TG Therapeutics Announces FDA Acceptance of New Drug Application for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone…

August 13, 2020 07:00 ET | Source: TG Therapeutics, Inc.

NEW YORK, Aug. 13, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc.(NASDAQ: TGTX), today announced that theU.S. Food and Drug Administration(FDA) has accepted the Companys New Drug Application (NDA) for umbralisib, the Companys investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and follicular lymphoma (FL) who have received at least two prior systemic therapies. The MZL indication, under Breakthrough Therapy Designation (BTD), has been accepted for Priority Review and has a Prescription Drug User Fee Act (PDUFA) goal date of February 15, 2021. The FL indication has been accepted for standard review with a PDUFA goal date of June 15, 2021.The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss this application.

Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "We are extremely pleased with the FDAs acceptance of our first NDA submission and look forward to working with the FDA during the review process. This is a significant achievement in our path towards accomplishing our goal of developing novel treatments for patients with B-cell diseases. Mr. Weiss continued, If approved, we believe umbralisib could become an important treatment option for patients with previously treated MZL and FL. We look forward to presenting the data from the UNITY-NHL trial that supported this NDA submission by year end.

The NDA for umbralisib was based primarily on data from the umbralisib monotherapy MZL and FL cohorts of the UNITY-NHL Phase 2b trial evaluating patients with relapsed/refractory MZL or FL. The Company has previously announced that each cohort met its primary endpoint of overall response rate (ORR), meeting the Companys target guidance of 40-50% ORR, as confirmed by an Independent Review Committee (IRC). The FDA has also previously granted umbralisib Breakthrough Therapy Designation (BTD) for MZL and orphan drug designation (ODD) for MZL and FL.

ABOUT THE UNITY-NHL PHASE 2b STUDYMZL & FL COHORTS The UNITY- NHL trial is a global multicenter, open-label Phase 2b trial.

The MZL cohort was designed to evaluate the safety and efficacy ofsingle agent umbralisib in patients with MZL who have received at least one prior anti-CD20 regimen. In February of 2019, the Company announced that the primary endpoint of overall response rate (ORR) as determined by Independent Review Committee (IRC) was met for all treated MZL patients. The results met the Companys target guidance of 40-50% ORR. Interim safety and efficacy data from the MZL cohort were presented in oral presentations in 2019 at the American Association for Cancer Research (AACR) annual meeting, the American Society of Clinical Oncology (ASCO) annual meeting and the International Conference on Malignant Lymphoma (ICML).

The FL cohort was designed to evaluate the safety and efficacy ofsingle agent umbralisib in patients with FL who were relapsed or refractory following at least two prior lines of therapy, including an anti-CD20 regimen and an alkylating agent. In October of 2019, the Company announced that the primary endpoint of ORR as determined by IRC was met for all treated FL patients. The results met the Companys prespecified response target of 40-50% ORR.

On June 15, 2020, the Company announced the completion of the rolling submission of a NDA to theFDA requesting accelerated approval of umbralisib as a treatment for patients with previously treated MZL and FL.

On August 12, 2020, the Company received notification from the FDA of its acceptance of the Companys NDA for umbralisib as a treatment for patients with previously treated MZL and FL.

ABOUT MARGINAL ZONE LYMPHOMA Marginal zone lymphoma (MZL) comprises a group of indolent (slow growing) mature B-cell non-Hodgkin lymphomas (NHLs). MZL is generally considered a chronic and incurable disease. With an annual incidence of approximately 7,500 newly diagnosed patients in the United States1, MZL is the third most common B-cell NHL, accounting for approximately eight percent of all NHL cases. MZL consists of three different subtypes: extranodal MZL of the mucosal-associated lymphoid tissue (MALT), nodal marginal zone lymphoma (NMZL), and splenic marginal zone lymphoma (SMZL)2.

ABOUT FOLLICULAR LYMPHOMA Follicular lymphoma (FL) is typically an indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes.It is the second most common form of NHL. FL is generally not curable and is considered a chronic disease, as patients can live for many years with this form of lymphoma. With an annual incidence inthe United Statesof approximately 15,000 newly diagnosed patients3, FL is the most common indolent lymphoma accounting for approximately 20 percent of all NHL cases4.

ABOUT TG THERAPEUTICS, INC.TG Therapeuticsis a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is in late stage clinical development with two investigational compounds, ublituximab and umbralisib, the combination of which is referred to as U2, targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes.Umbralisib (TGR-1202) is an oral, once-daily dual inhibitor of PI3K-delta and CK1-epsilon.Umbralisib is currently under review by the U.S. Food and Drug Administration (FDA) for accelerated approval as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen or follicular lymphoma (FL) who have received at least two prior systemic therapies. The Company also has a fully enrolled Phase 3 clinical trial evaluating U2 in patients with treatment nave and relapsed/refractory chronic lymphocytic leukemia (CLL), and two fully enrolled identical Phase 3 trials evaluating ublituximab monotherapy in patients with relapsing forms of multiple sclerosis (RMS). Additionally, the Company has recently brought into Phase 1 clinical development its anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), its covalently-bound Brutons Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as its anti-CD47/CD19 bispecific antibody, TG-1801. TG Therapeuticsis headquartered inNew York City.

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12016 Lymphoid Malignancy Statistics by World Health Organization Subtypes VOLUME 66 _ NUMBER 6 _ NOVEMBER/DECEMBER 2016https://onlinelibrary.wiley.com/doi/pdf/10.3322/caac.213572Lymphoma Research Foundation: Marginal Zone Lymphomahttps://lymphoma.org/aboutlymphoma/nhl/mzl/3American Cancer SocietyKey Statistics for Non-Hodgkin Lymphoma 4Lymphoma Research FoundationFollicular Lymphoma

Cautionary Statement This press release contains 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 theSecurities and Exchange Commission, factors that could cause our actual results to differ materially include the following: the risk that umbralisib may not receive regulatory approval for previously treated MZL or FL in the currently anticipated timeline or at all; the risk that the FDA may grant approval that is more restrictive than anticipated; our ability to successfully 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; and the risk that the COVID-19 pandemic causes unforeseen delays in the FDA timelines we have outlined or in our ability to achieve other milestones we project. 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 atwww.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

CONTACT:

Jenna Bosco Senior Vice President, Corporate Communications TG Therapeutics, Inc. Telephone: 212.554.4351 Email: ir@tgtxinc.com

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TG Therapeutics Announces FDA Acceptance of New Drug Application for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone...