Research to Study TUSC2 Combined with
ALK-Inhibitors
Collaboration with Non-Profit Patient-Focused
Research Group Expands Potential Lung Cancer Patient Population
for Reqorsa® Gene Therapy
AUSTIN, Texas , Oct. 24,
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 Company has entered into a
Sponsored Research Agreement (SRA) with the University of Michigan Rogel Cancer Center to study
TUSC2, the tumor suppressor gene used in Genprex's lead drug
candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), in
combination with ALK-inhibitors in ALK-EML4 positive translocated
lung cancer.
The Company also announced its collaboration with ALK Positive,
a non-profit patient-driven research organization dedicated to
improving the life expectancy and quality of life for ALK-positive
(ALK+) lung cancer patients. As a part of this collaboration, both
Genprex and ALK Positive will share the cost of the SRA with the
University of Michigan Rogel Cancer
Center.
"We are excited to collaborate with the University of Michigan Rogel Cancer Center and ALK
Positive, a group that is dedicated to helping patients with this
specific subset of lung cancer, to further study how REQORSA in
combination with ALK-inhibitors may be a potential therapeutic
treatment for ALK+ lung cancer," said Ryan
Confer, President and Chief Executive Officer
at Genprex. "TUSC2 is often deleted or inactivated in certain
types of cancer. Our preclinical data in cell lines with ALK
translocations indicate that REQORSA may be effective in
combination with ALK inhibitors, and the work in this SRA will
build on our earlier studies."
As the Company further expands its research program to new tumor
targets, REQORSA in combination with ALK-inhibitors could be a
potential therapeutic treatment for ALK+ lung cancer. TUSC2 is a
tumor suppressor gene that is frequently deleted in lung cancer. In
fact, approximately 82% of all non-small cell lung cancers (NSCLCs)
have decreased amounts of the TUSC2 tumor suppressor protein. ALK
translocations are found in approximately 5% of NSCLCs.
Research collaborators at the Rogel Cancer Center's Judith Tam
ALK Lung Cancer Research Initiative presented positive preclinical
data at the April 2024 American
Association for Cancer Research (AACR) Annual Meeting, reporting
that REQORSA induced apoptosis in alectinib resistant EML4-ALK
positive NSCLC cell lines. Alectinib is an ALK-inhibitor commonly
used to treat patients with ALK rearrangements such as EML4-ALK
positive NSCLCs. Researchers found that overexpressing TUSC2 using
REQORSA treatment in ALK+ lung cancer cell lines inhibited the
ability of the cells to form colonies. Ultimately, the study found
that the use of REQORSA or a TUSC2-containing plasmid to
overexpress TUSC2 in ALK+ NSCLC cell lines was effective in
decreasing cell growth and proliferation through the activation of
apoptotic pathways. Researchers believe the results of this
preclinical work support further clinical study of REQORSA as an
anti-ALK NSCLC treatment strategy. Genprex believes this research
suggests that REQORSA may be an effective treatment in patients
progressing on alectinib. To review the poster presented at the
April 2024 AACR Annual meeting, visit
Genprex's website.
ALK+ lung cancer is a subset of NSCLC that impacts young and
relatively healthy individuals. Since the discovery of the ALK-EML4
translocation, there has been research into targeting and treating
this malignancy, which has led to approval by the U.S. Food and
Drug Administration (FDA) of various ALK-targeted therapies
including crizotinib, alectinib and lorlatinib. Although these
compounds provide significant benefit in treating ALK-EML4-driven
malignancies initially, resistance ultimately develops. The 5-year
survival rate of ALK-EML4 translocated lung cancers is 40.9%, which
is higher than other types of lung cancer, but the Company believes
this percentage leaves substantial room for improvement.
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, such as the ALK
pathway, re-establishes pathways for programmed cell death, or
apoptosis, in cancer cells, decreases cancer cell energy production
by decreasing glycolysis, 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 combination with
ALK-inhibitors for ALK-positive lung cancer; 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.
