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TG Therapeutics Initiates Rolling Submission of Biologics License Application to U.S. Food and Drug Administration for Ublituximab in Combination with Umbralisib as a Treatment for Patients with Chronic Lymphocytic Leukemia

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Completion of rolling submission for the BLA expected in 1H21

NDA for umbralisib monotherapy currently under review with the FDA; PDUFA goal date of February 15, 2021 for MZL and June 15, 2021 for FL

NEW YORK, Dec. 01, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that the Company has initiated a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, in combination with umbralisib, the Company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia (CLL). The U.S. FDA previously granted Fast Track Designation to the combination of ublituximab and umbralisib (U2) for the treatment of adult patients with CLL and Orphan Drug Designation (ODD) covering ublituximab in combination with umbralisib for the treatment of CLL. The Company expects to complete the BLA rolling submission in the first half of 2021.

Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, “The initiation of a BLA submission for ublituximab in combination with umbralisib is an important milestone for us, and one that brings us one step closer to our goal of developing combination therapies for patients in need. This application, as well as the recently granted Fast Track Designation, is supported by the UNITY-CLL Phase 3 trial which met its primary endpoint of improvement in progression-free survival compared to obinutuzumab plus chlorambucil and will be presented in an oral presentation at the 2020 American Society of Hematology (ASH) annual meeting beginning this weekend.” Mr. Weiss continued, “I want to thank the patients, caregivers and research teams who participated in our clinical trials and helped to advance the U2 combination to this stage. We believe, if approved, U2 has the potential to become an important treatment option to both front line and relapsed/refractory patients with CLL.”

The Company has previously submitted a New Drug Application (NDA) to the FDA for umbralisib to treat relapsed/refractory marginal zone lymphoma (MZL) and follicular lymphoma (FL) and the FDA has granted Prescription Drug User Fee Act (PDUFA) goal dates of February 15, 2021 for MZL and June 15, 2021 for FL.

ABOUT UNITY-CLL PHASE 3 TRIAL
UNITY-CLL is a global Phase 3 randomized controlled clinical trial comparing the combination of ublituximab plus umbralisib, or U2, to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory chronic lymphocytic leukemia (CLL). The trial randomized patients into four treatment arms: ublituximab single agent, umbralisib single agent, ublituximab plus umbralisib, and an active control arm of obinutuzumab plus chlorambucil. A prespecified analysis was conducted to assess the contribution of ublituximab and umbralisib in the U2 combination arm and allowed for the termination of the single agent arms. Accordingly, the UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil. Approximately 420 subjects enrolled to the two combination arms and approximately 60% of patients were treatment-naïve and 40% were relapsed or refractory. The primary endpoint for this study was superior progression-free survival (PFS) for the U2 combination compared to the control arm to support the submission for full approval of the U2 combination in CLL. Positive topline results from this trial were announced in May 2020. The UNITY-CLL Phase 3 trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

ABOUT CHRONIC LYMPHOCYTIC LEUKEMIA
Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia, and in 2020 it is estimated there will be more than 20,000 new cases of CLL diagnosed in the United States1. Although signs of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of malignant cells.

ABOUT FAST TRACK
Fast Track is a program designed to expedite the development and review of drugs that treat serious conditions and that demonstrate the potential to address an unmet medical need. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy that may be potentially better than available therapy.

A drug that receives Fast Track designation is eligible for more frequent interactions with the FDA, priority review if relevant criteria are met, and rolling submission of the Biologics License Application or New Drug Application.

ABOUT ORPHAN DRUG DESIGNATION
Orphan drug designation is granted by the FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain incentives which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity.

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 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 naïve 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 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.

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1 Cancer Stat Facts: Leukemia – Chronic Lymphocytic Leukemia
https://seer.cancer.gov/statfacts/html/clyl.html

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 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 Company will not complete its planned U.S. regulatory submissions for ublituximab in combination with umbralisib in patients with CLL in the projected timeframe or at all; the risk that the FDA will not accept the BLA submission of ublituximab in combination with umbralisib in patients with CLL; the risk that the FDA will not approve the pending NDA for umbralisib or the BLA for ublituximab in combination with umbralisib; the risk that safety issues or trends will be observed in the UNITY-CLL study when the full safety dataset is available or in any other on-going studies that prevent approval of either ublituximab and/or umbralisib; the risk that our product candidates, including ublituximab and umbralisib, will not be commercially successful if approved; the risk that the differentiated tolerability profile for umbralisib previously observed in clinical trials will not be reproduced in the UNITY-CLL trial or any other on-going studies; and the risk that we are not able to achieve the clinical trial and regulatory 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.


CONTACT:

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