Genprex & University of Pittsburgh Sign Exclusive License Agreement for Potentially Curative Gene Therapy Candidate for Diabe...
12 February 2020 - 12:17AM
Business Wire
- Company licenses patented diabetes gene therapy technology
designed by researchers at the University of Pittsburgh
- Results from in vivo animal studies indicate that normal
glucose levels in the blood may be restored for an extended period
of time
- Company plans to partner for the clinical development and
commercialization of this therapy in the U.S. and
internationally
Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a
clinical-stage gene therapy company developing potentially
life-changing technologies for patients with cancer and other
serious diseases, today announced that it signed an exclusive
license agreement with the University of Pittsburgh for a diabetes
gene therapy that may have the potential to cure Type 1 and Type 2
diabetes, which together currently affect approximately 30.3
million people in the U.S, or 9 percent of the U.S. population.
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Genprex’s licensed diabetes gene therapy
technology works to reprogram alpha cells in the pancreas into
beta-like cells, restoring their function, thereby replenishing
levels of insulin. Image source: Osipovich, Anna & Magnuson,
Mark. (2018). Alpha to Beta Cell Reprogramming: Stepping toward a
New Treatment for Diabetes. Cell Stem Cell. 22. 12-13.
10.1016/j.stem.2017.12.012. (Graphic: Business Wire)
The diabetes gene therapy, which was developed by lead
researcher and Harvard graduate, Dr. George Gittes, at the Rangos
Research Center at UPMC Children’s Hospital of Pittsburgh, works by
reprogramming beta cells in the pancreas to restore their function,
thereby replenishing levels of insulin. The novel infusion process
uses an endoscope and an adeno-associated virus (AAV) vector to
deliver Pdx1 and MafA genes to the pancreas. The proteins these
genes express transform alpha cells in the pancreas into functional
beta-like cells, which can produce insulin but are distinct enough
from beta cells to evade the body’s immune system.
The diabetes gene therapy has been tested in vivo in mice and
nonhuman primates. In studies of diabetic mice, the gene therapy
approach restored normal blood glucose levels for an extended
period of time, typically around four months. According to Dr.
Gittes, the duration of restored blood glucose levels in mice could
translate to decades in humans. Following preclinical studies, Dr.
Gittes and his team plan to begin a Phase I clinical trial in
diabetic patients, which could be the first-ever gene therapy
tested in humans for diabetes.
“One of the biggest advantages of this gene therapy is that it
could eliminate the need for insulin replacement therapy for
diabetic patients,” said Dr. Gittes. “Lifting this huge burden for
the millions of patients who must continuously monitor blood
glucose levels and inject insulin daily would be a breakthrough in
modern medicine. This therapy has the potential to truly disrupt
the diabetes market.”
Genprex will add this exciting technology to its research and
development pipeline, diversifying its portfolio and expanding its
clinical development programs. The company will continue its focus
on developing its immunogene therapies for cancer, including
Oncoprex™ immunogene therapy, its lead drug candidate for non-small
cell lung cancer, in parallel with development of the new diabetes
gene therapy.
“We are excited to announce the licensing agreement with The
University of Pittsburgh, and we look forward to working with Dr.
Gittes and his team to develop this groundbreaking treatment for
diabetes,” said Rodney Varner, Genprex’s Chairman and Chief
Executive Officer. “At Genprex, we have always put patient needs
first, focusing on ways to bring new treatment options to patient
populations who have large unmet medical needs. We believe this
diabetes gene therapy may potentially become a new treatment option
for the millions of diabetes patients who now must take insulin
replacement therapy, and it may be effective for patients who do
not benefit sufficiently from that therapy. Even more moving, the
diabetes gene therapy could hold the potential to provide long term
effectiveness, or even be a cure, for diabetes patients.”
Genprex plans to pursue potential partnerships for the
development of this therapy globally and in the U.S.
According to the American Diabetes Association, more than 30
million Americans have diabetes, and approximately 1.5 million
Americans are diagnosed with diabetes every year. Diabetes patients
have the continuous burden of checking and monitoring their blood
glucose levels and injecting insulin on a daily basis. Without
effective management of diabetes, patients are at risk of stroke,
hyperglycemia, cardiovascular disease, diabetic ketoacidosis and
extremity amputation. Diabetes is the seventh leading cause of
death in the U.S.
About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company
developing potentially life-changing technologies for patients with
cancer and other serious diseases. Genprex’s technologies are
designed to administer disease-fighting genes to provide new
treatment options for large patient populations with cancer and
other serious diseases 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 for patients with cancer and other serious diseases. The
company’s lead product candidate, Oncoprex™ immunogene therapy for
non-small cell lung cancer (NSCLC), uses the company’s unique,
proprietary platform which delivers 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. In January 2020, the FDA granted Fast
Track Designation for Oncoprex in combination with AstraZeneca’s
Tagrisso® for the treatment of NSCLC. For more information, please
visit the company’s website 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 the licensed gene therapy on diabetes and the effect
of Genprex’s other product candidates, alone and in combination
with other therapies, on cancer, as well as Genprex’s ongoing and
planned preclinical and clinical studies and potential
partnerships. Risks that contribute to the uncertain nature of the
forward-looking statements include risks relating to the effects of
the safety and effectiveness of the licensed gene therapy and of
Genprex’s other product candidates, alone and in combination with
other therapies, as well as the success of Genprex’s ongoing and
planned preclinical and clinical studies and the success of
Genprex’s efforts in concluding potential partnering arrangements
for product development and commercialization. Other risks and
uncertainties associated with Genprex and its product candidates
are described more fully under the caption “Risk Factors” and
elsewhere in Genprex’s 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. Genprex undertakes 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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