Full Press Release Details
TG Therapeutics, Inc. Announces Data Presentations at the
57th American Society of Hematology Annual Meeting From Ongoing Clinical Studies in Patients with Non-Hodgkins Lymphoma
(NHL) and Chronic Lymphocytic Leukemia (CLL)
Combination of TG-1101 plus TGR-1202 ("TG-1303")
continues to demonstrate a favorable safety profile, with only 8% of patients discontinuing due to an adverse event and no cases
of colitis reported to date
80% (8 of 10) ORR in patients with relapsed refractory CLL/SLL
treated in the higher dose cohort of TG-1303, including 1 CR and 7 PR's and the remaining 2 patients with stable disease,
one still on study with significant reduction in tumor burden (CLL evaluated per iwCLL 2008 criteria)
71% (12 of 17) ORR, including 24% CRs, in patients with heavily
pretreated relapsed/refractory Follicular Lymphoma (FL) & Marginal Zone Lymphoma (MZL) treated in the higher dose cohort of
35% (6 of 17) ORR in patients with relapsed/refractory DLBCL
and Richter's transformation (large cell lymphoma) treated in the higher dose cohort of TG-1303
TGR-1202 based combination therapy with the glycoengineered
anti-CD20 mAb, obinutuzumab, plus chlorambucil achieved 100% (15 of 15) ORR in treatment na ve CLL patients, with 33% of patients
achieving a CR, and 47% of patients achieving MRD negativity
ORLANDO, FL, December 6, 2015-- TG Therapeutics, Inc. (Nasdaq:TGTX),
today announced updated clinical results from its ongoing Phase I proprietary combination study of TG-1101 (ublituximab), the Company's
novel, glycoengineered monoclonal antibody and TGR-1202, the Company's oral, once-daily, PI3K delta inhibitor as well as data from
the Phase I study of TGR-1202 in combination with obinutuzumab plus chlorambucil. Data from these Phase I studies were presented
this weekend at poster sessions during the 57th American Society of Hematology (ASH) Annual Meeting and Exposition being held at
the Orange County Convention Center in Orlando, FL.
Michael S. Weiss, the Company's Executive Chairman and
Interim CEO commented on the data, "We and our clinical investigators continue to be impressed with the activity and safety
profile of our proprietary TG-1303 regimen with almost all CLL patients responding and over 70% of heavily pre-treated patients
with indolent lymphoma responding to 1303. We are also very excited by the data in patients with large cell lymphoma where we are
seeing 35% response rates in heavily pre-treated patients. Collectively, we believe these data support advanced clinical studies
for TG-1303 across CLL and NHL and, accordingly, we plan to expand our UNITY clinical program into NHL in 2016. Finally, we are
excited to see the high level of activity of a TGR-1202 based regimen in front-line CLL. We believe the safety and efficacy profile
observed in those front-line patients sets the stage for what we should expect to see from TG-1303 in front-line patients included
in our UNITY-CLL Phase 3 trial, which should open for enrollment in the coming weeks." Mr. Weiss continued, "We appreciate
the strong support of our clinical investigators and thank them and their patients for participating in these important clinical
Dr. Matthew Lunning, Assistant Professor, Division of Hematology
at the University of Nebraska Medical Center and lead author for the poster presentation stated, "The principal goal for
any novel-novel combination study is to establish safety and combinability of two agents. With the combination of ublituximab and
TGR-1202, patients were not only able to achieve high response rates and durable remissions, but most importantly, were able to
stay on treatment with limited discontinuations due to adverse events, which has been commonly seen with other novel targeted agents
in this class. Many of the patients enrolled onto this study have been heavily pre-treated with limited treatment options, especially
patients with DLBCL, and the ability to offer patients a novel-novel combination which has the potential to extend and improve
patient lives is of great excitement."
The following summarizes the posters presented this weekend:
Ublituximab + TGR-1202 Demonstrates Activity and Favorable
Safety Profile in Relapsed/Refractory B-Cell NHL and High-Risk CLL: Phase I Results (Abstract Number 1538)
This poster was presented yesterday, Saturday December 5th
during the ASH Annual Meeting and included data from patients with relapsed and refractory NHL and high-risk CLL treated with the
combination of TG-1101 (ublituximab) and TGR-1202. The combination has been well tolerated in the 71 patients evaluable for safety
at all dose levels up through 1200mg micronized. This was a heavily pretreated population with high-risk features, including 58%
refractory to last treatment with multiple previous lines of rituximab based therapy. Efficacy data was presented on patients treated
at the higher doses of TGR-1202 (1200mg of the original formulation and 600mg or greater of the micronized formulation).
Highlights from this poster include:
A Phase I Trial of TGR-1202, a Next Generation Once Daily
PI3K-Delta Inhibitor in Combination with Obinutuzumab Plus Chlorambucil, in Patients with Chronic Lymphocytic Leukemia (Abstract
The poster was presented today, Sunday December 6th
during the ASH Annual Meeting and includes data from patients with treatment na ve and previously treated CLL treated with
TGR-1202 in combination with the glycoengineered anti-CD20 mAb, obinutuzumab, and chlorambucil. The study design evaluated escalating
doses of TGR-1202 which was dosed orally once-daily starting at Day 1 of Cycle 1. Obinutuzumab and chlorambucil were administered
according to their FDA labeled dosing regimen. The combination was dosed in 18 patients, of which 15 were treatment na ve
and 3 were previously treated. All patients were evaluable for safety and efficacy.
Highlights from this poster include:
A copy of the poster presentations
are available on the Company's website at www.tgtherapeutics.com, located on the
Publications Page, within the Pipeline section.
TG THERAPEUTICS INVESTOR & ANALYST EVENT DETAILS
TG Therapeutics will also host a reception on Monday, December
7th, 2015 beginning at 7:45pm ET, with featured presentations beginning promptly at 8:00pm ET. The event will take place
at the Hyatt Regency Orlando in the Bayhill 17/18 Room. This event will be webcast live and will be available on the Events page,
located within the Investors & Media section of the Company's website at www.tgtherapeutics.com, as well as archived
for future review. This event will also be broadcast via conference call. In order to access the conference line, please
call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG Therapeutics 2015 Investor &
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. 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, 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. The Company also has a pre-clinical program to develop
IRAK4 inhibitors, as well as an antibody research program to develop anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered
Cautionary Statement
Some of the statements included in this press release, particularly
those with respect to anticipating future clinical trials, the timing of commencing or completing such trials and business prospects
for TG-1101, TGR-1202, the IRAK4 inhibitor program, and the anti-PD-L1 and anti-GITR antibodies 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 pre-clinical and clinical trials
for TG-1101, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies; the risk that early pre-clinical
and clinical results that supported our decision to move forward with TG-1101, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1
and anti-GITR antibodies will not be reproduced in additional patients or in future studies; the risk that trends observed which
underlie certain assumptions of future performance of TGR-1202 will not continue, the risk that TGR-1202 will not produce satisfactory
safety and efficacy results to warrant further development following the completion of the current Phase 1 study; the risk that
the combination of TG-1101 and TGR-1202, referred to as TG-1303, will not prove to be a safe and efficacious backbone for triple
and quad combination therapies; the risk that the data (both safety and efficacy) from future clinical trials will not coincide
with the data produced from prior pre-clinical and clinical trials; the risk that trials will take longer to enroll than expected;
our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections,
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 |
| Director- Investor Relations | |
| TG Therapeutics, Inc. | |
| Telephone: 212.554.4351 | |
| Email: ir@tgtxinc.com |