License includes Genprex's Reqorsa®
Gene Therapy in Combination with ALK-Inhibitors for
the Potential Treatment of ALK-Positive Lung
Cancer
AUSTIN,
Texas, Nov. 20, 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 it has entered into an exclusive license agreement
with the University of Michigan,
granting Genprex a worldwide, exclusive license to the University's
patent rights relating toits lead drug candidate,
Reqorsa® Gene Therapy (quaratusugene ozeplasmid), in
combination with ALK-inhibitors for the potential treatment of
ALK-EML4 positive translocated lung cancer.
"We continue to bolster our intellectual property portfolio for
REQORSA, understanding that our lead drug candidate may benefit
patients with many types of cancers," said Thomas Gallagher, Esq., Senior Vice President of
Intellectual Property and Licensing at Genprex. "Positive
preclinical data indicate that REQORSA in combination with ALK
inhibitors may provide benefit to patients with ALK-positive (ALK+)
lung cancer. We are pleased to be able to protect this drug
combination for a new subset of lung cancer patients, which widens
our exclusivity of drug combinations with REQORSA and enhances our
intellectual property position."
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 NSCLCs lack or express decreased amounts
of TUSC2 tumor suppressor protein. ALK translocations are found in
approximately 5% of NSCLCs. Research collaborators at the
University of Michigan 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 non-small cell lung cancer (NSCLC) cell
lines.
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 ALK inhibitors. To review the poster presented at
the 2024 AACR Annual meeting, visit Genprex's website.
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 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.