National Institutes of Health (NIH) Awards Research Grant of $2.59 Million to University of Pittsburgh for Diabetes Gene Ther...
July 21 2020 - 08:17AM
Business Wire
Grant to fund ongoing preclinical research for
important proof-of-principle non-human studies in preparation for
human gene therapy clinical trials
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 Dr. George K. Gittes, MD of the University of
Pittsburgh, the lead researcher that developed the Company’s
potentially curative diabetes gene therapy, was awarded a grant of
$2.59 million from the National Institutes of Health (“NIH”)
National Institute of Diabetes and Digestive and Kidney Diseases.
The grant will assist Dr. Gittes’s development for his research
project titled, “Alpha Cell Conversion to Beta Cells in Non-human
Primates” and will build upon his accumulating groundbreaking gene
therapy work toward finding a cure for diabetes. In this project,
Dr. Gittes’ research team will conduct important proof-of-principle
studies in non-human primates as the last steps in preparation for
human gene therapy clinical trials. This technology is the subject
of an exclusive license agreement entered into between Genprex and
the University of Pittsburgh in February of 2020.
“We are excited to receive this funding to support our research
in diabetic primates as we move toward human clinical trials,” said
Dr. George Gittes, Co-Scientific Director and Professor of Surgery
at the UPMC (University of Pittsburgh Medical Center) Children’s
Hospital of Pittsburgh and the lead researcher behind the diabetes
gene therapy. “We saw encouraging data in our preclinical mice
studies, where the gene therapy reprogrammed pancreatic cells to
restore normal blood glucose levels in diabetic mice for
approximately four months, which could translate to decades in
humans. More recently, preliminary results in non-human primates
(monkeys) has also been very promising.”
Dr. Gittes’ gene therapy for diabetes, which Genprex refers to
as “GPX-002,” uses a novel infusion process comprised of an
endoscope and an adeno-associated virus (AAV) vector to deliver
Pdx1 and MafA genes to the pancreas. The genes express proteins
that 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.
Diabetes affects approximately 10 percent of the U.S.
population, or more than 34 million people. The diabetes gene
therapy could not only become a new treatment option for millions
of diabetes patients who need insulin replacement therapy, but it
holds the potential to provide long-term effectiveness, or may even
be a cure, for diabetic patients.
Dr. Gittes is the inventor of the gene therapy for diabetes, and
he is eligible to receive royalties on this technology in the
future.
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.
The project described in this press release is being supported
by the National Institute of Diabetes and Digestive And Kidney
Diseases of the National Institutes of Health under Award Number
R01DK120377. The content is solely the responsibility of the
authors and does not necessarily represent the official views of
the National Institutes of Health.
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 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 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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