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): February 28, 2019
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 February 28,
2019, TG Therapeutics, Inc. (the “Company”) issued a
press release announcing data from the UNITY-NHL Phase 2b pivotal
trial evaluating umbralisib in patients with relapsed/refractory
marginal zone lymphoma. 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 February 28,
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.
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TG Therapeutics, Inc.
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(Registrant)
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Date: February 28,
2019
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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 Announces Positive Outcome from UNITY-NHL Phase 2b
Pivotal Trial Evaluating Umbralisib in Patients with
Relapsed/Refractory Marginal Zone Lymphoma
Study met the primary endpoint of Overall Response Rate
(ORR)
Interim data to be presented in an oral presentation at the 2019
American Association of Cancer Research (AACR) annual meeting on
April 1, 2019
Umbralisib was previously granted Breakthrough Therapy Designation
based on interim data from the marginal zone lymphoma (MZL) cohort
of the UNITY-NHL trial
Conference call to be held today, Thursday February 28, 2019 at
8:30 AM ET
NEW
YORK, NY, February 28, 2019 (GLOBE NEWSWIRE)
– TG Therapeutics, Inc. (NASDAQ: TGTX), a
biopharmaceutical company developing medicines for patients with
B-cell mediated diseases, today announced that the Marginal Zone
Lymphoma (MZL) cohort of the UNITY-NHL Phase 2b pivotal trial
evaluating umbralisib (TGR-1202), our novel, once daily, PI3K delta
inhibitor, met the primary endpoint of Overall Response Rate (ORR)
as determined by Independent Review Committee (IRC) for all treated
patients (n=69). The results met the Company’s target
guidance of 40-50% ORR.
Interim
safety and efficacy data from this study will be presented in an
oral presentation at the upcoming American Association of Cancer
Research (AACR) annual meeting on April 1, 2019 and full data from
this study are expected to be presented at a medical meeting later
this year. The company plans to discuss the results with the U.S.
Food and Drug Administration (FDA) regarding a potential new
drug application (NDA) filing for accelerated approval. Umbralisib
was recently granted Breakthrough Therapy Designation (BTD) by the
FDA for the treatment of adult patients with MZL who have received
at least one prior anti-CD20 regimen.
Michael
S. Weiss, Executive Chairman and Chief Executive Officer of TG
Therapeutics stated, “We are extremely pleased to announce
that the UNITY-NHL marginal zone lymphoma cohort evaluating
umbralisib monotherapy met the primary endpoint of ORR. While this
was an early look at the response data, we were excited to have
already met the target ORR, which we previously stated was
approximately 40%-50%. Importantly, with many patients still on
study, we anticipate the ORR will continue to improve with
additional follow-up, which will also provide us with critical
information on duration of response, progression free survival and
long-term safety and tolerability necessary to support an NDA
filing.”
Mr.
Weiss continued, “There are no fully approved drugs for MZL,
and thus remains an unmet medical need and we are excited by the
potential to offer a novel treatment for this underserved
population. We look forward to discussing the results with the FDA
as soon as possible and if all goes well, we believe we could be in
a position to file for accelerated approval for umbralisib by
year-end."
About the UNITY-NHL Phase 2b Study—Marginal Zone Lymphoma
Cohort
The
multicenter, open-label, UNITY-NHL Phase 2b study - Marginal Zone
Lymphoma cohort was designed to evaluate the safety and efficacy
of single agent umbralisib, the Company’s novel, once
daily, PI3K delta inhibitor, in patients with MZL who have received
at least one prior anti-CD20 regimen. The primary endpoint is
overall response rate (ORR) as determined by Independent Review
Committee (IRC) assessment. The primary analysis of ORR will be
conducted once all treated patients have had at least 9 cycles
(Cycle = 28 days) of follow-up. Secondary endpoints include safety,
duration of response, and progression-free survival
(PFS).
The MZL
cohort completed enrollment in August 2018 with a total of 69
patients enrolled and receiving at least one dose of umbralisib.
