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TG Therapeutics Highlights Data Selected for Presentation at the 62nd American Society of Hematology (ASH) Annual Meeting

Published: 2020-11-04 16:45:00 ET
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UNITY-CLL: U2 significantly improved progression-free survival over obinutuzimabplus chlorambucil (HR=0.54, p 5% of patients were neutropenia (23%), leukopenia (13%), and infusion related reactions (8%). No TLS events were observed during venetoclax administration. •Conclusion: Results suggest that this chemotherapy-free regimen can provide undetectable MRD after only 12 cycles of treatment, representing an effective 12-month treatment option for this population

Poster Presentation Title: Clinical Activity of TG-1701, As Monotherapy and in Combination with Ublituximaband Umbralisib(U2), in Patients with B-Cell Malignancies

 A total of 102 patients have been treated with TG-1701, with patients receiving monotherapy in the dose-escalation cohort (n=25) or in the dose-expansion cohort (n=63), or TG-1701 in combination with U2 in the dose escalation cohort (n=14)
 TG-1701 monotherapy was well tolerated and the maximum tolerated dose was not reached up through 400 mg QD
 The most common Grade ≥3 treatment-related adverse events (TRAE) were neutropenia (5%) on monotherapy, and neutropenia and ALT/AST increases for 1701+U2 (both 21%). There were no G4 TRAE with TG-1701 monotherapy
 With a median follow up of 4.6 months in the 200 mg QD monotherapy expansion cohorts, preliminary overall response rates (ORR) were: 85% (17/20) in CLL, 42% (5/12) in MCL, and 86% (12/14) in WM
 The ORR for 1701+U2 was 100% in patients with WM, CLL, MZL and DLBCL (n=7) and 67% (4/6) in FL

Abstracts are now publicly available via the ASH meeting website at www.hematology.org and also accessible via the publications page of TG corporate website at http://tgtxinc.com/publications.cfm

CONFERENCECALL INFORMATIONThe Company is hosting a zoom conference call tomorrow, November 5, 2020, which will begin at 8:45 AM ET.

In order to participate in the call, please join via the zoom webinar link: https://bit.ly/37XZai1, which will also be available on the Events page, located within the Investors & Media section, of the Company's website at https://ir.tgtherapeutics.com/events. Attendees may also join via phone by dialing 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics ASH Abstract Review Call. A recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

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 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.

Cautionary StatementThis 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 include the following: the risk that the results of the UNITY-CLL trial will not be sufficient or acceptable to support regulatory submission of the combination of ublituximab (TG-1101) and umbralisib (TGR-1202) (U2) for the treatment of CLL; the risk that the results of the UNITY-NHL trial in previously treated FL and MZL will not be sufficient to support accelerated approval of our pending NDA for umbralisib; the risk that we will not be able to meet the regulatory submission timelines that we project or achieve other anticipated milestones, including the risk that the evolving and unpredictable COVID-19 pandemic delays achievement of those milestones; the risk that interim, top-line, or other early clinical trial results, that may have supported the acceptance of our data for presentation or influenced our decision to proceed with additional clinical trials, will not be reproduced in final data sets or in future studies; the risk that the safety profile observed with umbralisib, ublituximab or TG-1701, or combinations thereof, may change as additional patients are exposed for longer durations; the risk that the U2 combination will not prove to be a safe and efficacious combination, or backbone for triple therapy combinations, including with venetoclax and TG-1701. 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 

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Source: TG Therapeutics, Inc.