Full Press Release Details
TG Therapeutics, Inc. Announces Clinical and Preclinical Data
Presentations at the 23rd Congress of the
European Hematology Association
YORK, NY (June 15, 2018) - TG Therapeutics, Inc. (NASDAQ: TGTX),
today announced the presentation of an integrated analysis of long
term safety data of umbralisib (TGR-1202), the Company's PI3K
delta inhibitor, either dosed as a single agent and in combination,
in patients with relapsed or refractory lymphoid malignancies, as
well as the first preclinical data presentation of TG-1701, the
Company's orally available and covalently-bound BTK
inhibitor. Data from these trials are being presented today during
Congress of the European Hematology Association (EHA).
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, We are extremely pleased to present updated
data from our integrated safety analyses of umbralisib. There is a
generally held belief that severe toxicities are more common
following 6 months of exposure on a PI3K delta inhibitor. While
this has held true for first generation delta inhibitors, we are
pleased to present data from 177 patients on daily umbralisib for
more than 6 months, ranging upwards of 5+ years, and believe the
long-term follow-up data demonstrates that umbralisib has a
differentiated safety profile, uniquely distinct from prior
generation PI3K delta inhibitors. Mr. Weiss continued,
The differentiated safety profile of umbralisib is critical
as we think about potential triple and quad combination strategies,
especially in combination with our novel, proprietary BTK
inhibitor, TG-1701, for which we also presented some exciting
pre-clinical data. The kinase profile of TG-1701 looks quite
competitive with the most specific BTK inhibitors and more
selective than ibrutinib. We look forward to seeing more data on
TG-1701 and expect to open a TG sponsored Phase 1/2 trial later
from today's presentations include the
Presentation: Long term integrated safety analysis of
umbralisib (TGR-1202), a PI3K delta/CK1-epsilon inhibitor with a
differentiated safety profile in patients with relapsed/refractory
lymphoid malignancies
This presentation builds on a prior integrated analysis of 347
patients with relapsed or refractory lymphoid malignancies
presented last year. The presentation includes data that were
pooled from 4 completed or ongoing Phase 1 or 2 studies containing
umbralisib, focusing on 177 patients who have been on daily
umbralisib for a minimum of 6 months. Patients were heavily
pretreated, with 45% of patients having seen 3 or more prior lines
Highlights from this poster include:
continues to exhibit a differentiated safety profile compared to
prior generation PI3K delta inhibitors
patients have been treated with daily umbralisib for 6+ months,
with a median duration of exposure of 1.3 years, and 33% patients
on drug 2+ years and the longest patients on daily umbralisib for
adverse events occurring in >1% of patients were limited to
pneumonia (3%), diarrhea (2%), and cellulitis (2%)
2% of patients discontinued as a result of diarrhea/colitis after
being on umbralisib for more than 6 months
due to other adverse events (AEs) of interest for prior generation
PI3K inhibitors were also rare
Poster Presentation: TG-1701 is a novel, orally
available, and covalently-bound BTK inhibitor
specific and covalent BTK inhibitor, is more selective than
ibrutinib toward a set of kinases
assays in vitro and in vivo suggest that 100% occupancy can be
reached using low doses of TG-1701 in human dose escalation
experiments, TG-1701 inhibited the phosphorylation of BTK and other
kinases downstream of the BCR pathway.
animal models of b-cell malignancies, TG-1701 demonstrated similar
antitumor efficacy to ibrutinib and acalabrutinib
PRESENTATION DETAILS
above referenced presentations are 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
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