TG Therapeutics Announces Data Presentations at the Upcoming XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL)
August 30 2021 - 7:30AM
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 INFORMATIONOral
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 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 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.
CONTACT:
Investor Relations Email:
ir@tgtxinc.comTelephone: 1.877.575.TGTX (8489), Option 4
Media Relations: Email: media@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 6
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