASDAQ: TGTX),
today announced the first clinical data from the Company’s
once daily, oral, BTK inhibitor, TG-1701, as a single agent and as
a triple therapy in combination with ublituximab (TG-1101), the
Company’s novel glycoengineered anti-CD20 monoclonal
antibody, and umbralisib (TGR-1202), the Company’s oral, dual
inhibitor of PI3K delta and CK1 epsilon, in patients with
relapsed/refractory non-Hodgkin’s lymphoma (NHL) and chronic
lymphocytic leukemia (CLL). Data from this Phase I trial are being
presented this evening during a poster session at the
61st
American Society of Hematology (ASH) Annual Meeting and
Exposition.
Michael
S. Weiss, Executive Chairman and Chief Executive Officer, stated,
“We are highly encouraged by the first clinical data
presented from our once daily, BTK inhibitor, TG-1701, which has
demonstrated superior selectivity for BTK compared to ibrutinib in
an in vitro whole kinome
screening. The data presented today show that TG-1701 is an active
BTK inhibitor as a single agent and that the combination of U2 plus
TG-1701 has been generally well tolerated and active with 6 of 7
patients responding to the triple therapy at 100 mg QD, the lowest
dose of TG-1701 tested. We look forward to continuing dose
escalation of TG-1701 in the combination arm and identifying the
optimal dose for this therapy.” Mr. Weiss continued,
“Our goal has always been to develop the best possible
combination treatment options for patients, and we are excited to
present the first data from a triple combination study in which all
of the agents are being developed by TG. We believe this
proprietary combination has the potential to enhance the results of
BTK inhibitor therapy alone and offer patients early and deep
responses with a tolerable safety profile.”
Below
are highlights from today’s poster presentation.
Poster Presentation: Phase 1 Study of
TG-1701, a Selective Irreversible Inhibitor of Bruton's Tyrosine
Kinase (BTK), in Patients with Relapsed/Refractory B-Cell
Malignancies
This presentation includes safety information from 30 patients, 21
patients treated with single agent TG-1701, and 9 patients treated
with the triple combination of TG-1701 plus U2.
●
TG-1701, a once daily BTK inhibitor, demonstrates an encouraging
safety profile to date, with clinical and pharmacodynamic activity
at all dose levels evaluated
●
30 patients have been treated with TG-1701 at doses that ranged
from 100mg to 400mg once daily for TG-1701 monotherapy; dose
escalation continues in the triple combination arm
●
Single agent TG-1701 produced partial responses at multiple dose
levels (including the lowest dose tested) across multiple B-cell
diseases, including mantle cell lymphoma (MCL), chronic lymphocytic
leukemia (CLL), Waldenström's macroglobulinemia (WM), and
small lymphocytic lymphoma (SLL)
●
86% (6/7) of patients treated with 100 mg TG-1701 plus U2 have
achieved a response
o
4 patients with follicular lymphoma (FL): 2 Complete Responses
(CR), 1 Partial Response (PR) and 1 Stable Disease
(SD)
o
1 PR in marginal zone lymphoma (MZL); 1 PR in Waldenström's
macroglobulinemia (WM); and 1 PR in diffuse large B-cell lymphoma
(DLBCL)
●
All patients treated with the triple combination of TG-1701 plus U2
remain on study
ASH Poster Presentation Details
●
Title: Phase 1 Study of
TG-1701, a Selective Irreversible Inhibitor of Bruton's Tyrosine
Kinase (BTK), in Patients with Relapsed/Refractory B-Cell
Malignancies
o
Publication Number:
4001
o
Session: 623. Mantle Cell,
Follicular, and Other Indolent B-Cell Lymphoma—Clinical
Studies: Poster III
o
Date and Time: Monday, December
9, 2019; 6:00 PM - 8:00 PM ET
o
Location: Orange County
Convention Center, Hall B
o
Presenter: Chan Cheah,
MD, Sir
Charles Gairdner Hospital, Hollywood Private Hospital, University
of Western Australia, Blood Cancer Research Western
Australia
Below
recaps highlights from yesterday’s oral presentation of U2
plus venetoclax.
Title: A
Phase 1/2 Study of Umbralisib, Ublituximab and Venetoclax in
Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
(CLL)
This
oral presentation includes data from patients with relapsed or
refractory CLL treated with the triple combination of ublituximab,
umbralisib, and venetoclax. Twenty-seven patients were evaluable
for safety and 23 were evaluable for efficacy. Data highlights
include:
●
Regimen was administered with 3 cycles of U2 induction/debulking to
reduce the risk of tumor lysis syndrome (TLS), followed by the
combination of umbralisib and venetoclax starting in cycle 4.
Patients who were bone marrow MRD negative after cycle 12 stopped
all therapy.
●
Overall response rate (ORR) of 87% (20/23) after U2 induction
period at cycle 3, prior to introduction of venetoclax, in
relapsed/refractory CLL patients, including patients refractory to
ibrutinib
●
U2 induction appeared to reduce venetoclax TLS risk, with no
patients remaining as TLS high-risk following 3 cycles of
U2
●
13 patients treated for >7 cycles and 9 patients for
> 12
cycles:
o
100% ORR (13/13) after cycle 7 for the triple
combination
o
100% ORR (9/9) including 44% Complete Response (CR) after cycle 12
for the combination
o
100% (9/9) of patients had undetectable minimal residual disease
(MRD) (<0.01%) in peripheral blood after 12 cycles of therapy;
and
o
78% (7/9) of patients who completed 12 cycles of therapy had
undetectable MRD in bone marrow and have stopped
therapy
●
No patients (n=27) have progressed to date with a median follow-up
of 6.4 months
●
Triple combination was generally well tolerated with no events of
TLS observed
An
open-label, multicenter, Phase 2 study evaluating U2 plus
venetoclax (ULTRA-V) in treatment naïve and previously treated
CLL is now open for enrollment.
All data presented is available on the Publications page of the
Company’s website at https://www.tgtherapeutics.com/publications/.
TG THERAPEUTICS INVESTOR & ANALYST EVENT
TG
Therapeutics will host an event on Monday, December 9, 2019
beginning at 7:30 PM ET with a featured fireside chat beginning
promptly at 8:00 PM ET. The event will take place at the Hyatt
Regency Orlando, in the Plaza International Ballroom I. A live
webcast will be available on the Events page, located within the
Investors & Media section of the Company’s website at
http://ir.tgtherapeutics.com/events, as well as archived for future
review. This event will also be broadcast via conference call. 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 December 2019 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. 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 oral, once-daily inhibitor of PI3K-delta.
Umbralisib uniquely inhibits CK1-epsilon, which may allow it to
overcome certain tolerability issues associated with first
generation PI3K-delta inhibitors. 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, its covalently-bound
Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as
its anti-CD47/CD19 bispecific antibody, TG-1801, into Phase 1
development. 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 data from
the UNITY-CLL Phase 3 trial will not be available in the planned
timeframe or not be sufficient to support a regulatory filing; 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 the combination of U2 plus venetoclax
will not prove to be a safe or efficacious treatment and will not
warrant further testing;the risk that the combination of U2 plus
venetoclax will not ultimately result in a time limited therapy;
the risk that the combination of U2 plus venetoclax, if approved,
will not be utilized broadly or at all by academic or community
physicians; the risk that the preliminary results for TG-1701 will
not be reproduced in additional data sets; and the risk that future
results from the combination of U2 plus TG-1701 will not be
comparable in safety, efficacy, or both, to the early results
presented or to those results previously seen with the combination
of U2 plus ibrutinib. 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