The positive ORR outcome announced today was based on all 69
enrolled and treated patients, however at this time all patients
have not yet been followed for a minimum of 9 cycles as required
for the primary analysis of ORR. Accordingly, the study is on-going
and patients with benefit on therapy (stable disease or in
response) remain on study. Safety data are currently being
analyzed.
Abstract
titles are now available online and can be accessed on the AACR
meeting website at www.aacr.org. The complete text of the abstract
will be available on the meeting website on Friday, March 29, 2019.
The presentation is expected to include a subset of patients from
the UNITY-NHL-Marginal Zone Cohort with long-term follow-up as of
the data cut-off. Additional details regarding the presentation are
included below.
●
Title: Umbralisib monotherapy demonstrates efficacy and
safety in patients with relapsed/refractory marginal zone lymphoma:
A multicenter, open-label, registration directed Phase II
study
o
Session Date and
Time: Monday April 1, 2019
3:00 PM - 5:00 PM ET
o
Session
Title: The Next Generation
of Clinical Trials in Molecularly-driven Therapy
o
Session
Location: Marcus
Auditorium- Bldg A-GWCC
o
Presenter: Nathan Fowler, MD, Associate Professor, Department
of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer
Center, Houston, TX
o
Abstract Number:
7821
Following
the presentation, the data presented will be available on the
Publications page, located within the Pipeline section, of the
Company’s website at www.tgtherapeutics.com/publications.cfm.
CONFERENCE CALL INFORMATION
The
Company will host a conference call today, Thursday, February
28, 2019 at 8:30 AM ET to discuss the UNITY-NHL MZL
results.
In
order to participate in the conference call, please call
1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.),
Conference Title: TG Therapeutics Update Call.
A live
webcast of this presentation will be available on the Events page,
located within the Investors & Media section, of the Company's
website at www.tgtherapeutics.com.
An audio recording of the conference call will also be available
for replay at www.tgtherapeutics.com,
for a period of 30 days after the call.
ABOUT MARGINAL ZONE LYMPHOMA
Marginal zone lymphoma (MZL) comprises a group of
indolent (slow growing) B-cell non-Hodgkin lymphomas
(NHLs) that
begin forming in the marginal zone of lymphoid tissue. With an
annual incidence of approximately 7,500 newly diagnosed patients,
MZL is the third most
common B-cell NHL accounting for
approximately eight percent of all NHL cases.i
MZL
consists of three different subtypes: extranodal MZL of the
mucosal-associated lymphoid tissue (MALT), nodal marginal zone
lymphoma (NMZL), and splenic marginal zone lymphoma
(SMZL).
ABOUT BREAKTHROUGH THERAPY DESIGNATION
The
FDA’s Breakthrough Therapy designation is intended to
expedite the development and review of a drug candidate that is
planned to treat a serious or life-threatening disease or condition
and preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement on one or more clinically
significant endpoints over available therapies.
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 the interim
clinical trial results from the UNITY-NHL MZL cohort that supported
Breakthrough Therapy Designation (BTD) or that were accepted for
presentation at AACR will not be reproduced in the final data, or
if positive, will not be sufficient to support a filing for
approval; the risk that the positive data from the UNITY-NHL MZL
cohort will not be reproduced in future studies or in other cohorts
of the UNITY-NHL study;the risk that the ORR data from the
UNITY-NHL MZL cohort will not improve over time;the risk that
umbralisib will not receive accelerated approval based on data from
the UNITY-NHL MZL cohort; the risk that duration of response or
progression free survival data from the UNITY-NHL cohort when
available will not be positive or supportive of approval; the risk
that safety issues will arise when the safety data is cleaned and
analyzed for the UNITY-NHL MZL cohort; the risk that the
differentiated tolerability profile for umbralisib previously
observed thus far in clinical trials will not be reproduced in the
UNITY-NHL study, the UNITY-CLL study or any other on-going studies.
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
i
Denlinger NM, Epperla N, William BM. Management of
relapsed/refractory marginal zone lymphoma: focus on ibrutinib.
Cancer Manag Res. 2018 Mar 27;10:615-624. doi:
10.2147/CMAR.S133291. eCollection 2018