Full Press Release Details
TG Therapeutics, Inc. Announces Long-Term Follow-up of
TGR-1202 Demonstrates a Differentiated Safety Profile and High Response Rates in CLL and NHL in Data Presented at the 52nd
Annual Meeting of the American Society of Clinical Oncology
High response rates observed
across CLL, DLBCL & indolent NHL
Integrated analysis of
165 patients exposed to TGR-1202 monotherapy or the combination of TGR-1202 plus TG-1101 continues to demonstrate a favorable safety
Durations of exposure
upwards of 3+ years with less than 8% of patients having discontinued due to adverse events
Chicago, IL (June 6, 2016) - TG Therapeutics, Inc. (NASDAQ:TGTX)
today announced long term follow-up data of TGR-1202, the Company's once daily PI3K delta inhibitor, both alone and in combination
with TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody. An integrated analysis of
the follow-up data from both studies is being presented today, Monday June 6, 2016 at the 52nd Annual Meeting of the American Society
of Clinical Oncology (ASCO), being held in Chicago, Illinois. The poster is being presented from 8:00am - 11:30am CT, and
will be reviewed during a discussion session from 1:15pm - 2:45pm CT in Room E354b of McCormick Place.
Michael S. Weiss, the Company's Executive Chairman and
Interim CEO commented on the data, "We continue to be impressed with the safety and activity profile of TGR-1202, especially
in combination with TG-1101, together making our proprietary "1303" combination. This data, which includes 3 year follow
up, reinforces our belief that TGR-1202 is a differentiated PI3K delta inhibitor from others in the class. The integrated analysis,
which includes 165 patients treated with TGR-1202 alone or in combination with TG-1101, demonstrates that the toxicities observed
with other PI3K delta inhibitors such as liver toxicity, colitis, pneumonitis and infection are rare with TGR-1202 with discontinuations
due to TGR-1202 related AEs occurring in less than 8% of patients. We see this as particularly compelling given the recent setbacks
for idelalisib with the closure of a series of randomized studies due to safety concerns. The data presented today provides strong
evidence to support the hypothesis that the adverse events seen with idelalisib are not necessarily a class effect." Mr.
Weiss continued, "Not only does TGR-1202 appear to have a best-in-class safety and efficacy profile with the convenience
of once per day dosing, but also demonstrates that a tolerable PI3K delta inhibitor can induce long-term responses in patients
with CLL rivaling BTK inhibitors. However, unlike BTK inhibitors, whose activity has been primarily limited to CLL and MCL, TGR-1202
has also demonstrated significant activity in the larger indications of Follicular Lymphoma and DLBCL. Our UNITY program is designed
to highlight the breadth of utility of TG-1303 across a wide range of B-cell malignancies, starting with CLL, and now moving into
DLBCL and iNHL to follow soon, and we believe its high level of activity, tolerability and ease of administration will make TG-1303
an important new treatment option for these patients.
The poster, entitled "Long-term
follow-up of the PI3K delta inhibitor TGR-1202 demonstrates a differentiated safety profile and high response rates in CLL and
NHL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab" (Abstract Number: 7512), includes data from
165 patients with relapsed or refractory hematologic malignancies, 90 of which were treated with TGR-1202 and 75 of which
were treated with TGR-1202 in combination with TG-1101. Patients were heavily pretreated, with the majority of patients having
seen 3 or more prior lines of therapy and 52% (85/165) of patients being refractory to their immediate prior therapy.
Highlights from the poster include:
Safety and Tolerability:
A copy of the poster presentation is available on the Company's
website at www.tgtherapeutics.com, located on the Publications Page, within the Pipeline
TG THERAPEUTICS INVESTOR & ANALYST EVENT DETAILS
TG Therapeutics will also host a reception this evening, Monday,
June 6, 2016 beginning at 7:00pm CT, with featured presentations beginning promptly at 7:10pm CT. The event will take place at
the Peninsula Chicago Hotel in the Avenues Ballroom. 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 June
2016 Investor & Analyst Event.
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, 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 recently entering 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, 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, the BET 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, the BET 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, the BET 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.
Vice President- Investor Relations
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: ir@tgtxinc.com