TG Therapeutics Highlights Data Selected for Presentation at the 63rd American Society of Hematology (ASH) Annual Meeting

Rhea-AI Summary

TG Therapeutics announced six abstracts for the 63rd ASH annual meeting, scheduled for December 11-14, 2021, in Atlanta, Georgia. Key presentations will include new data from the UNITY-NHL Phase 2b trial and two analyses from the UNITY-CLL Phase 3 trial, focusing on patients with comorbidities. The company emphasizes the potential of its U2 combination therapy for B-cell malignancies. Oral and poster presentations are detailed, showcasing the innovations in treating chronic lymphocytic leukemia and B-cell malignancies. More information is available on ASH's website.

Positive

• Presentation of six abstracts at the ASH annual meeting highlights TG Therapeutics' ongoing research and innovation.
• New data from UNITY-NHL Phase 2b trial suggest effective treatment approaches in relapsed or refractory lymphoma.
• Emphasis on U2 combination therapy indicates a strong B-cell platform with multiple product opportunities.

Negative

• No specific financial metrics or timelines for future product approvals were disclosed, which may raise investor concerns.
• Risks associated with clinical trial results and regulatory approvals remain, as per cautionary statements.

NEW YORK, Nov. 04, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the release of six abstracts that will be presented at the upcoming 63^rd American Society of Hematology (ASH) annual meeting and exposition, to be held December 11 – 14, 2021, virtually and also live at the Georgia World Congress Center in Atlanta, Georgia. Abstracts are now publicly available online via the ASH meeting website at www.hematology.org.

Michael S. Weiss, Chairman and Chief Executive Officer, stated, “We are looking forward to a live ASH annual meeting this year where we will be sharing six presentations, including three oral presentations. Specifically, we are pleased to share new data from the UNITY-NHL Phase 2b trial showing the U2 combination in patients with relapsed or refractory marginal zone lymphoma and diffuse large b-cell lymphoma. We are also excited to share two novel analyses from the UNITY-CLL Phase 3 trial. One highlighting the outcomes of U2 treated patients who had comorbidities or required certain concomitant medications, both of which represent areas of high unmet need as these patients may be poor candidates for BTK therapy. The other presentation sharing the efficacy and safety of U2 by CLL pre-treatment status, that is, comparing the treatment naïve cohort with the previously treated cohort. Finally, we will also share two presentations from studies evaluating U2 triplet regimens with a BTK, namely TG-1701 and ibrutinib. We believe these presentations showcase the strength of our combination B-cell platform, which has the potential to produce multiple product opportunities in the future.”

ASH Presentation Details:

Oral Presentations:
Oral Presentation Title: The Combination of Umbralisib Plus Ublituximab Is Active in Patients with Relapsed or Refractory Marginal Zone Lymphoma (MZL): Results from the Phase 2 Global Unity-NHL Trial

• Session Date/Time: Saturday, December 11, 2021 / 10:00 AM ET
• Session Name: 623. Mantle Cell, Follicular, and Other B-Cell Lymphomas: Clinical and Epidemiological: Targeted Therapy in Low Grade Lymphoma
• Room: Georgia World Congress Center, A411-A412
• Lead Author: Julio Chavez, MD, MS, Moffitt Cancer Center, Tampa, FL
  

Oral Presentation Title: Efficacy and Safety of Umbralisib, Ublituximab (U2), and U2 Plus Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

• Session Date/Time: Sunday, December 12, 2021 / 5:30 PM ET       
• Session Name: 626. Aggressive Lymphomas Prospective Therapeutic Trials: Novel Agents and Combinations
• Room: Georgia World Congress Center, Thomas Murphy Ballroom 1-2
• Lead Author: John Burke, MD, Rocky Mountain Cancer Centers / US Oncology Research, Aurora, CO

Oral Presentation Title: A Phase 2 Study Evaluating the Addition of Ublituximab and Umbralisib (U2) to Ibrutinib in Patients with Chronic Lymphocytic Leukemia (CLL): A Minimal Residual Disease (MRD)-Driven, Time-Limited Approach

