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Nov 01, 2018

TG Therapeutics, Inc. Announces Triple Therapy Data Presentations at the Upcoming 60th American Society of Hematology Annual Meeting and Exposition

Investor and Analyst Event to be Held on Sunday December 2, 2018 at 7:30 PM PT at the Marriot Gaslamp San Diego with Presentations by Leading Clinical Investigators

NEW YORK, Nov. 01, 2018 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that updated data for umbralisib (TGR-1202), the Company’s once-daily PI3K delta inhibitor, and ublituximab (TG-1101), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, have been selected for presentation at the upcoming 60thAmerican Society of Hematology (ASH) annual meeting and exposition, to be held December 1-4, 2018, at the San Diego Convention Center in California. Abstracts are now available online and can be accessed on the ASH meeting website at www.hematology.org. Abstract highlights and presentation details are outlined below.

Abstract Highlights:

  • Umbralisib + Ublituximab + Pembrolizumab Triple Therapy Oral Presentation:
    • 89% ORR (8 of 9) observed in relapsed or refractory Chronic Lymphocytic Leukemia (CLL) patients with 75% ORR (3 of 4) in BTK refractory CLL patients
      • Notably 2 of 4 BTK-refractory CLL patients achieved a response to umbralisib plus ublituximab (“U2”) alone, prior to the addition of pembrolizumab
    • 50% ORR (2 of 4) observed in patients with Richter’s Transformation (RT)
      • Both responders were ibrutinib refractory and achieved durable Complete Responses (CRs) (time on therapy 15+ months and 7+ months)

  • Umbralisib + Ublituximab + Bendamustine Triple Therapy Poster Presentation:  
    • 85% ORR (11 of 13) observed in relapsed or refractory Follicular Lymphoma (FL) patients, including 54% CRs
    • 48% ORR (12 of 25) observed in relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) patients, including 32% CRs

Oral Presentation Details:

  • Title: Phase I/II Study of Umbralisib (TGR-1202) in Combination with Ublituximab (TG-1101) and Pembrolizumab in Patients with Relapsed/Refractory CLL and Richter’s Transformation
    • Publication Number: 297
    • Oral Session: 642. CLL: Therapy, excluding Transplantation: Cellular Therapy and Immunomodulation in CLL
    • Session Date and Time:  Sunday, December 2, 2018; 7:30 AM - 9:00 AM PT
      • Presentation Time: 8:00 AM PT
    • Location: Marriott Marquis San Diego Marina, Pacific Ballroom 20
    • Presenter: Anthony R. Mato, MD, Memorial Sloan-Kettering Cancer Center, New York, NY

Poster Presentation Details:

  • Title: Combination of Umbralisib, Ublituximab, and Bendamustine Is Safe and Highly Active in Patients with Advanced Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
    • Abstract Number: 4197
    • Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster III
    • Date and Time:  Monday, December 3, 2018; 6:00 PM - 8:00 PM PT
    • Location: San Diego Convention Center, Hall GH
    • Presenter: Matthew A. Lunning, DO, University of Nebraska Medical Center, Omaha, NE

Following each presentation, the data presented will be available on the Publications page of the Company’s website at http://tgtxinc.com/publications.cfm.

TG THERAPEUTICS INVESTOR & ANALYST EVENT

TG Therapeutics will also host a reception on Sunday, December 2, 2018 beginning at 7:30 PM PT with featured presentations beginning promptly at 8:00 PM PT. The event will take place at the Marriott Gaslamp in San Diego California. The event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at http://ir.tgtherapeutics.com/events, as well as archived for future review. This event will also be broadcast via conference call. To access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG TherapeuticsDecember 2018 Investor & Analyst Event. 

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. 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 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 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 its anti-PD-L1 monoclonal antibody into Phase 1 development and aims to bring additional pipeline assets into the clinic in the future. 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; the risk that the highlighted early clinical trial results, that may have supported the acceptance of our data for presentation or influenced our decision to proceed with additional clinical trials, will not be reproduced in future studies or in the final presentations; the risk that the combination of ublituximab (TG-1101) and umbralisib (TGR-1202), referred to as U2 and being studied in the UNITY clinical trials, will not prove to be a safe and efficacious combination, or backbone for triple therapy combinations. 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 Bosco
Senior Vice President,
Corporate Communications
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: ir@tgtxinc.com

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Source: TG Therapeutics, Inc.