TG Therapeutics, Inc. Announces Pre-Clinical Data Presentation on TGR-1202 Demonstrating Differentiated Effects on T-Cells

Poster Presentation at the American Association for Cancer Research (AACR) Annual Meeting 2016 compares TGR-1202 to other PI3K-delta inhibitors, providing preliminary mechanism for differentiated clinical safety observed to date

NEW YORK, April 18, 2016 -- TG Therapeutics, Inc. (Nasdaq:TGTX) today announced the presentation of preclinical data describing the differential regulation of human T-cells by TGR-1202 in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2016, which is being held April 16 – 20, 2016 at the Ernest N. Morial Convention Center in New Orleans, Louisiana.  

As part of an ongoing research collaboration with the H. Lee Moffitt Cancer Center and Research Institute in Tampa, FL, data was generated comparing TGR-1202 with the PI3K-delta inhibitors idelalisib and duvelisib in in-vitro models assessing the impact on T-cell subsets.  Key conclusions from the poster are as follows:

• TGR-1202 exhibits dose dependent cytotoxicity against human T cells beginning 25uM, comparable to the PI3K-delta inhibitors idelalisib and duvelisib,
• TGR-1202 allows relative conservation of TH2 cytokine expression and GATA-3 mRNA compared to other PI3K-delta inhibitors idelalisib and duvelisib
• Regulatory T cell (Treg) population number and function is reduced overall after treatment with all three agents but to a lesser degree in TGR-1202 treated samples
• TGR-1202 does not robustly reduce the expression of PD-1 and CTLA-4 on Tregs, suggesting that a suppressive phenotype is maintained to a greater extent compared to idelalisib and duvelisib.

Michael S. Weiss, the Company's Executive Chairman and Interim Chief Executive Officer, stated, "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.  This pre-clinical data now begins to elucidate key differences in the impact of these inhibitors on human T-cell subsets, which may explain the differentiated safety profile observed with TGR-1202 to date in the clinic.  These data represent the first step in improving our understanding and we look forward to continuing our research collaboration with the team at Moffitt.”  

PRESENTATION DETAILS

A copy of the poster is available on the Company's website at www.tgtherapeutics.com, located on the Publications Page, within the Pipeline section.

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.

TGTX - G

CONTACT:

Jenna Bosco
Director- Investor Relations
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: [email protected]