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EX-99.3 - EXHIBIT 99.1 - TG THERAPEUTICS, INC. | v101617_ex993.htm |
EX-99.2 - EXHIBIT 99.1 - TG THERAPEUTICS, INC. | v101617_ex992.htm |
8-K - 8-K - TG THERAPEUTICS, INC. | v101617_8k.htm |
TG Therapeutics Provides Update on FDA Meeting for GENUINE Phase 3
Trial
Follow-up meeting with FDA expected before year end
NEW
YORK, October 16, 2017 - TG Therapeutics (NASDAQ: TGTX) announced
today that it has met with the U.S. Food and Drug Administration
(FDA) regarding the use of the results from the GENUINE Phase 3
trial to support a Biologics License Application (BLA) filing for
approval of TG-1101 (ublituximab), the Company's novel
glycoengineered anti-CD20 monoclonal antibody, in combination with
ibrutinib. During the meeting, the FDA confirmed that accelerated
approval based on Overall Response Rate (ORR) would be a review
issue. As part of the discussion, the FDA encouraged the Company to
consider future available therapy in its risk/benefit analysis as
part of any potential future BLA filing that may impact accelerated
approval.
The
Company and the FDA also discussed the potential use of Progression
Free Survival (PFS) results from the GENUINE trial to support the
full approval of TG-1101. The Company plans to have a follow-up
meeting with the FDA to discuss the use of the PFS endpoint in more
detail before the end of the year and also plans to monitor the
regulatory landscape for new approvals of agents for previously
treated high-risk Chronic Lymphocytic Leukemia (CLL) while
continuing to make preparations for a BLA filing as early as
2Q18.
Michael
S. Weiss, Executive Chairman and Chief Executive Officer, stated,
“We had a very productive meeting with the FDA regarding the
GENUINE study and its use for approval of TG-1101 in combination
with ibrutinib. We look forward to our follow-up meeting and
working with the FDA in an effort to reach an agreement on the
potential use of PFS for full approval in a similar timeframe as
accelerated approval.” Mr. Weiss continued, “We were
also pleased to announce today the early completion of UNITY-CLL,
which makes the potential filing timelines for GENUINE and
UNITY-CLL now nearly overlapping, setting the stage for an exciting
2018.”
ABOUT THE PHASE 3 GENUINE TRIAL
The Phase 3 GENUINE study is a randomized, open label, multicenter
clinical trial to evaluate the safety and efficacy of TG-1101
(ublituximab) plus ibrutinib compared to ibrutinib alone in adult
patients with high risk Chronic Lymphocytic Leukemia (CLL) who
received at least one prior therapy for their disease. The study
was conducted at 160 clinical trial sites in the US and Israel and
randomized 126 patients. Patients received ibrutinib orally at 420
mg once daily in both arms and in the treatment arm those patients
also received intravenous infusions of TG-1101 at 900 mg dosed on
days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6. Patients in
the treatment arm who had not progressed received quarterly
infusions of TG-1101 maintenance at 900 mg.
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
(umbralisib), 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, or the
combination of which is referred to as “U2”, are in
Phase 3 clinical development for patients with hematologic
malignancies, with TG-1101 also in Phase 3 clinical development for
Multiple Sclerosis. Additionally, the Company has recently brought
its anti-PD-L1 monoclonal antibody into Phase 1 development and
aims to bring additional pipeline assets into the clinic in the
future. 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 clinical results from the GENUINE
trial or the UNITY-CLL trial may not be sufficient or may not
support regulatory approval of TG-1101 or TGR-1202; the risk that
the company will not be able to deliver data or updates on schedule
as planned; the risk that
a filing based on UNITY-CLL, GENUINE or any other
registration-direct trials cannot be made on schedule as targeted
or at all; the risk that the filing timelines for GENUINE and
UNITY-CLL do not overlap or do not occur at all; the risk that the
company will not file a BLA for TG-1101 based on the GENUINE trial;
the risk that the regulatory landscape for available therapies
changes prior to a potential approval of TG-1101 based on GENUINE
in a way that prevents an accelerated approval; the risk that the
Company and FDA are not able to reach an agreement on the use of
the PFS endpoint for full approval or, if an agreement is reached,
that the PFS results are not positive and supportive of
approval;the risk that safety issues or trends will be observed in
the GENUINE or UNITY-CLL studies that prevent approval; the risk
that the company decides not to use the GENUINE trial results to
seek accelerated approval of TG-1101;the risk that early clinical
trial results, that may have influenced our decision to proceed
with additional clinical trials, will not be reproduced in the
final data. 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
Jenna
Bosco
Vice President -
Investor Relations
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email: ir@tgtxinc.com