TG Therapeutics to Present Interim Data from the UNITY-NHL Phase 2b Trial Evaluating Umbralisib Monotherapy in Patients with Marginal Zone Lymphoma at the Upcoming 2019 AACR Annual Meeting
Abstract and full presentation will be publicly available Monday April 1, 2019 at 8:30am ET
Company to host conference call on Monday, April 1, 2019 at 12:00pm (noon) ET, with Dr. Nathan Fowler of MD Anderson Cancer Center and Study Chair of the MZL cohort
NEW YORK, March 29, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases, today announced that interim data from the marginal zone lymphoma (MZL) cohort of the UNITY-NHL Phase 2b pivotal trial to be presented at the upcoming American Association for Cancer Research (AACR) annual meeting has an updated embargo date and time of Monday, April 1, 2019 at 8:30am ET. At that time, the abstract will be available via the AACR meeting website at www.aacr.org, and the data which will be presented during an oral session later that day (details below) will be available on the Company’s website at www.tgtherapeutics.com/publications.cfm.
The Company will also host a conference call with Dr. Nathan Fowler of the MD Anderson Cancer Center and Study Chair of the UNITY-NHL MZL cohort at 12:00pm (noon) ET on Monday April 1, 2019 to review the UNITY-NHL MZL interim data.
Details are provided below outlining the Company’s schedule of events for April 1, 2019. CONFERENCE CALL INFORMATION The Company will host a conference call on Monday April 1, 2019, 12:00pm (noon) ET. Michael S. Weiss, Chief Executive Officer of TG Therapeutics, will host the call, and Dr. Nathan Fowler, Associate Professor of Medicine and Director of Clinical Research in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center in Houston, will review the UNITY-NHL interim MZL data.
In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics AACR Update Call. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.
2019 AACR ORAL PRESENTATION DETAILS
-- Title: Umbralisib monotherapy demonstrates efficacy and safety in patients with relapsed/refractory marginal zone lymphoma: A multicenter, open-label, registration directed Phase II study -Session Date and Time:Monday April 1, 2019 3:00 PM - 5:00 PM ET -Presentation Time: 4:20 PM ET -Session Title:The Next Generation of Clinical Trials in Molecularly-driven Therapy -Session Location:Marcus Auditorium- Bldg A-GWCC -Presenter: Nathan Fowler, MD, Associate Professor, Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX -Abstract Number:7821
ABOUT THE UNITY-NHL PHASE 2b STUDY—Marginal Zone Lymphoma Cohort The multicenter, open-label, UNITY-NHL Phase 2b study - Marginal Zone Lymphoma cohort was designed to evaluate the safety and efficacy of single agent umbralisib, in patients with MZL who have received at least one prior anti-CD20 regimen. The primary endpoint is overall response rate (ORR) as determined by central Independent Review Committee (IRC) assessment.
The MZL cohort completed enrollment in August 2018 with a total of 69 patients enrolled and receiving at least one dose of umbralisib. In February of 2019, the Company announced that the MZL cohort met its primary endpoint of ORR as determined by central IRC for all treated patients (n=69). While the study has already met the Company’s target guidance of 40-50% ORR, the final analysis of ORR will be conducted later this year once all treated patients have had at least 9 cycles (Cycle = 28 days) of follow-up. Secondary endpoints include safety, duration of response, and progression-free survival (PFS).
ABOUT BREAKTHROUGH THERAPY DESIGNATION
The Company announced in January of 2019 that the U. S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for umbralisib for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20 regimen.
The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies.
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 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, 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, TG-1501, its covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as its anti-CD47/CD19 bispecific antibody, TG-1801, into Phase 1 development. TG Therapeutics is headquartered in New York City.
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 interim clinical trial results from the UNITY-NHL MZL cohort that supported Breakthrough Therapy Designation (BTD) or that were accepted for presentation at AACR will not be reproduced in the final data, or if positive, will not be sufficient to support a filing for approval; the risk that the positive data from the UNITY-NHL MZL cohort will not be reproduced in future studies or in other cohorts of the UNITY-NHL study; the risk that the ORR data from the UNITY-NHL MZL cohort will not improve over time; the risk that umbralisib will not receive accelerated approval based on data from the UNITY-NHL MZL cohort; the risk that duration of response or progression free survival data from the UNITY-NHL cohort when available will not be positive or supportive of approval; the risk that safety issues will arise when the safety data is cleaned and analyzed for the UNITY-NHL MZL cohort; the risk that the differentiated tolerability profile for umbralisib previously observed thus far in clinical trials will not be reproduced in the UNITY-NHL study, the UNITY-CLL study or any other on-going studies. 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.
Jenna BoscoSenior Vice President, Corporate CommunicationsTG Therapeutics, Inc.Telephone: 212.554.4351Email: firstname.lastname@example.org