TG Therapeutics Confirms Registration Path for Umbralisib in Marginal Zone Lymphoma Following FDA Meeting
June 11 2019 - 6:58AM
TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the
Company has confirmed its path to submit umbralisib for
accelerated approval based on data from the marginal zone lymphoma
(MZL) cohort of the UNITY-NHL Phase 2b trial. The Company recently
had a productive Breakthrough Therapy Designation (BTD) meeting
with the U.S. Food and Drug Administration (FDA) to
discuss the MZL submission strategy. Based on this meeting, the
Company anticipates initiating a New Drug Application (NDA)
submission for patients with previously treated MZL by year-end
2019.
Michael S. Weiss, Executive Chairman and Chief Executive Officer
of TG Therapeutics stated, "Marginal zone lymphoma
is an incurable disease for which there are limited available
therapies. As a non-chemotherapy, orally active, once daily
medication, we believe umbralisib could represent a meaningful new
treatment option for patients with MZL. Defining a path to a
regulatory submission for umbralisib for this patient population
marks an important step forward for the Company and we appreciate
the guidance we have received from the FDA. We look forward to
beginning the NDA process later this year, as we work expeditiously
to bring umbralisib to the patients who need it.” Mr. Weiss
continued, “With our MZL NDA moving forward, and Phase 3 read-outs
for CLL and MS targeted over approximately the next six to twelve
months, we believe TG is well positioned for success.”
ABOUT THE UNITY-NHL PHASE 2b STUDY—MARGINAL ZONE LYMPHOMA
COHORT The multicenter, open-label, UNITY-NHL Phase
2b study - Marginal Zone Lymphoma (MZL) cohort was designed to
evaluate the safety and efficacy of single agent umbralisib,
in patients with MZL who have received at least one prior anti-CD20
regimen. The primary endpoint is overall response rate (ORR) as
determined by central Independent Review Committee (IRC)
assessment. The MZL cohort completed enrollment in August
2018 with a total of 69 patients enrolled and receiving at
least one dose of umbralisib. In February of 2019, the Company
announced that the MZL cohort met its primary endpoint
of ORR as determined by central IRC for all treated
patients (n=69). While the study has already met the Company’s
target guidance of 40-50% ORR, the final analysis
of ORR will be conducted when all treated patients have
had at least 9 cycles (cycle = 28 days) of follow-up. Secondary
endpoints include safety, duration of response, and
progression-free survival (PFS). ABOUT BREAKTHROUGH
THERAPY DESIGNATION The Company announced in January of
2019 that the U. S. Food and Drug Administration (FDA)
granted Breakthrough Therapy Designation (BTD) for umbralisib for
the treatment of adult patients with MZL who have received at
least one prior anti-CD20 regimen. The FDA’s Breakthrough
Therapy Designation is intended to expedite the development and
review of a drug candidate that is planned to treat a serious or
life-threatening disease or condition and preliminary clinical
evidence indicates that the drug may demonstrate substantial
improvement on one or more clinically significant endpoints over
available therapies.
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 developing multiple therapies targeting hematological
malignancies and autoimmune diseases. Ublituximab (TG-1101) is a
novel, glycoengineered monoclonal antibody that targets a specific
and unique epitope on the CD20 antigen found on mature
B-lymphocytes. TG Therapeutics is also developing
umbralisib (TGR-1202), an oral, once-daily inhibitor of PI3K-delta.
Umbralisib uniquely inhibits CK1-epsilon, which may allow it to
overcome certain tolerability issues associated with first
generation PI3K-delta inhibitors. Both ublituximab and umbralisib,
or the combination of which is referred to as "U2", are in Phase 3
clinical development for patients with hematologic malignancies,
with ublituximab also in Phase 3 clinical development for Multiple
Sclerosis. Additionally, the Company has recently brought into
Phase 1 clinical development, TG-1501, its anti-PD-L1 monoclonal
antibody, TG-1701, its covalently-bound Bruton’s Tyrosine Kinase
(BTK) inhibitor and TG-1801, its anti-CD47/CD19 bispecific
antibody. TG Therapeutics is headquartered in New
York City. Cautionary StatementSome of the
statements included in this press release may be 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 are the following: the risk
that the interim data (the “Interim Results”) from the UNITY-NHL
MZL cohort will not be reproduced when the final analysis is
conducted on all patients, including the risk that the final
results will demonstrate a lower ORR and/or enhanced toxicities,
which may not support a filing for accelerated approval; the risk
that even if the Interim Results are reproduced in the final
analysis of the UNITY-NHL MZL cohort or that the final results
otherwise meet the Company’s target ORR of 40-50%, that the final
results will still be insufficient to support a filing for
accelerated approval; the risk that umbralisib will not be accepted
for filing or receive accelerated approval based on data from the
UNITY-NHL MZL cohort even if the final results are deemed positive
by the Company and support a filing for accelerated approval; the
risk that duration of response or progression free survival data
from the UNITY-NHL cohort when available for all patients will not
be positive or supportive of accelerated approval; the risk that
safety issues will arise when the final safety data are cleaned and
analyzed for all patients in the UNITY-NHL MZL cohort; the risk
that the positive Interim Results from the UNITY-NHL MZL cohort
will not be reproduced in other cohorts of the UNITY-NHL study or
in other studies being conducted by the Company; the risk that our
belief that umbralisib has a differentiated safety profile will not
be shared by physicians or the FDA or will not be reproduced in the
final analysis of the UNITY-NHL MZL cohort, in other cohorts of the
UNITY-NHL study, in the UNITY-CLL study or in any other of our
on-going studies; the risk that the anticipated timeline for filing
an NDA for accelerated approval for patients with MZL based on
UNITY-NHL data and the timeline for data releases for UNITY-CLL and
ULTIMATE-MS trials will be delayed due to a variety of factors,
including, without limitation, available resources, program
reprioritization, slower than expected event rates for UNITY-CLL
and/or requests from FDA or foreign regulators; the risk that we
are not able to successfully and cost effectively complete all the
preclinical, clinical and CMC requirements necessary to support
accelerated approval. 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 A. Bosco Senior Vice President,
Corporate Communications TG Therapeutics, Inc. Telephone:
212.554.4351 Email: ir@tgtxinc.com
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