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EX-99.2 - EXHIBIT 99.1 - TG THERAPEUTICS, INC. | v061818_ex992.htm |
8-K - 8-K - TG THERAPEUTICS, INC. | v061818_8k.htm |
Exhibit
99.1
TG Therapeutics, Inc. Presents Phase 2 Data Evaluating Umbralisib
in CLL Patients Intolerant to Prior BTK or PI3K Delta Inhibitor
Therapy at the 23rd Congress of the
European Hematology Association (EHA)
NEW
YORK NY (June 18, 2018) - TG Therapeutics, Inc. (NASDAQ: TGTX),
today announced an oral presentation of clinical data from its
ongoing Phase 2 study evaluating umbralisib (TGR-1202), the
Company’s PI3K delta inhibitor, in patients with relapsed or
refractory Chronic Lymphocytic Leukemia (CLL) who are intolerant to
prior BTK or PI3K delta inhibitor therapy. Data from this trial
were presented over the weekend during an oral session at the 23rd Congress of the
European Hematology Association (EHA).
Michael
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, “We are pleased to present data evaluating
umbralisib in patients intolerant to currently approved BTK or PI3K
therapies during the EHA annual congress. While there have been
great advancements in recent years in the treatment of CLL, this
study confirms that there are many patients still in need of an
alternative treatment option and that umbralisib can be used safely
and effectively in those patients who were not able to tolerate a
prior BTK or PI3K therapy. The rate of patients withdrawing from
kinase treatment for CLL in real world settings has been estimated
to reach upwards of 40%, representing a significant unmet medical
need.” Mr. Weiss continued, “We are extremely pleased
with the data presented at ASCO and EHA this month and we look
forward to presenting the topline response rate data from the
UNITY- CLL Phase 3 trial by the end of summer
2018.”
Highlights
from the oral presentation include the following:
Oral Presentation:
A Phase 2 Study to Assess the Safety and Efficacy of Umbralisib
(TGR-1202) In Patients with Chronic Lymphocytic Leukemia (CLL) Who
Are Intolerant to Prior BTK or PI3K-delta Inhibitor Therapy
(Abstract Number S808)
This
presentation includes data from patients with CLL who are
intolerant to prior BTK or PI3K delta inhibitor therapy who were
then treated with single agent umbralisib (TGR-1202). To be
eligible for the study patients had to have received prior
treatment with a BTK inhibitor (ibrutinib, acalabrutinib) or a PI3K
delta inhibitor (idelalisib, duvelisib) and discontinued therapy
due to intolerance within 12 months of starting treatment on this
study. Forty-seven patients were evaluable for safety of which 46
were evaluable for Progression Free Survival (PFS), (1 patient had
a confirmed Richter’s Transformation (RT) at enrollment which
did not meet eligibility criteria).
Highlights
from this presentation include:
●
Umbralisib
demonstrated a favorable safety profile in patients intolerant to
prior BTK or PI3K therapy
●
Only 13%
discontinued due to an adverse event, of which only one patient
discontinued due to a recurrent adverse event (AE) also experienced
with prior kinase inhibitor therapy
●
Median progression
free survival (PFS) and overall survival has not been reached with
a median follow-up of 9.5 months
●
In this
relapsed/refractory CLL population, of which 77% required treatment
within 6 months of prior KI discontinuation, 64% had a high-risk
molecular / genetic marker and 6% had an ibrutinib resistance
mutation, significant clinical activity has been
observed
PRESENTATION DETAILS
The
above referenced presentation is now available on the Publications
page, located within the Pipeline section, of the Company’s
website at www.tgtherapeutics.com/publications.cfm.
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 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 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 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 or in the
abstracts mentioned 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. 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; the risk that
early clinical trial results (both safety and efficacy), 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 differentiated tolerability
profile for umbralisib observed will not be reproduced in full
presentations or later larger studies; the risk that the final data
from either GENUINE or UNITY-CLL will not support a regulatory
filing or approval or that the company will choose not to file a
BLA/NDA or seek accelerated approval based on those studies; the
risk that the topline overall response rate data from the UNITY-CLL
trial is not be statistically significant 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.
CONTACT:
Jenna
Bosco
SVP,
Corporate Communications
TG
Therapeutics, Inc.
Telephone:
212.554.4351
Email:
ir@tgtxinc.com