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EX-99.2 - EXHIBIT 99.2 - TG THERAPEUTICS, INC. | v120418_ex992.htm |
8-K - 8-K - TG THERAPEUTICS, INC. | v120418_8k.htm |
Exhibit 99.1
TG Therapeutics, Inc. Announces Oral Presentation of Follow-Up Data
from the Triple Combination of Ublituximab, Umbralisib, and
Pembrolizumab in Patients with Relapsed/Refractory CLL and
Richter’s Transformation at 60th American Society of
Hematology Annual Meeting and Exposition
NEW
YORK, NY (December 3, 2018) - TG
Therapeutics, Inc. (NASDAQ: TGTX), today announced updated clinical
data from its Phase I/II 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 pembrolizumab, in
patients with relapsed/refractory Chronic Lymphocytic Leukemia
(CLL) and Richter’s Transformation (RT). Data from this trial
were presented yesterday during an oral 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, “We were excited to share the data presented
from the combination of U2 plus pembrolizumab. Due to potentially
overlapping immune-mediated toxicity, this is the first trial where
a PI3K delta inhibitor has been combined with a PD-1/PD-L1
inhibitor, again highlighting the unique combinability of the U2
regimen. In addition to demonstrating that these drugs could be
safely combined, we were encouraged to see favorable response rates
in both RT and BTK refractory CLL patients, a subset of patients
that are historically challenging to treat.” Mr. Weiss
continued, “Our proprietary anti-PD-L1, TG-1501, has now
completed Phase 1 dose escalation, and we believe the data
presented today set the stage for the commencement of the
combination of U2 plus TG-1501, in the coming
months.”
Below
summarizes the oral presentation.
Phase I/II Study of Umbralisib (TGR-1202) in Combination with
Ublituximab (TG-1101) and Pembrolizumab in Patients with
Relapsed/Refractory CLL and Richter’s Transformation
(Publication Number: 297)
This
oral presentation includes data from patients with relapsed or
refractory CLL or Richter’s Transformation treated with the
triple combination of ublituximab, umbralisib, and pembrolizumab.
Fifteen patients were evaluable for safety (10 CLL patients and 5
RT patients) and 14 were evaluable for efficacy (10 CLL and 4 RT),
with one RT patient too early to evaluate. Data highlights
include:
●
The triple
combination was well tolerated, with immune mediated toxicities not
appearing above what would be expected with either umbralisib or
pembrolizumab alone
●
90% (9 of 10)
Overall Response Rate (ORR) in patients with relapsed/refractory
CLL, including one Complete Response (CR)
●
80% (4 of 5) ORR in
BTK refractory CLL patients, of which 3 of 4 BTK refractory CLL
responders achieved their response to U2 alone prior to
introduction of pembrolizumab
●
50% (2 of 4) ORR in
RT, with both responses being a CR
●
Responses have been
durable, and a median progression-free survival has not yet been
reached
●
The first patient
treated remains progression-free for 36+ months, having now been
off therapy for more than 24 months
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, 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 (TG-1101) and umbralisib (TGR-1202),
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 TG-1501
will not demonstrate acceptable safety or efficacy as either a
single agent or in combination with any other agents; the risk that
a trial evaluating the combination of U2 plus TG-1501 will not
commence. 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
Senior
Vice President,
Corporate
Communications
TG
Therapeutics, Inc.
Telephone:
212.554.4351
Email:
ir@tgtxinc.com