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EX-99.1 - EXHIBIT 99.1 - TG THERAPEUTICS, INC. | v061417_ex991.htm |
EX-99.3 - EXHIBIT 99.3 - TG THERAPEUTICS, INC. | v061617_ex993.htm |
8-K - 8-K - TG THERAPEUTICS, INC. | v061617_8k.htm |
TG Therapeutics, Inc. Announces
Follow-Up Data from the Triple Combination of TG-1101, TGR-1202,
and Bendamustine in Patients with DLBCL and FL at the
14th
International Conference on Malignant
Lymphoma
100% (4 of 4) ORR, including 50% CR rate in patients with relapsed
Diffuse Large B-Cell Lymphoma (DLBCL)
50% (6 of 12) ORR, including 42% CR rate in patients with chemo
and/or SCT refractory DLBCL
88% (7 of 8) ORR, including 50% CR rate in patients with relapsed
or refractory Follicular Lymphoma (FL)
The triple combination of TG-1101, TGR-1202 and bendamustine was
generally well-tolerated with the only Gr 3/4 event >10% being
neutropenia
NEW YORK, June 15, 2017-- TG Therapeutics, Inc. (NASDAQ: TGTX),
today announced updated clinical data from its Phase I/Ib trial of
TG-1101 (ublituximab), the Company’s novel glycoengineered
anti-CD20 monoclonal antibody in combination with TGR-1202
(umbralisib), 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 today during a poster session at the
14th
International Conference on Malignant
Lymphoma (ICML).
Michael S. Weiss, the Company's Executive Chairman and Chief
Executive Officer stated, “Relapsed and refractory DLBCL
remains one of the most difficult to treat lymphoid malignancies,
with a uniformly poor prognosis, particularly for patients with
refractory disease who are not eligible for high-dose chemotherapy
or stem-cell transplantation.” Mr. Weiss continued,
“The data presented today by Dr. Lunning supports our belief
that the combination of TG-1101 (ublituximab) and TGR-1202
(umbralisib), our ‘U2 regimen’, with bendamustine is a
highly active and well tolerated treatment for patients with
aggressive lymphomas. We are excited to be able to rapidly bring
this combination forward in the DLBCL arm of our randomized
registration-directed UNITY-NHL program and hope to be enrolling
patients into this cohort before the end of the
summer.”
Dr. Matthew Lunning, of the University of Nebraska Medical Center,
stated, “I am extremely pleased with the durable responses
seen with this novel triplet regimen, especially in patients with
aggressive DLBCL who may not have been candidates for more
intensive chemotherapy, transplantation, or CAR-T therapy, due to
poor performance status or need for urgent therapy, a truly unmet
medical need. Many patients had high-risk molecular features
and some have obtained sustained responses. In addition to
being highly active, the triplet regimen of U2-benda was very well
tolerated, with a low incidence of Grade 3 or greater adverse
events, particularly those that have been associated with the
PI3K-delta class. I look forward to the possibility of
testing this regimen earlier in relapsed and refractory DLBCL and
am excited to see it advance into registration directed
studies.”
Highlights from today’s presentation include the
following:
Poster
Presentation: Combination of
TGR-1202, Ublituximab, and Bendamustine is safe and highly active
in patients with advanced DLBCL and Follicular Lymphoma (Abstract
277)
This
poster presentation includes data from patients with relapsed or
refractory Diffuse Large B-Cell Lymphoma (DLBCL) or Follicular
Lymphoma (FL) treated with the triple combination of TG-1101
(ublituximab), TGR-1202 (umbralisib) and bendamustine. Thirty-three
patients were evaluable for safety of which 24 were evaluable for
efficacy (9 patients were note evaluable; 7 were too early to
evaluate and 2 patients were off study prior to an efficacy
assessment: 1 non-related adverse event (AE) and 1 investigator
decision). The triple combination appears well tolerated with no
discontinuations for a treatment related AE. No events of
pneumonitis and no Grade 3/4 transaminitis were reported.
Twenty-one patients (64%) were refractory to prior treatment. Mean
time on study was approximately 6 months.
Efficacy highlights from this poster include:
●
100%
(4 of 4) ORR, including a 50% CR rate, observed in patients with
relapsed DLBCL
●
50%
(6 of 12) ORR, including a 42% CR rate, observed in patients with
refractory DLBCL with durable CR and PR responses observed (PR
on-going for >16+ months)
●
88%
(7 of 8) ORR, including a 50% CR rate, observed in patients with
relapsed or refractory FL
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. 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 are in clinical development for patients with hematologic
malignancies, with TG-1101 also in clinical development for
autoimmune disorders. The Company also has pre-clinical programs to
develop IRAK4 inhibitors, BET inhibitors, and anti-PD-L1
and anti-GITR antibodies. 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 clinical trials; the risk that early clinical trial
results, including the safety and efficacy results seen with the
combination of TG-1101, 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; the risk that the combination of
TG-1101 and TGR-1202, referred to as TG-1303 or as
“U2”, and being studied in the triple combination of
TG-1101 plus TGR-1202 plus bendamustine and in the UNITY clinical
trials and other combination trials, will not prove to be safe and
efficacious for any indication or as a backbone for current or
future triple and/or quad therapies. 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
CONTACT:
Jenna
Bosco
Vice President,
Investor Relations
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email: ir@tgtxinc.com