Reqorsa® Therapy May Be
Potential Treatment for ALK-Positive Lung Cancer
Three Collaborators Selected to Present
Positive Nonclinical Data on Genprex Oncology Program at the 2024
American Association for Cancer Research (AACR) Annual
Meeting
AUSTIN,
Texas, Feb. 7, 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 expansion of its nonclinical programs into new
indications through Sponsored Research Agreements and Material
Transfer Agreements with multiple academic research collaborators
to study TUSC2, the tumor suppressor gene used in Genprex's lead
drug candidate, REQORSA (quaratusugene ozeplasmid), and NPRL2,
another tumor suppressor gene. The new indications being evaluated
include ALK-positive lung cancer and other additional programs that
are not disclosed at this time.
"We are developing a robust research program to
expand the potential tumor targets, and even non-tumor targets,
that we may include in future clinical trials for REQORSA," said
Rodney Varner, Chairman, President
and Chief Executive Officer at Genprex. "Research indicates that
the TUSC2 gene used in REQORSA may benefit many types of cancers
and potentially the treatment of other diseases. We are exploring
opportunities to treat other cancers in which TUSC2 is often
deleted or inactivated, and we are evaluating TUSC2 basic biology
to better understand how to use our REQORSA treatment. Finally, we
are also exploring the use of another tumor suppressor gene, NPRL2,
in cancer treatment using our Oncoprex® Nanoparticle
Delivery System."
Genprex's expanded nonclinical programs include
these additional studies with TUSC2 and NPRL2:
- TUSC2 in ALK-EML4 positive translocated lung cancer at the
University of Michigan Rogel Cancer
Center
- TUSC2 in metabolism at Meharry Medical College in
Nashville, Tennessee
- NPRL2 in lung cancers with a major cancer research center in
Houston, Texas
TUSC2 in ALK-EML4 positive translocated lung
cancer at the University of Michigan
Rogel Cancer Center's Judith Tam ALK Lung Cancer Research
Initiative:
ALK-EML4 positive translocated lung cancer is a
subset of non-small cell lung cancer (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 we believe leaves
substantial room for improvement.
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 Rogel Cancer Center's
Judith Tam ALK Lung Cancer Research Initiative are studying the
combination of Genprex's REQORSA, which uses the TUSC2 tumor
suppressor gene, with various ALK inhibitors. An abstract submitted
by these researchers was accepted for presentation at the 2024 AACR
Annual Meeting.
TUSC2 Control of Mitochondrial Metabolism at
Meharry Medical College:
The TUSC2 gene is encoded in the cell's DNA in
the nucleus, but the TUSC2 protein resides in the inner membrane of
the mitochondria. This suggests that TUSC2 protein may be one way
in which the cell controls energy production, which largely occurs
in the inner membrane of the mitochondria. In addition, mice
lacking the TUSC2 gene in all cells, or TUSC2 knock-out mice, can
exhibit a number of characteristics consistent with underlying
metabolic abnormalities, including premature aging,
aging-associated pathologies, and decreased survival. Thus,
researchers at Meharry Medical College have been exploring
TUSC2 effects on mitochondrial metabolism and have had their work
accepted for presentation at the 2024 AACR Annual Meeting.
NPRL2 in Lung Cancers
Following a presentation on NPRL2 at AACR 2023,
additional research has been performed to evaluate the use of lipid
nanoparticles containing the tumor suppressor gene, NPRL2, in mouse
xenografts with resistant cancers. This work, which validates
Genprex's ONCOPREX Nanoparticle Delivery System technology as a
platform, has been selected for a presentation at the 2024 AACR
Annual Meeting.
Genprex's ONCOPREX® Nanoparticle
Delivery System, is a novel non-viral approach that utilizes lipid
nanoparticles to deliver tumor suppressor genes deleted during the
course of cancer development. The platform allows for the
intravenous delivery of various tumor suppressor genes, and
potentially other genes, to achieve a therapeutic affect without
the risk of toxicity often associated with viral delivery systems.
Genprex believes this system allows for delivery of a number of
cancer-fighting genes, alone or in combination with other cancer
therapies, to combat multiple types of cancer.
About Reqorsa®
Therapy
REQORSA® (quaratusugene ozeplasmid) for
NSCLC and SCLC consists of the TUSC2 gene expressing plasmid
encapsulated in non-viral nanoparticles made from lipid molecules
(Genprex's ONCOPREX® Nanoparticle 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®
Nanoparticle Delivery System which encapsulates the gene-expressing
plasmids using lipid nanoparticles. 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® Immunogene Therapy (quaratusugene ozeplasmid),
is being evaluated in three clinical trials as a treatment for
NSCLC and SCLC. Each of Genprex's three 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-003 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, 2022.
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:
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; 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.