TG Therapeutics Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma or Follicular Lymphoma
Jun 17, 2020
ABOUT THE UNITY-NHL PHASE 2b STUDY—MZL & FL COHORTS
The UNITY- NHL trial is a multicenter, open-label Phase 2b trial.
The MZL cohort was designed to evaluate the safety and efficacy of single agent umbralisib, in patients with MZL
The FL cohort was designed to evaluate the safety and efficacy of single agent umbralisib in patients with FL
ABOUT MARGINAL ZONE LYMPHOMA
Marginal zone lymphoma (MZL) comprises a group of indolent (slow growing) B-cell non-Hodgkin lymphomas (NHLs) that begin forming in the marginal zone of lymphoid tissue. With an annual incidence of approximately 7,500 newly diagnosed patients in
ABOUT FOLLICULAR LYMPHOMA
Follicular lymphoma (FL) is typically a slow-growing or indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes, making it a B-cell lymphoma. Follicular lymphoma is generally not curable and is a chronic disease. Patients can live for many years with this form of lymphoma. With an annual incidence in the United States of approximately 15,000 newly diagnosed patients3, FL is the most common indolent lymphoma accounting for approximately 20 percent of all NHL cases4.
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 dual inhibitor of PI3K-delta and CK1-epsilon, which may overcome certain tolerability issues associated with first generation PI3K-delta inhibitors. 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 into Phase 1 clinical development its anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), its covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as its anti-CD47/CD19 bispecific antibody, TG-1801. TG Therapeutics is headquartered in New York City.
1 2016 Lymphoid Malignancy Statistics by World Health Organization Subtypes VOLUME 66 _ NUMBER 6 _ NOVEMBER/DECEMBER 2016 https://onlinelibrary.wiley.com/doi/pdf/10.3322/caac.21357
3 American Cancer Society “Key Statistics for Non-Hodgkin Lymphoma”
4 Lymphoma Research Foundation “Follicular Lymphoma”
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, including statements relating to the NDA submission of umbralisib, the clinical development of our product candidates, and anticipated milestones. For these statements, which are subject to a number of risks and uncertainties, 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 include the following: the risk that the FDA will not accept the NDA submission of umbralisib in patients with previously treated MZL or FL; the risk that the clinical trial results from the UNITY-NHL MZL or FL cohorts will not be sufficient to support accelerated approval or any regulatory approval of umbralisib for previously treated MZL or FL; the risk that the FDA may delay approval of the umbralisib NDA or grant approval that is more restrictive than anticipated; our ability to commercially launch umbralisib for previously treated MZL or FL, if those indications are approved by the FDA; our ability to successfully and cost-effectively complete our ongoing and planned clinical trials; the risk that early clinical trial results (both safety and efficacy), which may have influenced our decision to proceed with additional clinical trials, will not be reproduced in future studies; the risk that data from the UNITY-CLL Phase 3 trial or the Ultimate I&II trials will not be available in the planned timeframe or not be sufficient to support a regulatory submission; the risk that regulatory submissions will not be completed in the planned timeframe; and our ability to achieve the milestones we project, including the risk that the evolving and unpredictable COVID-19 pandemic delays achievement of those milestones. 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.
Senior Vice President,
Source: TG Therapeutics, Inc.