Genprex Receives USAN Approval of Non-Proprietary Name for Lead Drug Candidate
June 25 2020 - 8:17AM
Business Wire
Company executes on corporate communication
strategy and advances drug branding initiatives
Lead drug candidate for NSCLC now referred to
as quaratusugene ozeplasmid or GPX-001
Company rebrands use of Oncoprex™ name for
Nanoparticle Delivery Platform
Genprex, Inc. (“Genprex” or the “Company”) (Nasdaq: GNPX), a
clinical-stage gene therapy company developing potentially
life-changing technologies for patients with cancer and diabetes,
today announced that the United States Adopted Names (USAN) Council
has approved the non-proprietary name quaratusugene ozeplasmid for
GPX-001, formerly called Oncoprex™ immunogene therapy, the
Company’s lead drug candidate for non-small cell lung cancer
(NSCLC).
The USAN Council is responsible for selecting simple,
informative, and unique non-proprietary (generic) drug names. As a
part of Genprex’s corporate communication strategy and drug
nomenclature branding, the Company is also pursuing formal
proprietary brand name approval for its lead drug candidate,
GPX-001 (quaratusugene ozeplasmid). Obtaining regulatory approval
of these adopted drug names is a necessary step in securing
marketing approval.
In conjunction with the adoption of quaratusugene ozeplasmid as
the Company’s non-proprietary name for GPX-001, Genprex has
rebranded the naming of its unique, proprietary, non-viral
nanoparticle delivery system, now referred to as its Oncoprex™
Nanoparticle Delivery Platform, which is the vehicle used to
deliver its oncology platform technologies.
“The USAN’s adoption of our non-proprietary name is another step
toward advancing our lead drug candidate, GPX-001 for non-small
cell lung cancer, toward commercialization,” said Rodney Varner,
Chairman and Chief Executive Officer of Genprex. “We look forward
to the adoption and rollout of a brand name for this drug as we
continue to move along the development pathway. In the meantime,
we’ve focused our branding efforts on our proprietary, non-viral
nanoparticle delivery system with our recognized Oncoprex™ name. We
believe this delivery system is a significant differentiator for
GPX-001, as well as an important platform delivery system that
could be used for additional drug candidates.”
As a part of the rollout of its newly adopted nomenclature and
to also include its gene therapy drug candidate for diabetes,
referred to as GPX-002, the Company has completed an overhaul of
its website, fact sheet and pipeline. For more information, please
visit www.genprex.com.
About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company
developing potentially life-changing technologies for patients with
cancer and diabetes. Genprex’s technologies are designed to
administer disease-fighting genes to provide new treatment options
for large patient populations with cancer and diabetes who
currently have limited treatment options. Genprex works with
world-class institutions and collaborators to in-license and
develop drug candidates to further its pipeline of gene therapies
in order to provide novel treatment approaches. The Company’s lead
product candidate, GPX-001 (quaratusugene ozeplasmid), is being
evaluated as a treatment for non-small cell lung cancer (NSCLC).
GPX-001 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. GPX-001 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
GPX-001 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 GPX-001, alone and in combination with
targeted therapies and/or immunotherapies, and whether our other
potential product candidates, including our gene therapy in
diabetes, advance into clinical trials; the success of our
strategic partnerships, including those relating to manufacturing
of our products; the timing and success at all of obtaining FDA
approval of GPX-001 and our other potential product candidates
including whether we receive fast track or similar regulatory
designations; costs associated with developing our product
candidates and whether patents will ever be issued under patent
applications that are the subject of our license agreements. 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.
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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
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