Genprex Updates Agreement with University of Texas MD Anderson Cancer Center to Resume Patient Enrollment in Phase I/II Study...
August 02 2018 - 8:30AM
Business Wire
Genprex, Inc. (NASDAQ:GNPX), a clinical stage gene therapy
company developing a new approach to treating cancer based upon a
novel proprietary technology platform, today announced that it has
amended its agreement with The University of Texas MD Anderson
Cancer Center to resume patient enrollment in its Phase I/II
clinical trial evaluating the combination of the company’s
investigational drug Oncoprex™ and erlotinib (Tarceva®) for the
treatment of Stage IV non-small cell lung cancer (NSCLC).
Oncoprex is a TUSC2 gene encapsulated in a positively charged
nanovesicle made from lipid molecules and injected intravenously,
which can specifically target cancer cells and insert wild-type
TUSC2 into cellular DNA, effectively increasing expression of the
TUSC2 protein and promoting tumor cell death.
Previously announced interim data from nine patients from the
Phase II portion of this Phase I/II clinical trial showed a disease
control rate of 78%, with seven out of nine patients achieving
stable disease or better, including one complete response. In a
previous Phase I clinical trial at MD Anderson evaluating Oncoprex
as a monotherapy, five of 23 patients with late-stage NSCLC
achieved stable disease or better, with one durable metabolic
response.
“We look forward to completing the Oncoprex/erlotinib trial and
expanding the study of Oncoprex in combination with other targeted
and immunotherapies in the future,” said Rodney Varner, Chairman
and Chief Executive Officer of Genprex. “We believe the data from
the more than 50 late-stage NSCLC patients treated to date provide
persuasive evidence of Oncoprex’s anti-tumor effects and favorable
safety profile.”
A subset of NSCLC patients (approximately 10% of NSCLC patients
of North American and European descent and approximately 30% to 50%
of NSCLC patients of Asian descent) carry an EGFR mutation that
makes their tumors sensitive to tyrosine kinase inhibitors, or
TKIs, such as erlotinib. However, even for these patients, tumor
resistance to TKIs frequently develops within two years, resulting
in eventual disease progression. While next generation TKIs show
promise in targeting resistant EGFR positive tumors that carry a
mutation known as T790M, only about one-half of EGFR
positive patients (5% to 7.5% of all NSCLC patients of North
American and European descent and 15% to 25% of NSCLC patients of
Asian descent) carry the T790M mutation. This leaves a significant
majority of NSCLC patients—those who are EGFR negative and those
who are EGFR positive but have become resistant to erlotinib and do
not have the T790M mutation—without a targeted therapy for their
cancer.
Combination therapies targeting multiple anti-cancer pathways
represent a promising approach to achieving greater response rates,
and may also allow the expanded use of targeted therapies and
immunotherapies in a larger population of cancer patients who are
not currently candidates for these treatments.
About Lung Cancer
According to the World Health Organization, lung cancer is the
leading cause of cancer deaths worldwide, and is the second most
common type of cancer. Each year, there are over 1.8 million new
lung cancer cases and 1.6 million deaths from lung cancer
worldwide, and in the United States there are over 225,000 new
cases and more than 150,000 deaths from lung cancer per year. NSCLC
represents 80% of all lung cancers. According to a 2016 American
Cancer Society report, the five-year survival rate for Stage IV
(metastatic) NSCLC is about 1%, and overall survival for lung
cancer has not improved appreciably in the last 25 years.
About Genprex
Genprex, Inc. is a clinical stage gene therapy company
developing a new approach to treating cancer, based upon a novel
proprietary technology platform, including Genprex’s initial
product candidate, Oncoprex™ immunogene therapy for non-small cell
lung cancer (NSCLC). 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.
Oncoprex has a multimodal mechanism of action whereby it interrupts
cell signaling pathways that cause replication and proliferation of
cancer cells, re-establishes pathways for apoptosis, or programmed
cell death, in cancer cells, and modulates the immune response
against cancer cells. Oncoprex has also been shown to block
mechanisms that create drug resistance.
For more information, please
visit www.genprex.com or www.facebook.com/genprexinc.
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 TUSC2 and Oncoprex on cancer, alone or in combination
with other drugs, whether and if so, when our clinical trials might
be undertaken, expanded or completed, the safety of Oncoprex, the
services we expect to receive from MD Anderson and the effect of
those services on the development of Oncoprex. Risks that
contribute to the uncertain nature of the forward-looking
statements include the presence and level of TUSC2’s and Oncoprex’s
effect on cancer, alone or in combination with other drugs, the
safety of Oncoprex, MD Anderson’s ability to provide services to us
and our ability to utilize MD Anderson’s services, the ability of
MD Anderson’s services to influence the development of Oncoprex, as
well as the timing and success of our clinical trials and planned
clinical trials of TUSC2 and Oncoprex and our other potential
product candidates and the timing and success of obtaining FDA
approval of Oncoprex and our other potential product candidates.
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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version on businesswire.com: https://www.businesswire.com/news/home/20180802005224/en/
Media:ICR HealthcareJames Heins,
203-682-8251James.Heins@icrinc.comorInvestors:ICR
HealthcareStephanie Carrington,
646-277-1282Stephanie.Carrington@icrinc.com
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