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TG Therapeutics, Inc. Announces Pre-Clinical Data Presentation on TGR-1202 at the 2016 American Association for Cancer Research (AACR) Annual Meeting

NEW YORK, March 17, 2016 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (Nasdaq:TGTX) today announced that preclinical data describing the differential regulation of human T-cells by TGR-1202 was selected for poster presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2016, to be held April 16 – 20, 2016 at the Ernest N. Morial Convention Center in New Orleans, Louisiana. The data, which was developed as part of an ongoing research collaboration with the H. Lee Moffitt Cancer Center and Research Institute in Tampa, FL, compares TGR-1202 with the PI3K-delta inhibitors idelalisib and duvelisib in in-vitro models assessing the impact on T-cell subsets.

Michael S. Weiss, the Company's Executive Chairman and Interim Chief Executive Officer, stated, "The recent announcement of the suspension of a number of studies of idelalisib due to toxicity concerns underscores the need for an improved PI3K-delta inhibitor that is not only efficacious, but safe, convenient and tolerable for patients. Many of the adverse events associated with existing PI3K-delta inhibitors such as colitis and hepatic toxicity, and most recently with opportunistic infections, are thought to be related to T-cell immune mediated mechanisms. To date, TGR-1202 has demonstrated what we and many investigators believe to be best-in-class safety and tolerability profile compared to existing PI3K-delta inhibitors. While still early, we are excited about the pre-clinical data that will be presented at AACR and believe it highlights key differences in the impact of PI3k-delta inhibitors on human T-cell subsets, which may begin to potentially explain the differentiated safety profile observed with TGR-1202 to date in the clinic. We look forward to the upcoming poster presentation by the team at Moffitt, and thank them for all their efforts in our ongoing research collaboration.”

The presentation details are as follows:

  • Title: Differential regulation of human T-cells by TGR-1202, a novel PI3Kδ inhibitor
  • Abstract #: 545
  • Presentation Date & Time: Sunday, Apr 17, 2016, 1:00 PM - 5:00 PM
  • Location: Section 26
  • Poster Board Number: 6

A copy of the AACR abstracts were made available yesterday, March 16, 2016 through the AACR meeting website at www.aacr.org. Following the presentation, the poster will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.

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 pre-clinical programs to develop IRAK4 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 possible success of those trials and business prospects for TG-1101, TGR-1202, TG-1303, 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, TG-1303, 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, TG-1303, 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 and TG-1303 will not continue, the risk that TGR-1202 or TG-1303 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current Phase 1 studies; the risk that the combination of 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.

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CONTACT: Jenna Bosco Director- Investor Relations TG Therapeutics, Inc. Telephone: 212.554.4351 Email: ir@tgtxinc.com

Source:TG Therapeutics, Inc.