Clinical Advisory Board to Provide Strategy
for Advancing Preclinical Oncology Program in Mesothelioma
AUSTIN,
Texas, Sept. 19, 2024 /PRNewswire/ -- Genprex,
Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage
gene therapy company focused on developing life-changing therapies
for patients with cancer and diabetes, today announced the
formation of a Mesothelioma Clinical Advisory Board to support the
Company's preclinical mesothelioma oncology program. The Board is
comprised of four world-renown researchers from major research
institutions specializing in the treatment of mesothelioma.
"We continue to develop a robust research program around our
Reqorsa® Gene Therapy to expand its potential benefit to new
patient populations, and we are pleased to assemble a group of
highly respected physicians to assist in advancing our preclinical
program in mesothelioma," said Ryan
Confer, President and Chief Executive Officer at Genprex.
"This group of world class researchers will not only provide advice
and input to assist the Genprex team in moving forward our
potentially promising program in mesothelioma, but the formation of
this board underscores our continuous efforts to advance our
research programs in some of the most difficult to treat cancers
with patients who have limited treatment options or an unmet
medical need."
Expression of TUSC2 is downregulated in 84% of
mesotheliomas. Genprex collaborators at New York University Langone Health will present
additional positive preclinical data on TUSC2 for the treatment of
mesothelioma next month at the 2024 EORTC-NCI-AACR Symposium on
Molecular Targets and Cancer Therapeutics. TUSC2 is the tumor
suppressor gene used in Reqorsa® Gene Therapy (Quaratusugene
ozeplasmid). REQORSA consists of a TUSC2 gene expressing plasmid
encapsulated in non-viral lipid-based nanoparticles in
a lipoplex form (the Company's Oncoprex® Delivery
System), which has a positive charge. REQORSA is injected
intravenously and specifically targets cancer cells. REQORSA is
designed to deliver the functioning TUSC2 gene to negatively
charged cancer cells while minimizing uptake by normal tissue.
Laboratory studies conducted at MD Anderson show that the
uptake of TUSC2 in tumor cells in vitro after REQORSA treatment
was 10 to 33 times the uptake in normal cells.
According to the Center for Disease Control, mesothelioma is a
cancer that forms in the thin tissue that lines many internal
organs, called the mesothelium. The most common kind of
mesothelioma forms in the tissue around the lungs, called the
pleura. This is called pleural mesothelioma, which accounts for
80-90% of all mesothelioma diagnoses. Approximately 3,000 new cases
of mesothelioma are diagnosed each year in the U.S., and there are
approximately 2,500 mesothelioma-related deaths each year in the
U.S. The life expectancy for pleural mesothelioma is 18 months, and
the 3-year survival rate with treatment for pleural mesothelioma is
23%.
About Reqorsa® Gene Therapy
REQORSA (quaratusugene
ozeplasmid) for NSCLC and small-cell lung cancer (SCLC) consists of
the TUSC2 gene expressing plasmid encapsulated in non-viral
nanoparticles made from lipid molecules (Genprex's ONCOPREX®
Delivery System) with a positive electrical charge. REQORSA is
injected intravenously and specifically targets cancer cells, which
generally have a negative electrical charge. REQORSA is designed to
deliver the functioning TUSC2 gene to cancer cells while minimizing
their uptake by normal tissue. REQORSA has a multimodal mechanism
of action whereby it interrupts cell signaling pathways that cause
replication and proliferation of cancer cells, re-establishes
pathways for programmed cell death, or apoptosis, in cancer cells,
and modulates the immune response against cancer cells.
Genprex's strategy is to develop REQORSA in combination with
currently approved therapies and believes that REQORSA's unique
attributes position it to provide treatments that improve on these
current therapies for patients with NSCLC, SCLC, and possibly other
cancers.
About Genprex, Inc.
