August 24, 2012

TG Therapeutics, Inc. Announces Poster Presentation for Ublituximab (TGTX-1101) at the 7th International Workshop on Waldenstrom's Macroglobulinemia

Ublituximab Demonstrates Greater Antibody-Dependent Cellular Cytotoxicity (ADCC) Than Rituximab (Rituxan(R)) in Waldenstrom's Macroglobulinemia Patient Blood Samples

NEW YORK, Aug. 24, 2012 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (OTCBB:TGTX) today announced a poster presentation at the 7th International Workshop on Waldenström's Macroglobulinemia (WM), held in Newport, RI. The poster entitled "Role of NK-mediated ADCC in Waldenström's Macroglobulinemia Patients: Evidence Supporting a Therapeutic Strategy" was presented by Professor Veronique Leblond, MD, PhD, Head of Hematology, Hospital Pitié-Salpêtrière, Paris, France. Ublituximab, a novel, third generation chimeric monoclonal antibody targeting a unique epitope on the CD20 antigen, has been bioengineered for enhanced biological activity with an increased ability to trigger an immune response, delivering superior ADCC effects to aid in B-cell depletion.

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Anti-CD20 monoclonal antibodies have several potential mechanisms of action, including ADCC which involves recruitment of effector cells such as Natural Killer (NK) cells to deplete circulating B-lymphocytes. This study evaluated the ADCC recruitment of NK cells in the presence of ublituximab in comparison to rituximab. Data presented at the meeting demonstrated that ublituximab is more efficient than rituximab in inducing ADCC at low doses and more importantly, results suggest that ublituximab could be more efficient than rituximab both to induce NK cell degranulation and ADCC in the presence of autologous peripheral tumor cells.

"Anti-CD20 monoclonal antibody therapy is a critical treatment component in WM; however patients continue to relapse. This data highlights the excitement for ublituximab, a new optimized anti-CD20 monoclonal antibody in the treatment of WM," stated Professor Leblond.


Ublituximab is a novel, third generation chimeric monoclonal antibody targeting a unique epitope on the CD20 antigen found on B lymphocytes. Ublituximab has been bioengineered for enhanced biological activity with an increased ability to trigger an immune response, delivering superior ADCC effects to aid in B-cell depletion.  Ublituximab has displayed high single agent activity in a Phase I/II clinical trial in patients with relapsed Chronic Lymphocytic Leukemia, and is being developed by TG Therapeutics in multiple oncology and autoimmune indications. A Phase I/II clinical trial of ublituximab in patients with non-Hodgkin's lymphoma, relapsed or refractory to prior anti-CD20 therapy, is currently ongoing. 

Ublituximab has been granted orphan status in Europe and in the USA for B-cell Chronic Lymphocytic Leukemia.


TG Therapeutics is an innovative, clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of innovative and medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs. Currently, the company is developing two advanced therapies targeting hematological malignancies. TGTX-1101 (ublituximab) is a novel, third generation monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes, currently in clinical development for patients with relapsed and refractory non-Hodgkin's lymphoma. TG Therapeutics is also developing TGR-1202, a highly specific, 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‐cell lymphocytes. TG Therapeutics is headquartered in New York City. 

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Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for ublituximab 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 ublituximab; 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 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: 212.554.4484


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Source: TG Therapeutics, Inc.

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