Genprex Receives Conditional FDA Acceptance of Proprietary Name REQORSA™ for Lead Drug Candidate for Treatment of Non-Small...
October 29 2020 - 8:16AM
Business Wire
Approval of new name marks important branding
milestone and aligns with the program’s overall progress
REQORSA immunogene therapy uses the company’s
unique, proprietary ONCOPREX™ nanoparticle delivery system to
deliver cancer-fighting genes
FDA granted Fast Track Designation for REQORSA
in combination with AstraZeneca’s Tagrisso® for the treatment of
non-small cell lung cancer earlier this year
Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a
clinical-stage gene therapy company focused on developing
life-changing therapies for patients with cancer and diabetes,
today announced that the U.S. Food and Drug Administration (FDA)
has conditionally accepted the proprietary name REQORSA™ for its
lead drug candidate in development for the treatment of non-small
cell lung cancer, known previously by the laboratory designation
GPX-001.
The name REQORSA (pronounced “re-KORE-suh”), was developed in
accordance with FDA’s guidance for the submission and evaluation of
proprietary names. The Company selected the name based on
comprehensive and disciplined review of name candidates, including
a research study of healthcare practitioners across the U.S. to
ensure accurate prescription and safety interpretation of the
name.
“We are very pleased to receive FDA’s conditional acceptance of
our proprietary name, REQORSA, which is a necessary step toward
being able to market our lead drug candidate for non-small cell
lung cancer,” said Rodney Varner, President and Chief Executive
Officer of Genprex. “This name approval also marks an important
milestone in our overall branding strategy, giving us a unique,
easily understood name people can associate with the Genprex brand
and mission.”
Genprex will resubmit its proprietary name for FDA final review
upon completion of all required clinical trials and prior to the
submission of a Biologics License Application. Final approval of
the REQORSA brand name is conditional on FDA approval of the
product candidate.
REQORSA uses the company’s unique, proprietary ONCOPREX®
nanoparticle delivery system, which delivers cancer-fighting genes
by encapsulating them into nanoparticles, which are then
administered intravenously and taken up by tumor cells where they
express proteins that are missing or found in low quantities. In
January 2020, the FDA granted Fast Track Designation for REQORSA in
combination with AstraZeneca’s Tagrisso® for the treatment of
non-small cell lung cancer.
About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company focused
on developing life-changing therapies for patients with cancer and
diabetes. Genprex’s technologies are designed to administer
disease-fighting genes to provide new therapies for large patient
populations with cancer and diabetes who currently have limited
treatment options. Genprex works with world-class institutions and
collaborators to develop drug candidates to further its pipeline of
gene therapies in order to provide novel treatment approaches. The
Company’s lead product candidate, REQORSA™ immunogene therapy drug
(quaratusugene ozeplasmid), is being evaluated as a treatment for
non-small cell lung cancer (NSCLC). REQORSA has a multimodal
mechanism of action that has been shown to interrupt cell signaling
pathways that cause replication and proliferation of cancer cells;
re-establish pathways for apoptosis, or programmed cell death, in
cancer cells; and modulate the immune response against cancer
cells. REQORSA has also been shown to block mechanisms that create
drug resistance. In January 2020, the U.S. Food and Drug
Administration granted Fast Track Designation for REQORSA for NSCLC
in combination therapy with osimertinib (AstraZeneca’s Tagrisso®)
for patients with EFGR mutations whose tumors progressed after
treatment with osimertinib alone. For more information, please
visit the Company’s web site at www.genprex.com or follow Genprex
on Twitter, Facebook and LinkedIn.
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such
statements include, but are not limited to, statements regarding
the effect of Genprex’s product candidates, alone and in
combination with other therapies, on cancer and diabetes, regarding
potential, current and planned clinical trials, regarding the
Company’s future growth and financial status and regarding our
commercial partnerships and intellectual property licenses. Risks
that contribute to the uncertain nature of the forward-looking
statements include the presence and level of the effect of our
product candidates, alone and in combination with other therapies,
on cancer; the timing and success of our clinical trials and
planned clinical trials of REQORSA™, alone and in combination with
targeted therapies and/or immunotherapies, and whether our other
potential product candidates, including GPX-002, our gene therapy
in diabetes, advance into clinical trials; the success of our
strategic partnerships, including those relating to manufacturing
of our product candidates; the timing and success at all of
obtaining FDA approval of REQORSA and our other potential product
candidates including whether we receive or benefit from fast track
or similar regulatory designations; costs associated with
developing our product candidates, whether we identify and succeed
in acquiring other technologies and whether patents will ever be
issued under patent applications that are the subject of our
license agreements or otherwise. These and other risks and
uncertainties are described more fully under the caption “Risk
Factors” and elsewhere in our filings and reports with the United
States Securities and Exchange Commission. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. We undertake no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201029005330/en/
Genprex, Inc. (877) 774-GNPX (4679)
Investor Relations GNPX Investor Relations (877) 774-GNPX
(4679) ext. #2 investors@genprex.com
Media Contact Genprex Media Relations Kalyn Dabbs (877)
774-GNPX (4679) ext. #3 media@genprex.com
Genprex (NASDAQ:GNPX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Genprex (NASDAQ:GNPX)
Historical Stock Chart
From Apr 2023 to Apr 2024