NEW YORK, June 11, 2015 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (Nasdaq: TGTX ), today announced that clinical data for TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody, and TGR-1202, the Company's once-daily PI3K delta inhibitor, will be presented at the 20th Congress of the European Hematology Association (EHA), being held from June 11 - June 14, 2015 in Vienna, Austria as well as at the 13th International Congress on Malignant Lymphoma (ICML), being held from June 17 - June 20, 2015 in Lugano, Switzerland.
The Company and its study investigators will present data from the following clinical studies:
- TGR-1202 as a single agent in relapsed/refractory B-cell malignancies
- TGR-1202 in combination with TG-1101 ("1303 combination") in CLL and NHL
- TGR-1202 + TG-1101 + ibrutinib in B-cell malignancies
- TG-1101 in combination with ibrutinib in patients with relapsed/refractory CLL
Additional information on the presentations can be found below:
20 th Congress of EHA (Vienna):
| Date/Time: | Friday, June 12, 2015, 17:15 - 18:45 CEST |
| Abstract Number: | P327 (Poster) |
| Presentation Title: | UBLITUXIMAB + TGR-1202 DEMONSTRATES ACTIVITY AND FAVORABLE SAFETY PROFILE IN RELAPSED/REFRACTORY B-CELL NHL AND HIGH-RISK CLL |
| Presenter: | Matthew Lunning, DO, University of Nebraska, Omaha, NE |
| Date/Time: | Saturday, June 13, 2015, 11:45 – 12:00 CEST |
| Abstract Number: | S432 (Oral Presentation) |
| Presentation 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 |
| Presenter: | Owen A. O'Connor, MD, PhD, Columbia Presbyterian Lymphoma Center, New York, NY |
ICML Meeting (Lugano):
| Date/Time: | Wednesday, June 17, 2015, 17:45 CEST |
| Abstract Number: | 038 (Oral Presentation) |
| Presentation Title: | TGR-1202, A NOVEL ONCE DAILY PI3K δ INHIBITOR, DEMONSTRATES CLINICAL ACTIVITY WITH A FAVORABLE SAFETY PROFILE, LACKING HEPATOTOXICITY IN PATIENTS WITH CLL AND B-CELL LYMPHOMA |
| Presenter: | Owen A. O'Connor, MD, PhD, Columbia Presbyterian Lymphoma Center, New York, NY |
| Date/Time: | Thursday, June 18, 2015, 17:15 CEST |
| Abstract Number: | 105 (Oral Presentation) |
| Presentation Title: | UBLITUXIMAB (TG-1101), A NOVEL GLYCOENGINEERED ANTI-CD20 MAB, IN COMBINATION WITH IBRUTINIB ACHIEVES 95% ORR IN PATIENTS WITH HIGHRISK RELAPSED/REFRACTORY CLL |
| Presenter: | John Burke, MD, Rocky Mountain Cancer Center/US Oncology, Aurora, CO |
| Date/Time: | Thursday, June 18, 2015, 17:25 CEST |
| Abstract Number: | 106 (Oral Presentation) |
| Presentation Title: | THE CHEMOTHERAPY-FREE TRIPLET OF UBLITUXIMAB, TGR-1202, AND IBRUTINIB IS SAFE AND HIGHLY ACTIVE IN RELAPSED B-CELL MALIGNANCIES |
| Presenter: | Loretta Nastoupil, MD, MD Anderson Cancer Center, Houston, TX |
| Date/Time: | Thursday, June 18, 2015 |
| Abstract Number: | 284 (Poster) |
| Presentation Title: | UBLITUXIMAB + TGR-1202 DEMONSTRATES ACTIVITY AND FAVORABLE SAFETY PROFILE IN RELAPSED/REFRACTORY B-CELL NHL AND HIGH-RISK CLL |
| Presenter: | Matthew Lunning, DO, University of Nebraska, Omaha, NE |
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. 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 pre-clinical programs to develop IRAK4 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, 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 pre-clinical and clinical trials for TG-1101, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies; the risk that early pre-clinical and clinical results that supported our decision to move forward with TG-1101, TGR-1202, the IRAK4 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 data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials, particularly with respect to the incidence of colitis and liver toxicity; 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.
TGTX - G
Jenna Bosco Director - Investor Relations TG Therapeutics, Inc. Telephone: 212.554.4351 Email:
