NEW YORK, June 17, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the presentation of preclinical data for TG-1801, the Company’s first-in-class anti-CD47/CD19 bispecific antibody, highlighting the synergistic effect of TG-1801 in combination with ublituximab, the Company’s anti-CD20 monoclonal antibody and umbralisib, the Company’s PI3K-delta inhibitor. These data were presented over the weekend at the 24th European Hematology Association (EHA) annual congress held in Amsterdam, The Netherlands.

Highlights from this poster presentation include:

Title: The novel bispecific CD47-CD19 antibody TG-1801 potentiates the activity of ublituximab-umbralisib (U2) drug combination in preclinical models of B-NHL

  • TG-1801 is a first-in-class anti-CD47-CD19 bispecific antibody that selectively targets CD47 on CD19+ B-cells, sparing red blood cells and platelets, and blocking the CD47-SIRPα macrophage checkpoint on mature B cells
  • Ublituximab exerts stronger ADCP and ADCC activity in B-NHL cells when compared to rituximab, and TG-1801 increased the ADCC and ADCP activities initiated by both ublituximab and the U2 combination
  • The triple combination of TG-1801 + U2 was found to regulate genes related to cell architecture
  • TG-1801 triggers synergistic tumor growth inhibition and results in prolonged remission when added to U2 in an in vivo Raji lymphoma model, which appears to be mediated by increased infiltration of immune effector cells

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, “TG-1801 is a first-in-class anti-CD47/CD19 bispecific antibody targeting the ‘don’t eat me’ self-defense signal that protects cancer cells from the immune system. This agent is designed to target CD19 expressing cells to avoid off-target CD47 toxicity, representing a novel immunological therapeutic strategy with potential for synergistic or complimentary activity with our current pipeline.” Mr. Weiss continued, “We are excited by the preclinical data presented today for TG-1801. The synergistic effects of TG-1801 in combination with U2 are encouraging and we look forward to evaluating TG-1801 as a single agent in our on-going TG-1801 Phase 1 clinical study and as soon as possible in combination with U2 and our other pipeline drug candidates. TG is committed to improving the outcome of patients with B-cell malignancies through combination therapy and we believe TG-1801 may play an important role in that effort.”

PRESENTATION DETAILS:

The above referenced presentation is available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.

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 multiple therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) 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 umbralisib (TGR-1202), an oral, once-daily inhibitor of PI3K-delta. Umbralisib uniquely inhibits CK1-epsilon, which may allow it to overcome certain tolerability issues associated with first generation PI3K-delta inhibitors. Both ublituximab and umbralisib, or the combination of which is referred to as "U2", are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought into Phase 1 clinical development, TG-1501, its anti-PD-L1 monoclonal antibody, TG-1701, its covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor and TG-1801, its anti-CD47/CD19 bispecific antibody. TG Therapeutics is headquartered in New York City.

Cautionary Statement
Some of the statements included in this press release 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. In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete preclinical and clinical trials of TG-1801; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data analyses from prior preclinical and clinical trials; the risk that TG-1801 may not be safely or effectively combined with other products under development by us or others; 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.

CONTACT:

                Jenna A. Bosco
                Senior Vice President,
                Corporate Communications
                TG Therapeutics, Inc.
                Telephone: 212.554.4351
                Email: ir@tgtxinc.com