TG Therapeutics Announces Data Presentations at the Upcoming XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL)
TG Therapeutics, Inc. (NASDAQ: TGTX) announced four data presentations at the virtual XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL) from September 17 to 20, 2021. Key highlights include the Phase 3 UNITY-CLL study showing the superiority of its U2 therapy over competitors in treatment-naïve and relapsed forms of Chronic Lymphocytic Leukemia (CLL). Additionally, updated Phase 1 results of a triple combination therapy will be shared, which has led to the initiation of the ULTRA-V Phase 2/3 trial. The PDUFA date for U2 is March 25, 2022.
- Presentation of encouraging Phase 1 results for U2 and venetoclax, leading to the ULTRA-V trial initiation.
- U2 therapy deemed superior to current treatments for chronic lymphocytic leukemia, increasing its market potential.
- PDUFA date for U2 set for March 25, 2022, indicating potential regulatory approval.
- None.
NEW YORK, Aug. 30, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of four data presentations at the upcoming XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL), being held virtually September 17 – 20, 2021. Details of the data presentations are included below.
“We are excited to share data from four combination clinical trials at the upcoming iwCLL conference, all of which evaluated either U2, the combination of UKONIQ plus ublituximab, alone or as a backbone in a triple combination regimen. We believe these data further highlight the potential of the U2 combination, which currently has a PDUFA date of March 25, 2022, to treat patients with CLL.” Mr Weiss continued, “We are particularly excited to be able to share, earlier than expected, the updated Phase 1 results from the triple combination of U2 plus venetoclax in patients with relapsed/refractory CLL. The data shown thus far from this phase 1/2 study has been highly encouraging and led to the commencement of our ULTRA-V Phase 2/3 trial, which is also evaluating the U2 plus venetoclax triple combination.”
IwCLL 2021 PRESENTATION INFORMATION
Oral Presentation Title: Umbralisib Plus Ublituximab (U2) Is Superior to Obinutuzumab Plus Chlorambucil (O+Chl) in Patients with Treatment-Naïve (TN) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 UNITY-CLL Study
- Abstract Number: 1083667
- Presentation Date/Time: Saturday September 18, 2021 at 1:30 PM EDT/ 19:30 CEST
- Session: Session 6: Front-Line Therapy of CLL
- Lead Author: Wojciech Jurczak, MD, PhD, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland
Oral Presentation Title: A Phase 1/2 Study of Umbralisib, Ublituximab, and Venetoclax in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
- Abstract Number: 1083987
- Presentation Date/Time: Sunday September 19, 2021 at 10:50 AM EDT/ 16:50 CEST
- Session: Session 8: New Agents in CLL Clinical Trials
- Lead Author: Paul M. Barr, MD, Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY
Oral Poster Presentation Title: TG-1701, a Selective Bruton Tyrosine Kinase (BTK) Inhibitor, as Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Patients with Chronic Lymphocytic Leukemia
- Abstract Number: 1083634
- Presentation Date/Time: Sunday September 19, 2021 at 2:00 PM EDT/ 20:00 CEST
- Session: Poster Session
- Lead Author: Chan Y. Cheah MBBS, DMSc, Linear Clinical Research, and Department of Haematology, Sir Charles Gairdner Hospital, Nedlands Western Australia, and Medical School, University of Western Australia, Crawley, Western Australia
Poster Presentation Title: Phase I/II Study of Umbralisib (TGR-1202), Ublituximab (TG-1101), and Pembrolizumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia and Richter’s Transformation: 5-Year Follow-up
- Abstract Number: 1083523
- Presentation Date/Time: Available on demand
- Session: Virtual Poster Gallery
- Lead Author: Lindsey E. Roeker, MD, CLL Program, Leukemia Service, Division of Hematologic Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY
Currently, the conference agenda, including abstract titles, is available via the iwCLL website at https://iwcll2021.org/. Full text abstracts will be publicly available on September 13, 2021.
At the time of each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.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 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.
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FAQ
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