Market Overview

Genprex Updates Agreement with University of Texas MD Anderson Cancer Center to Resume Patient Enrollment in Phase I/II Study Evaluating Oncoprex/Erlotinib Combination Therapy in Non-Small Cell Lung Cancer


(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

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

For more information, please visit or

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.

View Comments and Join the Discussion!