Genprex Receives U.S. FDA Fast Track Designation for Gene Therapy that Targets Lung Cancer
January 21 2020 - 8:00AM
Business Wire
Lung cancer is the world’s leading cause of
cancer deaths
Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a
clinical-stage gene therapy company utilizing a unique, non-viral
proprietary platform designed to deliver tumor suppressor genes to
cancer cells, today announced that the U.S Food and Drug
Administration (FDA) has granted Fast Track Designation for
Genprex’s Oncoprex™ immunogene therapy in combination with EGFR
inhibitor osimertinib (AstraZeneca’s Tagrisso®, which had worldwide
sales in 2018 of $1.86 billion, $2.31 billion in the first 9 months
of 2019 and is currently AstraZeneca’s highest grossing product)
for the treatment of non-small cell lung cancer (NSCLC) patients
with EFGR mutations that progressed after treatment with
osimertinib alone. Oncoprex is comprised of the TUSC2 (Tumor
Suppressor Candidate 2) gene complexed with a lipid nanoparticle.
TUSC2 is the active agent in Oncoprex.
Genprex has treated more than 50 lung cancer patients with
Oncoprex in Phase I and II clinical trials. The company believes
the data from these trials are encouraging as to both safety and
efficacy.
“Genprex is excited to receive this important FDA designation,”
said Rodney Varner, Chairman and Chief Executive Officer of
Genprex. “In addition to potentially facilitating and expediting
our pathway to approval, we believe that this FDA designation
validates our plan to commercialize Oncoprex immunogene therapy in
combination with EGFR inhibitors for the treatment of lung cancer.
We hope that Fast Track Designation helps us bring our gene therapy
to patients more rapidly and that our unique gene therapy platform
is more widely recognized for its potential in cancer
treatment.”
FDA may award Fast Track Designation if it determines that a
drug demonstrates the potential to address unmet medical needs for
a serious or life-threatening disease or condition. This provision
is intended to facilitate development and expedite review of drugs
to treat serious and life-threatening conditions so that an
approved product can reach the market expeditiously.
Fast Track drug candidates must show advantages over available
therapies, such as superior effectiveness, avoiding serious side
effects, improving diagnosis and outcome, decreasing significant
toxicity, and the ability to address public health needs.
Fast Track Designation recipients may also be eligible for
accelerated approval or rolling review of the recipient’s Biologics
License Application (BLA). In addition, Fast Track product
candidates could be eligible for priority review if supported by
clinical data at the time of BLA submission.
The initial disease indication for Oncoprex is NSCLC. Lung
cancer is the world’s leading cause of cancer death, taking more
lives each year than colon, breast and prostate cancers combined.
Each year, there are more than 2 million new lung cancer cases and
1.7 million deaths from lung cancer worldwide. In the United
States, there are more than 228,000 new cases of lung cancer and
more than 142,000 deaths from lung cancer each year. NSCLC
represents 84 percent of all lung cancers, and the five-year
relative survival rate for metastatic lung cancer is less than 5
percent.
Genprex is preparing to initiate a Phase I/II clinical trial
evaluating Oncoprex in combination with osimertinib, as well as a
new Phase I clinical trial evaluating Oncoprex in combination with
a checkpoint inhibitor.
For more information on the U.S. FDA’s Fast Track Designation,
please visit the FDA’s Fast Track webpage.
About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company
developing potentially life-changing technologies for cancer
patients based upon a unique proprietary technology platform.
Genprex’s platform technologies are designed to administer
cancer-fighting genes by encapsulating them into nanoscale hollow
spheres called nanovesicles, which are then administered
intravenously and taken up by tumor cells where they express
proteins that are missing or found in low quantities. The company’s
lead product candidate, Oncoprex™ immunogene therapy for non-small
cell lung cancer (NSCLC), has a multimodal mechanism of action
whereby it 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. Oncoprex has
also been shown to block mechanisms that create drug resistance.
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 effects of Oncoprex, or Oncoprex in combination with
immunotherapies, and Oncoprex combined with immunotherapies and
chemotherapies, on cancer, as well as the potential benefits of
Fast Track Designation to us. Risks that contribute to the
uncertain nature of the forward-looking statements include risks
relating to the presence and level of the effects of Oncoprex,
alone and in combination with immunotherapies and chemotherapies,
on cancer, the safety and effectiveness of Oncoprex, alone and in
combination with immunotherapies and chemotherapies, as well as the
timing and success of our clinical trials and planned clinical
trials of Oncoprex™ and our other potential product candidates.
Other risks and uncertainties associated with Genprex and its lead
product candidate Oncoprex 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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