Combination of TG-1101, the Company's Novel Glycoenginereed Anti-CD20 Monoclonal Antibody and TGR-1202, the Company's Once Daily PI3K Delta Inhibitor to be Highlighted in Oral Presentation
Updates on the Combination of TG-1101 Plus Ibrutinib, and Single-Agent TGR-1202 to be Featured in Poster Presentations
TG Therapeutics to Host a Reception on Monday December 8th from 7:45 pm – 9:00 pm PT with Presentations by Leading Clinical Investigators
NEW YORK, Nov. 6, 2014 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (Nasdaq:TGTX) today announced that updated data for TG-1101 (ublituximab), the Company's novel, glycoengineered anti-CD20 monoclonal antibody, and TGR-1202, the Company's PI3K delta inhibitor, has been selected for presentation at the upcoming 56th American Society of Hematology Annual Meeting (ASH), to be held December 6 -9, 2014, at the Moscone Center, in San Francisco, CA. Key data from the Company's proprietary combination of TG-1101 and TGR-1202 trial in patients with chronic lymphocytic leukemia (CLL), and non-Hodgkin's lymphoma (NHL) will be presented in an oral presentation. In addition, poster presentations will include updates from the ongoing combination trial of TG-1101 plus ibrutinib, as well as from the ongoing single agent trial of TGR-1202.
Presentations on TG-1101 and TGR-1202 at the ASH meeting include the following:
Oral Presentation:
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Title: Ublituximab, A Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb), In Combination With TGR-1202, A Next Generation Once Daily PI3k delta Inhibitor, Demonstrates Activity In Heavily Pre-Treated And High-Risk CLL And B-Cell Lymphoma
- Oral Session: 801
- Session: 624. Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Indolent B-cell NHL and T-cell NHL
- Date and Time: Tuesday, December 9, 2014 at 8:00AM, during 7:30 – 9:00 AM PT Session
- Location: West Building, 2005-2007-2018-202
- Presenter: Matthew Lunning, DO
Clinical Posters:
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Title: TGR-1202, A Novel Once Daily PI3K delta Inhibitor, Demonstrates Clinical Activity With A Favorable Safety Profile, Lacking Hepatotoxicity, In Patients With CLL And B-Cell Lymphoma
- Abstract Number: 1984
- Session: 642. CLL: Therapy, excluding Transplantation: Poster I
- Date and Time: Saturday, December 6, 2014: 5:30 PM- 7:30 PM PT
- Location: West Building, Level 1
- Presenter: Howard A. Burris III, MD
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Title: Ublituximab (TG-1101), A Novel Glycoengineered Anti-CD20 Monoclonal Antibody, In Combination With Ibrutinib Is Highly Active In Patients With Relapsed and/or Refractory CLL And MCL; Results Of A Phase II Trial
- Abstract Number: 4679
- Session: 642. CLL: Therapy, excluding Transplantation: Poster III
- Date and Time: Monday, December 8, 2014: 6:00 PM- 8:00 PM PT
- Location: West Building, Level 1
- Presenter: Jeff P. Sharman, MD
Pre-Clinical Posters:
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Title: Complementary Targeting of PI3K and the Proteasome Causes Potent Inhibition of mTORC1 and NF-KappaB in Models of B- and T-Cell Lymphoma
- Abstract Number: 1770
- Session: 625. Lymphoma: Pre-Clinical – Chemotherapy and Biologic Agents: Poster I
- Date and Time: Saturday, December 6, 2014: 5:30 PM-7:30 PM PT
- Location: West Building, Level 1
- Presenter: Changchun Deng, MD, PhD
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Title: The PI3K-delta Inhibitor TGR-1202 In Combination with Brentuximab Vedotin (SGN-35) Synergistically Inhibits Tubulin Polymerization and Exerts Potent Antitumor Effects in NOD/SCID Mice with Hodgkin Lymphoma Cell Line Xenografts
- Abstract Number: 4486
- Session: 625. Lymphoma: Pre-Clinical – Chemotherapy and Biologic Agents: Poster III
- Date and Time: Monday, December 8, 2014: 6:00 PM-8:00 PM PT
- Location: West Building, Level 1
- Presenter: Silvia L. Locatelli, PhD
A copy of the above referenced abstracts can be viewed online through the ASH meeting website at www.hematology.org.
TG Therapeutics will also host a reception on Monday, December 8th, 2014 with featured presentations beginning at 8:00pm PT. Presenters will include: Jeff Sharman, MD, with US Oncology Research, Nathan Fowler, MD, with MD Anderson Cancer Center, Matthew Lunning, DO, with University of Nebraska Medical Center and Owen O'Connor, MD, PhD, with Columbia University Medical Center. The event will take place at the San Francisco Marriott Marquis. This event will be webcast and will be available on the Events page, under the Investors & Media tab, of the Company's website at www.tgtherapeutics.com.
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is an innovative, clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for cancer 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 a pre-clinical program to develop IRAK4 inhibitors. 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, the timing of commencing, completing or reporting such trials, the business prospects for TG-1101 and TGR-1202, the potential benefits of combining TG-1101 and TGR-1202may 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 and TGR-1202; the risk that early pre-clinical and clinical results that supported our decision to move forward with TG-1101 and TGR-1202 will not be reproduced in additional patients or in future studies; the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current phase 1 study; 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 hepatotoxicity will be observed in current or future studies; the risk that our ongoing or contemplated drug combinations may not prove tolerable or efficacious; 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.
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