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): April 1, 2019
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.
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 April 1, 2019,
TG Therapeutics, Inc. (the “Company”) issued a press
release announcing the presentation of positive interim data from
its ongoing
single-arm marginal zone lymphoma (MZL) cohort of its Phase 2b
clinical trial known as UNITY-NHL, at the
2019 American Association of Cancer Research (AACR) Annual
Meeting. 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 April 1,
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: April 1,
2019
|
|
|
|
By: /s/
Sean A.
Power
|
|
|
Sean A.
Power
|
|
|
Chief Financial
Officer
|
|
|
|
Exhibit
99.1
TG Therapeutics Reports Positive Interim Data from UNITY-NHL Phase
2b Trial Evaluating Umbralisib Monotherapy in Patients with
Marginal Zone Lymphoma at the 2019 AACR Annual Meeting
Overall response rate (ORR) of 52%
(N=42), with complete response (CR) rate of 19%, by central
independent review committee (IRC)
Responses were durable, with median duration of response (DOR) not
reached at median 12.5 months follow-up, and all patients in
complete response remain on study
Umbralisib was well tolerated with a safety profile that appeared
to be maintained with prolonged exposure
Umbralisib previously granted Breakthrough Therapy Designation for
the treatment of patients with relapsed/refractory MZL
Company to host conference call today, April 1, 2019 at 12:00pm
(noon) ET, with Dr. Nathan Fowler of MD Anderson Cancer Center and
Study Chair of the MZL cohort, to discuss the interim
results
NEW
YORK, NY, April 1, 2019 (GLOBE NEWSWIRE)
– TG Therapeutics, Inc.
(NASDAQ: TGTX) today reported positive interim data from the
ongoing single-arm marginal zone lymphoma (MZL) cohort of its Phase
2b clinical trial known as UNITY-NHL. The MZL cohort of UNITY-NHL
is designed to investigate umbralisib as a single agent in patients
with relapsed or refractory MZL. Umbralisib is an investigational,
oral, once daily PI3K delta inhibitor with unique inhibition of CK1
epsilon and is currently under development for the treatment of
non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia
(CLL).
The interim data were reported this morning by Dr. Nathan Fowler,
Associate Professor of Medicine and Director of Clinical Research
in the Department of Lymphoma/Myeloma at the University of Texas MD
Anderson Cancer Center and Study Chair of the UNITY-NHL MZL cohort,
during this morning’s official 2019 Press Program at the
American Association of Cancer Research (AACR) Annual Meeting. Dr.
Fowler will also present the data during an oral session this
afternoon (details below).
Summary of Data Presented:
The MZL cohort of UNITY-NHL enrolled patients with relapsed or
refractory MZL who had received prior treatment
with one or more lines of therapy including at least one
anti-CD20 regimen. In August 2018, the
trial completed enrollment with 69 treated patients. The interim
data reported today included safety and tolerability data on all 69
treated patients (safety population) and efficacy data on 42
patients who were enrolled at least 9 cycles (28 day cycles) prior
to the data cut-off date (interim efficacy population). The primary
endpoint is overall response rate (ORR) as assessed by IRC using
criteria adopted from the International Working Group criteria for
malignant lymphoma.
Efficacy
Analysis of the interim efficacy population (n=42) with a median
follow-up of 12.5 months showed the following:
|
|
Interim Efficacy Population (n=42)
|
|
Overall Response Rate by IRC (CR + PR), %
|
52%
|
|
Complete
Response by IRC (CR), (%)
|
19%
|
|
Partial
Response by IRC (PR), (%)
|
33%
|
|
Median duration of response, months
|
NR (95% CI: 8.4 – NE)
|
CI = confidence interval; NR = not reached; NE = not estimable; SD
= stable disease
Additional Efficacy Highlights:
●
88%
clinical benefit rate by IRC (defined as patients obtaining
Complete Response + Partial Response + Stable Disease)
●
All
patients achieving a Complete Response by IRC remain on study
(range: 10.1+ to 15.7+ months)
●
86%
of patients had a reduction in tumor burden
●
Median
time to initial response was 2.7 months
●
Kaplan-Meier
(KM) estimate of progression-free survival (PFS) at 12 months was
66%, with the median PFS not reached
Safety
Interim safety data were presented for all 69 treated patients with
a median duration of exposure of 6.9 months. No unexpected
toxicities were observed. The most common adverse events were
diarrhea, nausea, and fatigue, with the majority of events Grade 1
in severity. The most frequent grade 3 or higher adverse events
were neutropenia, diarrhea and ALT/AST increase, observed in 13%,
10% and 10% of patients, respectively.
A subgroup analysis of patients treated for greater than 6 cycles
(n=41) was also conducted to evaluate long-term incidence of key
toxicities of interest occurring after 6 cycles of treatment.
Median duration of treatment of this subgroup was 10.1 months
(range: 5.6 – 19.1 months). In this subgroup, grade 3 or
higher adverse events of interest were rare, limited to 2 patients
with diarrhea and 1 patient with pneumonitis, with no events of
ALT/AST elevation, pneumonia, or colitis.