Genprex, Inc. is a clinical-stage
gene therapy company focused on developing life-changing therapies
for patients with cancer and diabetes. Genprex's technologies are
designed to administer disease-fighting genes to provide new
therapies for large patient populations with cancer and diabetes
who currently have limited treatment options. Genprex works with
world-class institutions and collaborators to develop drug
candidates to further its pipeline of gene therapies in order to
provide novel treatment approaches. Genprex's oncology program
utilizes its systemic, non-viral Oncoprex® Delivery System which
encapsulates the gene-expressing plasmids using lipid-based
nanoparticles in a lipoplex form. The resultant product is
administered intravenously, where it is taken up by tumor cells
that then express tumor suppressor proteins that were deficient in
the tumor. The Company's lead product candidate, Reqorsa® Gene
Therapy (quaratusugene ozeplasmid), is being evaluated in two
clinical trials as a treatment for NSCLC and SCLC. Each of
Genprex's lung cancer clinical programs has received a Fast Track
Designation from the FDA for the treatment of that patient
population, and Genprex's SCLC program has received an FDA Orphan
Drug Designation. Genprex's diabetes gene therapy approach is
comprised of a novel infusion process that uses an AAV vector to
deliver Pdx1 and MafA genes directly to the pancreas. In models of
Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas
into functional beta-like cells, which can produce insulin but may
be distinct enough from beta cells to evade the body's immune
system. In a similar approach, GPX-002 for Type 2 diabetes, where
autoimmunity is not at play, is believed to rejuvenate and
replenish exhausted beta cells.
Interested investors and shareholders are encouraged to sign up
for press releases and industry updates by visiting
the Company Website, registering for Email
Alerts and by following Genprex on Twitter, Facebook and
LinkedIn.
Cautionary Language Concerning 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. These forward-looking
statements are made on the basis of the current beliefs,
expectations and assumptions of management, are not guarantees of
performance and are subject to significant risks and uncertainty.
These forward-looking statements should, therefore, be considered
in light of various important factors, including those set forth in
Genprex's reports that it files from time to time with the
Securities and Exchange Commission and which you should review,
including those statements under "Item 1A – Risk Factors" in
Genprex's Annual Report on Form 10-K for the year ended
December 31, 2023.
Because forward-looking 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:
REQORSA's potential as a therapeutic treatment in mesothelioma;
Genprex's ability to advance the clinical development,
manufacturing and commercialization of its product candidates in
accordance with projected timelines and specifications; the timing
and success of Genprex's clinical trials and regulatory approvals;
the effect of Genprex's product candidates, alone and in
combination with other therapies, on cancer and diabetes; the
effects of any strategic research and development prioritization
initiatives, and any other strategic alternatives or other efforts
that Genprex takes or may take in the future that are aimed at
optimizing and re-focusing Genprex's diabetes, oncology and/or
other clinical development programs including prioritization of
resources, and the extent to which Genprex is able to implement
such efforts and initiatives successfully to achieve the desired
and intended results thereof; Genprex's future growth and financial
status, including Genprex's ability to maintain compliance
with the continued listing requirements of The Nasdaq Capital
Market and to continue as a going concern and to obtain capital to
meet its long-term liquidity needs on acceptable terms, or at all;
Genprex's commercial and strategic partnerships, including those
with its third party vendors, suppliers and manufacturers and their
ability to successfully perform and scale up the manufacture of its
product candidates; and Genprex's intellectual property and
licenses.
These forward-looking statements should not be relied upon as
predictions of future events and Genprex cannot assure you that the
events or circumstances discussed or reflected in these statements
will be achieved or will occur. If such forward-looking statements
prove to be inaccurate, the inaccuracy may be material. You should
not regard these statements as a representation or warranty by
Genprex or any other person that Genprex will achieve its
objectives and plans in any specified timeframe, or at all. You are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this press release.
Genprex disclaims any obligation to publicly update or release any
revisions to these forward-looking statements, whether as a result
of new information, future events or otherwise, after the date of
this press release or to reflect the occurrence of unanticipated
events, except as required by law.
Genprex, Inc.
(877) 774-GNPX (4679)
GNPX Investor
Relations
investors@genprex.com
GNPX Media Contact
Kalyn
Dabbs
media@genprex.com
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SOURCE Genprex, Inc.
