April 4, 2017

TG Therapeutics, Inc. Announces Preclinical Data Presentation on the Company's Anti-PD-L1 Monoclonal Antibody at the American Association for Cancer Research Annual Meeting

First-in-human trial expected to launch in 2017

NEW YORK, April 04, 2017 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX), today announced the first presentation of preclinical data on the Company's novel fully human anti-PD-L1 monoclonal antibody at the American Association for Cancer Research (AACR) annual meeting, being held this week, April 1-5, 2017, at the Walter E. Washington Convention Center in Washington, D.C.

The following poster was presented today, April 4, 2017, during the Immunoconjugates and Antibodies Session in Halls A-C.

Preclinical Characterization of a Novel Fully Human lgG1 Anti-PD-L1 mAb CK-301

Based on the various assays performed, the poster concluded:

  • CK-301 is a high affinity PD-L1 specific fully humanized lgG1 antibody which blocks binding of PD-L1 to PD-1.
  • Activity of CK-301 in all assays tested was similar to anti-PD-L1's used as active controls (surrogates of avelumab, atezolizumab, or durvalumab).
  • Similar to the approved anti-PD-L1, avelumab, CK-301 has the potential to induce ADCC (antibody-dependent cell-mediated cytotoxicity).

A first-in-human Phase 1 study of CK-301 is planned to commence this year.

Michael S. Weiss, the Company's Executive Chairman and Chief Executive Officer stated, "The team has worked hard to develop a high quality anti-PD-L1 antibody which we believe is the cornerstone of any proprietary immune-oncology (I/O) strategy.  While anti-PD-1/PD-L1 therapy has been broadly explored in solid tumors, we are still in the very early days of understanding their utility and best applications in B-cell malignancies.   As a company, we have been highly focused on developing best-in-class combination therapies for patients with B-cell malignancies and believe the next generation of combinations will include both targeted therapies, like TG-1101 and TGR-1202, plus I/O agents like our anti-PD-L1 antibody presented here today.  We look forward to commencing the first-in-human study this year."

PRESENTATION DETAILS

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

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 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, particularly those anticipating future clinical trials, timing of clinical trials for anti-PD-L1 antibodies and business prospects and potential uses for anti-PD-L1 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 identify anti-PD-L1 antibodies suitable for clinical development, our ability to successfully and cost-effectively complete pre-clinical and clinical trials for anti-PD-L1 antibodies; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data analyses from prior pre-clinical and clinical trials; 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

Vice President, Investor Relations

TG Therapeutics, Inc.

Telephone: 212.554.4351

Email: ir@tgtxinc.com

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Source: TG Therapeutics, Inc.

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