Key Safety Findings (n=69):
●
No events of
colitis were reported and only 1 event of Grade 3 pneumonitis was
reported
●
Grade 3 infections
were limited, occurring in 3 patients (bronchitis, pneumonia, and
influenza)
●
Discontinuations
due to umbralisib-related AEs were limited (14%) with no
discontinuations after 6 months due to a treatment-related
AE
Dr. Nathan Fowler, Associate Professor of Medicine and Director of
Clinical Research in the Department of Lymphoma/Myeloma at The
University of Texas MD Anderson Cancer Center and the Study Chair
of the UNITY-NHL MZL cohort, stated, “MZL remains an
incurable disease with few treatment options for patients who
relapse after first-line chemoimmunotherapy. The exciting results
presented today suggest that this oral targeted therapeutic has
significant activity against relapsed/refractory marginal zone
lymphoma and offers hope for patients.” Dr. Fowler continued,
“The adverse event and clinical activity data are highly
encouraging at this point and we are excited to continue following
patients for a longer time. With the results reported thus far,
umbralisib has the potential to make a real difference for patients
with relapsed/refractory marginal zone
lymphoma.”
Michael S. Weiss, Executive Chairman and Chief Executive Officer
of TG Therapeutics stated, "We are very excited about
these interim data and believe the results today demonstrate the
activity and differentiated safety and tolerability profile of
umbralisib at our Phase 3 dose of 800 mg once per day.” Mr.
Weiss continued, “As announced previously, the efficacy for
the entire population has already reached our target range of
40-50% ORR and we look forward to presenting the final data from
the entire MZL cohort later this year when all patients have had
the opportunity to be followed for at least 9 cycles. In addition,
we look forward to discussing the results with the FDA with a goal
of filing for accelerated approval by year end.”
CONFERENCE CALL INFORMATION
The
Company will host a conference call today, Monday April 1,
2019, at 12:00pm (noon) ET. Michael S. Weiss, Chief Executive
Officer of TG Therapeutics, will host the call and Dr. Nathan
Fowler, Associate Professor of Medicine and Director of Clinical
Research in the Department of Lymphoma/Myeloma at The University of
Texas MD Anderson Cancer Center in Houston and Study Chair of the
MZL cohort, will review the UNITY-NHL interim MZL
data.
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 AACR Update
Call.
A live
webcast and accompanying slides will be available on the Events
page, located within the Investors & Media section, of the
Company's website at http://ir.tgtherapeutics.com/events.
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.
2019 AACR ORAL PRESENTATION DETAILS
●
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
Presentation Time: 4:20 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
The
full text of the abstract is now available and can be accessed via
the AACR meeting website at www.aacr.org.
The slides to be presented in this afternoon’s oral
presentation are available on the Company’s corporate website
at www.tgtherapeutics.com/publications.cfm.
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, 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 central Independent
Review Committee (IRC) assessment.
The MZL
cohort completed enrollment in August 2018 with a total of 69
patients enrolled and receiving at least one dose of umbralisib. In
February of 2019, the Company announced that the MZL cohort met its
primary endpoint of ORR as determined by central IRC for all
treated patients (n=69). While the study has already met the
Company’s target guidance of 40-50% ORR, the final analysis
of ORR will be conducted when 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).
ABOUT BREAKTHROUGH THERAPY DESIGNATION
The
Company announced in January of 2019 that the U. S. Food and Drug
Administration (FDA) granted Breakthrough Therapy Designation for
umbralisib for the treatment of adult patients with marginal
zone lymphoma who have received at least one prior anti-CD20
regimen.
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 multiple 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 into
Phase 1 clinical development, TG-1501, its anti-PD-L1 monoclonal
antibody, TG-1701, its covalently-bound Bruton’s Tyrosine
Kinase (BTK) inhibitor and TG-1801, its anti-CD47/CD19 bispecific
antibody. 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: the risk that the interim data (the “Interim
Results”) from the UNITY-NHL MZL cohort released today will
not be reproduced when the final analysis is conducted on all
patients later this year, including the risk that the final results
will demonstrate a lower ORR and/or enhanced toxicities, which may
not support a filing for accelerated approval; the risk that even
if the Interim Results are reproduced in the final analysis of the
UNITY-NHL MZL cohort or that the final results otherwise meet the
Company’s target ORR of 40-50%, that the final results will
still be insufficient to support a filing for accelerated approval;
the risk that umbralisib will not receive accelerated approval
based on data from the UNITY-NHL MZL cohort even if the final
results are deemed positive by the Company and support a filing for
accelerated approval; the risk that the positive Interim Results
from the UNITY-NHL MZL cohort will not be reproduced in other
cohorts of the UNITY-NHL study or in other studies being conducted
by the Company; the risk that duration of response or progression
free survival data from the UNITY-NHL cohort when available for all
patients will not be positive or supportive of accelerated
approval; the risk that safety issues will arise when the final
safety data are cleaned and analyzed for all patients in the
UNITY-NHL MZL cohort; the risk that our belief that umbralisib has
a differentiated safety profile will not be shared by physicians or
the FDA or will not be reproduced in the final analysis of the
UNITY-NHL MZL cohort, in other cohorts of the UNITY-NHL study, in
the UNITY-CLL study or in any other of our on-going studies; the
risk that we are not able to successfully and cost effectively
complete all the preclinical, clinical and CMC requirements
necessary to support accelerated approval. 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
A. Bosco
Senior Vice
President,
Corporate
Communications
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email:
ir@tgtxinc.com