NEW YORK, Nov. 03, 2016 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX ), today announced that updated data for TGR-1202, the Company’s once-daily PI3K delta inhibitor, and TG-1101 (ublituximab), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, have been selected for presentation at the upcoming 58 th American Society of Hematology (ASH) annual meeting, to be held December 3-6, 2016, at the San Diego Convention Center in San Diego, California.
“We are looking forward to an exciting ASH conference as we continue to present data on the differentiation between TGR-1202 and the first generation PI3K delta inhibitors. With three oral presentations and three poster presentations it is clear the strength of TGR-1202, and our overall UNITY program, is starting to be noticed by leaders in the treatment of B-cell malignancies. We have seen scientific and clinical interest in our programs continue to grow, and notably all three of the oral presentations at this coming ASH meeting resulted from independent investigator driven interest in working with TGR-1202. We look forward to sharing this data at the upcoming meeting and expanding on our investigator initiated collaborations while we continue to drive our registration-directed trials toward pivotal data in 2017, potentially leading to our first approval in 2018,” stated Michael S. Weiss, the Company's Executive Chairman and Interim CEO. Presentations at the ASH 2016 meeting include the following:
Oral Presentations:
- Title: Silencing c-Myc Translation as a Therapeutic Strategy through Targeting PI3K Delta and CK1 Epsilon in Hematological Malignancies
- Abstract Number: 291
- Oral Session: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Cell Signaling
- Date and Time: Sunday, December 4, 2016; 7:30 AM - 9:00 AM PT
- Presentation Time: 8:00 AM PT
- Location: San Diego Convention Center, Room 5AB
- Presenter: Changchun (George) Deng, MD, PhD, Columbia University, New York, NY
- Title: TGR-1202 in Combination with Ibrutinib in Patients with Relapsed or Refractory CLL or MCL: Preliminary Results of a Multicenter Phase I/Ib Study
- Abstract Number: 641
- Oral Session: 642. CLL: Therapy, excluding Transplantation: Targeted Therapy: Novel Agents and Combinations
- Date and Time: Monday, December 5, 2016; 7:00 AM - 8:30 AM PT
- Presentation Time: 8:00 AM PT
- Location: San Diego Convention Center, Room 5AB
- Presenter: Matthew S. Davids, MD, Dana Farber Cancer Institute, Boston, MA
- Title: Preliminary Results from a Phase I Dose Escalation Trial of Ruxolitinib and the PI3Kδ Inhibitor TGR-1202 in Myelofibrosis
- Abstract Number: 1125
- Oral Session: 634. Myeloproliferative Syndromes: Clinical: Clinical Trials with JAK Inhibitors
- Date and Time: Monday, December 5, 2016; 4:30 PM - 6:00 PM PT
- Presentation Time: 5:00 PM PT
- Location: Marriott Marquis San Diego Marina, Pacific Ballroom Salons 15-17
- Presenter: Tamara Kay Moyo, MD, PhD, Vanderbilt-Ingram Cancer Center, Nashville, TN
Posters Presentations:
- Title: Modulation of T Cell Compartment in a Preclinical CLL Murine Model By a Selective PI3K Delta Inhibitor, TGR-1202
- Abstract Number: 3236
- Session: 642. CLL: Therapy, excluding Transplantation: Poster II
- Date and Time: Sunday, December 4, 2016 6:00 PM - 8:00 PM PT
- Location: San Diego Convention Center, Hall GH
- Presenter: Kamira K. Maharaj, BS, Moffit Cancer Center, Tampa, FL
- Title: Combination of Ublituximab, TGR-1202, and Bendamustine Demonstrates Significant Activity in Patients with Advanced DLBCL 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 5, 2016; 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
- Title: A Phase I Trial of TGR-1202, a Next Generation Once-Daily PI3Kδ Inhibitor, in Combination with Brentuximab Vedotin, in Patients with Relapsed/Refractory Hodgkins Lymphoma
- Abstract Number: 4146
- Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster III
- Date and Time: Monday, December 5, 2016; 6:00 PM-8:00 PM PT
- Location: San Diego Convention Center, Hall GH
- Presenter: Rod Ramchandren, MD, Karmanos Cancer Center, Detroit, MI
A copy of the above referenced abstracts can be viewed online through the ASH meeting website at www.hematology.org . Following each presentation, the data presented will be available on the Publications page of the Company’s website at www.tgtherapeutics.com .
TG Therapeutics will also host an investor and analyst reception on Monday, December 5 th , 2016 beginning at 8:00pm PT. The event will take place at the Marriott Gaslamp, in San Diego, California.
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 recently entering 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 with respect to anticipating future clinical trials, the timing of commencing or completing such trials and business prospects for TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR 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 successfully and cost-effectively complete preclinical and clinical trials for TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies; the risk that early preclinical and clinical results that supported our decision to move forward with TG-1101, TGR-1202, the IRAK4 inhibitor program, the BET inhibitor program, and the anti-PD-L1 and anti-GITR antibodies will not be reproduced in additional patients or in future studies; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 will not continue, 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 combination of TG-1101 and TGR-1202, referred to as TG-1303, will not prove to be a safe and efficacious backbone for triple and quad combination therapies; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior preclinical and clinical trials; 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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CONTACT: Jenna Bosco Vice President, Investor Relations TG Therapeutics, Inc. Telephone: 212.554.4351 Email: ir@tgtxinc.com