• Session Date/Time: Sunday, December 12, 2021 / 10:30 AM ET
• Session Name: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological I
• Room: Georgia World Congress Center, B401-B402
• Lead Author: Lindsey E. Roeker, MD, CLL Program, Leukemia Service, Division of Hematologic Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY

Poster Presentations:
Poster Presentation Title: The Selective Bruton Tyrosine Kinase (BTK) Inhibitor TG-1701 As Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Patients with B-Cell Malignancies

• Date/Time: Saturday, December 11, 2021 / 5:30 PM - 7:30 PM ET
• Session Name: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster I
• Location: Georgia World Congress Center, Hall B5
• Lead Author: Chan Y. Cheah, MBBS, DMSc, Linear Clinical Research, Nedlands, Australia; Medical School, University of Western Australia, Perth, Australia; and Department of Haematology, Sir Charles Gairdner Hospital, Perth, Australia

Poster Presentation Title: Favorable Outcomes for Patients Treated with U2 with Co-Morbidities or Concomitant Medications: A Retrospective Analysis of Unity-CLL Phase 3 Trial

• Date: Monday, December 13, 2021 / 6:00 PM - 8:00 PM
• Session Name: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III
  Location: Georgia World Congress Center, Hall B5
• Lead Author: Javier Pinilla-Ibarz, MD, Lymphoma Section Head, Director of Immunotherapy, Malignant Hematology Division at the H. Lee Moffitt Cancer Center in Tampa, Florida
  

Poster Presentation Title: Efficacy and Safety of Ublituximab in Combination with Umbralisib (U2) in Patients with Chronic Lymphocytic Leukemia (CLL) By Treatment Status: A Sub-Analysis of the Phase 3 Unity-CLL Study

• Date/Time: Monday, December 13, 2021 / 6:00 PM - 8:00 PM
• Session Name: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Poster III
• Location: Georgia World Congress Center, Hall B5
• Lead Author: Ryan Jacobs, MD, Department of Hematology, Lymphoma Division, Assistant Professor of Medicine, Levine Cancer Institute/Atrium Health, Charlotte, NC

Abstracts are now publicly available via the ASH meeting website at www.hematology.org. Final presentations will be accessible at the above dates/times via the publications page of TG corporate website at http://tgtxinc.com/publications.cfm.

ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a fully-integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. In addition to an active research pipeline including five investigational medicines across these therapeutic areas, TG has received accelerated approval from the U.S. FDA for UKONIQ^® (umbralisib), for the treatment of adult patients with relapsed/refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and relapsed/refractory follicular lymphoma who have received at least three prior lines of systemic therapies. Currently, the Company has three programs in Phase 3 development for the treatment of patients with relapsing forms of multiple sclerosis (RMS) and patients with chronic lymphocytic leukemia (CLL) and several investigational medicines in Phase 1 clinical development. For more information, visit www.tgtherapeutics.com, and follow us on Twitter @TGTherapeutics and Linkedin.

UKONIQ^® is a registered trademark of TG Therapeutics, Inc.

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 include the following: 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; the risk that we will not be able to meet the regulatory submission or clinical trial 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; and the risk that our compounds will not receive regulatory approval or become commercially successful products. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, our most recent Quarterly Report filed on Form 10-Q, and our other filings with the U.S. Securities and Exchange Commission.

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:

Investor Relations
Email: ir@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 4

Media Relations:
Email: media@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 6

FAQ

What abstracts will TGTX present at the ASH annual meeting 2021?

TG Therapeutics will present six abstracts, including key findings from the UNITY-NHL Phase 2b trial and the UNITY-CLL Phase 3 trial.

When is the ASH annual meeting where TGTX will present?

The ASH annual meeting will take place from December 11 to 14, 2021.

What is the focus of TGTX's presentations at ASH 2021?

The presentations will focus on novel treatments for relapsed or refractory B-cell malignancies and data on U2 therapies.

What is the significance of the UNITY-NHL and UNITY-CLL trials for TGTX shareholders?

These trials may reinforce TGTX's position in the market and showcase potential new therapies, impacting future revenues.

What are the risks mentioned in TGTX's recent press release?

The risks include uncertainty in clinical trial outcomes and potential delays in regulatory approvals.