Genprex Provides Clinical and Corporate Update for Second Quarter 2018
August 15 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
second quarter ended June 30, 2018 on Form 10-Q with the Securities
and Exchange Commission.
Rodney Varner, Chairman and CEO, remarked, “We have made
significant progress in recent months to advance the development of
Oncoprex™ for treatment of non-small cell lung cancer (NSCLC),
including engaging collaborators with expertise and other resources
necessary for important pre-clinical and clinical services. We also
obtained an additional $10 million in capital, which provides
additional financial resources to position the Company to achieve
its critical milestones in its path toward developing and
commercializing Oncoprex. ”
Julien L. Pham, MD, MPH, President and Chief Operating Officer,
stated, “We are moving toward resuming enrollment in the Phase I/II
clinical evaluating the combination of Oncoprex™ and erlotinib
(Tarceva®) for the treatment of Stage IV non-small cell lung cancer
(NSCLC), adding an additional preclinical trial to study Oncoprex
in combination with immunotherapies, and progressing with
manufacturing scale-up.”
Clinical Development Highlights (May 2018 to present)
- Selected Accenture to provide clinical
data management services to help accelerate the clinical
development of Genprex’s lead drug candidate, Oncoprex™.
- Entered an agreement to use
WIRB-Copernicus Group (WCG) to provide site selection and
feasibility services, including Institutional Review Board (IRB)
and Institutional Biosafety Committee (IBC) oversight for new
clinical trial sites that Genprex anticipates adding to participate
in its Phase I/II clinical trial evaluating the combination of
OncoprexTM and erlotinib (Tarceva®) in NSCLC.
- Selected 4Clinics as a CRO to provide
clinical and regulatory support for the clinical development
program in the form of biostatistics, statistical programming and
analysis, as well as medical and scientific writing for the Phase
I/II clinical trial.
- Entered an agreement with The
University of Texas MD Anderson Center under which Genprex is
sponsoring a pre-clinical study intended to develop a novel
therapeutic approach for the treatment of cancer using a
combination of the multifactorial tumor suppressor gene TUSC2 and
immunotherapy, including the immune checkpoint inhibitors anti-PD1
and/or anti CTLA-4. This study will include the identification of
biomarkers to predict the response to TUSC2-immunotherapy
combinations.
- Amended its agreement with The
University of Texas MD Anderson Cancer Center to resume patient
enrollment in its Phase I/II trial evaluating the combination of
Oncoprex™ and erlotinib (Tarceva®) for the treatment of Stage IV
non-small cell lung cancer (NSCLC).
Corporate Update
- Entered an agreement with the
University of Texas at Austin Dell Medical School to establish
executive offices at the school’s Health Discovery Building,
joining the WorkSpaces @ Texas Health CoLab. WorkSpaces @ Texas
Health CoLab is designed to identify and support people and
companies that share Dell Medical School’s commitment to improving
health outcomes to patients and reducing healthcare costs.
- Established offices in Cambridge, MA,
where Dr. Julien Pham, President and COO will oversee the clinical
development of Genprex’s lead drug candidate, Oncoprex™.
- Completed a $10 million private
placement.
Forward Looking Statements
Statements 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 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, statements about the Company’s plans to seek
regulatory approval of its product candidates, and statements about
the services the Company expects to receive from its development
partners 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 success, cost and timing of
the Company’s product candidate development activities and current
and planned clinical trials; the Company’s ability to execute on
its strategy; regulatory developments in the United States and
foreign countries; the Company’s estimates regarding expenses,
future revenue and capital requirements; and the ability of the
Company’s development partners to provide services to the Company
and the Company’s ability to utilize those services, and the
ability of those services to influence the development of Oncoprex.
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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version on businesswire.com: https://www.businesswire.com/news/home/20180815005199/en/
Investors:ICR HealthcareStephanie Carrington,
646-277-1282Stephanie.Carrington@icrinc.comorMedia:ICR
HealthcareJames Heins, 203-682-8251James.Heins@icrinc.com
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