Untitled Document
TG Therapeutics, Inc.
Announces Follow-Up Data from the
Triple Combination of Ublituximab, Umbralisib, and Bendamustine in
Patients with DLBCL and FL at 60th
American Society of Hematology
Annual Meeting and Exposition
NEW YORK, December 4, 2018 -- TG Therapeutics, Inc. (NASDAQ: TGTX), today
announced updated clinical data from its Phase I/Ib trial of
ublituximab (TG-1101), the Company’s novel glycoengineered
anti-CD20 monoclonal antibody in combination with umbralisib
(TGR-1202), the Company’s oral, next generation PI3K delta
inhibitor, and bendamustine, in patients with Diffuse Large B-cell
Lymphoma (DLBCL) and Follicular Lymphoma (FL). Data from this trial
was presented yesterday evening during a poster session at the
60th
American Society of Hematology (ASH)
Annual Meeting and Exposition.
Michael
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer stated, “The data presented yesterday further
supports our belief that our proprietary U2 combination is an ideal
backbone regimen on which to build novel multi-drug combinations.
The triple therapy of U2 plus bendamustine is highly active and
well tolerated in advanced patients, resulting in durable responses
with some patients on study 36+ months.” Mr. Weiss continued,
“We are looking forward to an exciting 2019, with pivotal
data expected from the ongoing UNITY-NHL registration directed
program in the first half of the year.”
Below summarizes the data from the poster
presentation.
Combination of Umbralisib, Ublituximab, and Bendamustine is Safe
and Highly Active in Patients with Advanced DLBCL and Follicular
Lymphoma (Abstract 4197)
This
poster presentation includes data from patients with relapsed or
refractory DLBCL or FL treated with the triple combination of
umbralisib, ublituximab and bendamustine. Thirty-nine patients were
evaluable for safety of which 38 were evaluable for efficacy (one
patient discontinued due to a treatment-related adverse event (AE),
neutropenia, prior to first efficacy assessment). Twenty-two
patients (56%) were refractory to prior treatment. Overall, the
triple combination was well tolerated and highly active in patients
with advanced indolent and aggressive NHL, including those not
eligible for HD/SCT or CD19 CART therapy.
Efficacy highlights from this poster include:
●
85%
(11 of 13) ORR, including a 54% CR rate, observed in patients with
relapsed or refractory FL
●
48%
(12 of 25) ORR, including a 36% CR rate, observed in patients with
relapsed or refractory DLBCL
PRESENTATION DETAILS:
The
above referenced presentation is 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, TG-1501, as well as its
covalently-bound Bruton Tyrosine Kinase (BTK) inhibitor, TG-1701,
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:
our ability to successfully and cost effectively complete
preclinical and clinical trials; the risk that the highlighted
early clinical trial results, including the safety and efficacy results seen
with the combination of ublituximab (TG-1101), umbralisib
(TGR-1202) plus bendamustine 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
combination of ublituximab and umbralisib, referred to as U2 and
being studied in the UNITY clinical trials, will not prove to be a
safe and efficacious combination, or backbone for triple therapy
combinations; the risk that data from the UNITY-NHL trial will not
be delivered on time or as planned. 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
Corporate
Communications