Genprex Provides Clinical and Corporate Update for Third Quarter 2018
November 20 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 a clinical
and corporate update, and the filing of quarterly results for the
third quarter ended September 30, 2018 on Form 10-Q with the
Securities and Exchange Commission.
Rodney Varner, Chairman and CEO, remarked, “Over the past
quarter, we have taken steps to advance our clinical development
activities. We extended our ability to strengthen our patent
protection for our TUSC2 gene platform, expanded our collaborations
and augmented our team. Most notably, we added Jan Stevens, RN,
whose expertise in clinical operations will be invaluable as we
look to expand our Phase I/II clinical study evaluating Oncoprextm
in combination with Tarceva® for treatment of Stage IV or recurrent
non-small cell lung cancer (NSCLC).”
Julien L. Pham, MD, MPH, President and Chief Operating Officer,
stated, “We are confident in our choice of Aldevron as a plasmid
manufacturing partner and look forward to working with them to
continue our clinical trials of our immunogene therapy Oncoprex™
for the treatment on non-small cell lung cancer.”
Clinical Development and Corporate Update
- Entered into amendments with The
University of Texas MD Anderson Cancer Center (MD Anderson) to
extend the terms of two option agreements between Genprex and MD
Anderson pertaining the use of TUSC2, the active agent in Genprex’s
lead product candidate Oncoprex, in combination with
immunotherapies and the development and the use of biomarkers to
predict patient response to TUSC2 therapy.
- Entered into an agreement with
Aldevron, a leading contract manufacturing organization, to supply
TUSC2 (Tumor Suppressor Candidate 2) plasmid DNA for use in
Genprex’s clinical development program evaluating Oncoprex for the
treatment of NSCLC.
- Entered into agreements with additional
contract manufacturing organizations to assist with manufacturing
scale-up and transfer of manufacturing processes from manufacturing
facilities of the University of Texas MD Anderson Cancer Center to
commercial facilities.
- Appointed Jan Stevens, RN as Vice
President of Clinical Operations in October 2018. Ms. Stevens
joined the Company’s Cambridge office to lead clinical operations
and support corporate development efforts, focusing on expanding
research and clinical development opportunities, including the
expansion of Genprex’s Oncoprex + Tarceva combination trial across
multiple US sites.
Third Quarter 2018 Financial Update
Genprex’s research and development expense was $489,689 for the
three months ended September 30, 2018 as compared to $55,517
for the three months ended September 30, 2017. The increase in
the current year period was driven entirely by increased R&D
and commercialization activities associated with the development of
our drug candidate and the progression of our Phase I/II clinical
trial at MD Anderson.
Genprex had a cash position of $10.3 million as of September 30,
2018.
Forward Looking StatementsStatements contained in this
press release that are not statements of historical facts are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Because these statements
are subject to risks and uncertainties, the 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 on cancer,
either alone or in combination with other drugs, the effect of
methods for predicting patients’ response to therapy, the products
and services we expect to receive from Aldevron and contract
manufacturing organizations and the effect of those products and
services on the development of Oncoprex™, statements about
Genprex’s business plans, statements about the timing and success
of the Company’s existing and planned clinical trials, statements
about the development of the Company’s current and potential future
product candidates and statements about the Company’s plans to seek
regulatory approval of its product candidates. Risks that
contribute to the uncertain nature of the forward-looking
statements include: the presence and level of TUSC2’s effect on
cancer; the ability of Aldevron and contract manufacturing
organizations to provide products and services to the Company and
the Company’s ability to utilize those products and services; the
ability of the products and services of Aldevron and contract
manufacturing organizations to influence the development of
Oncoprex™; the effect on cancer of combining TUSC2 with
immunotherapies, EGFR inhibitors, or other drugs; whether or not
Genprex will be able to negotiate and execute final technology
license agreements under the extended options with MD Anderson; the
nature and scope of protection ultimately provided under any of the
licensed patents and patent applications should such technology
license agreements be executed; the timing, success and cost of the
Company’s clinical trials and planned clinical trials of TUSC2 and
Oncoprex and other potential product candidates; the timing and
success of obtaining FDA approval of Oncoprex and the Company’s
other potential product candidates; the success, cost and timing of
the Company’s product candidate development activities; the
Company’s ability to execute on its strategy; regulatory
developments in the United States and foreign countries; and the
Company’s estimates regarding expenses, future revenue and capital
requirements. These and other risks and uncertainties 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 does not undertake any obligation to update these
statements to reflect any events that occur or facts that exist
after the date on which the statements were made.
About Genprex, Inc.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. Visit the company’s web
site at www.genprex.com or follow Genprex on Twitter at
https://twitter.com/genprex and Facebook at
https://www.facebook.com/genprexinc/.
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Investors:Stephanie CarringtonICR
Healthcare646-277-1282Stephanie.Carrington@icrinc.com
Media:James HeinsICR
Healthcare203-682-8251James.Heins@icrinc.com
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