TG Therapeutics Announces Preclinical and Clinical Data Evaluating TG-1701 at the 16th International Congress on Malignant Ly...
June 18 2021 - 7:35AM
TG Therapeutics, Inc. (NASDAQ: TGTX), today announced data from two
presentations evaluating TG-1701, the Company’s investigational
once-daily, oral BTK inhibitor, presented today during the 16th
International Congress on Malignant Lymphoma (ICML). One
presentation evaluated TG-1701 preclinically and the other included
Phase 1 data evaluating TG-1701 as a monotherapy and as a triple
therapy in combination with ublituximab, the Company’s novel
glycoengineered anti-CD20 monoclonal antibody, and UKONIQ®
(umbralisib), the Company’s once-daily, inhibitor of PI3K-delta and
CK1-epsilon in patients with front line or relapsed/refractory
non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia
(CLL). The Phase 1 data presented today were previously presented
at the 2021 American Society of Clinical Oncology (ASCO) annual
meeting and the 2021 European Hematology Association annual
meeting.
PRESENTATION HIGHLIGHTS:
Poster Presentation
Title: Antitumoral activity of the
novel BTK inhibitor TG-1701 is associated with disruption of Ikaros
signaling and improvement of anti-CD20 therapy in B-cell
non-Hodgkin lymphoma
- TG-1701 is a novel irreversible BTK inhibitor currently in
Phase 1 clinical development, as monotherapy or in combination with
ublituximab and UKONIQ (umbralisib).
- In patient samples from a Phase 1 clinical trial of TG-1701,
phosphoproteomic analysis differentiated early and late CLL
responders to TG-1701 therapy.
- Disruption of an active Ikaros pathway is a signature of early
responders, while absence of Ikaros modulation upon TG-1701 therapy
is a signature of non-/late responders.
- TG-1701 did not impair FcγR-driven ADCC and ADCP and cooperated
with U2 in in vitro and in vivo models of BTKi-sensitive and
BTKi-resistant B-NHL.
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 B-cell
Malignancies
- A total of 125 patients with R/R CLL or B-cell lymphoma have
been treated with TG-1701, with patients receiving monotherapy in
the dose-escalation cohort (n=25), 200 mg in a dose-expansion
cohort (n=61), 300 mg in a CLL dose-expansion cohort (n=20), or
TG-1701 in combination with U2 in the dose escalation cohort
(n=19).
- TG-1701 monotherapy was well tolerated and the maximum
tolerated dose was not reached up to 400 mg QD.
- Adverse Events (AEs) of special interest in patients treated
with 200 mg and 300 mg QD of TG-1701 (n=81), included Grade 3
hypertension (4.9%), atrial fibrillation (1.2%), and no instances
of major bleeding observed. Grade 3 AEs occurring in ≥10% of
patients treated with U2+1701 included diarrhea (11%), neutropenia
(11%), ALT increase (16%), and AST increase (16%), and Grade 4 AEs
occurring in ≥10% of patients treated with U2+1701 included
neutropenia (11%).
- At a median follow up of 12.2 months in the 200 mg QD
monotherapy expansion cohorts, overall response rates (ORR) were:
95% (19/20) in CLL, 65% (13/20) in mantle cell lymphoma (MCL), and
95% (19/20) in Waldenstrom macroglobulinemia (WM).
- 100% ORR observed at a median follow up of 8.6 months in the
300 mg CLL monotherapy cohort (n=19).
- At a median follow up of 15.6 months, the 1701+U2 dose
escalation (using doses of 100mg to 300 mg QD of TG-1701) resulted
in 79% ORR, with 21% CR rate across patients with WM, CLL, marginal
zone lymphoma (MZL), diffuse large B-cell lymphoma (DLBCL) and
follicular lymphoma (FL) (n=19).
Data presented at ICML 2021 is available on the Publications
page of the Company’s website at
https://www.tgtherapeutics.com/publications/. 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 two 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
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 U.S. Private Securities
Litigation Reform Act of 1995. Such forward-looking statements
include but are not limited to statements regarding the
expectations and plans for clinical trials evaluating TG-1701 as
monotherapy and in combination with UKONIQ® (umbralisib) and
ublituximab (U2), the availability of results from those trials,
and the potential of TG-1701 as a treatment for CLL.
In addition to the risk factors identified from time to time in
our reports filed with the U.S. Securities and Exchange
Commission, factors that could cause our actual results to differ
materially are the following: the risk that interim, top-line, or
other early clinical trial results, including the clinical studies
evaluating TG-1701 in combination with U2, will not be reproduced
in final data sets or in future studies; the risk that the safety
profile observed with TG-1701 as monotherapy and in combination
with U2, may change as additional patients are exposed for longer
durations; the risk that TG-1701 as monotherapy or in combination
with U2 will not prove to be safe and efficacious; the
uncertainties inherent in research and development; the risk that
the ongoing COVID-19 pandemic and associated government control
measures have an adverse impact on our research and development
plans or commercialization efforts; and the risk that preclinical
findings will not be validated in clinical trials. 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 and in 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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Investor RelationsEmail:
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Media Relations:Email:
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