Compelling Data Validates the Potential of
Reqorsa® Immunogene Therapy and the Oncoprex® Delivery System as
Innovative Cancer Treatments
REQORSA Has Anti-Tumor Mechanisms and Ability
to Trigger Cancer Cell Death
AUSTIN,
Texas, April 9, 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 that its research collaborators presented positive
preclinical data for Reqorsa® Immunogene Therapy (quaratusugene
ozeplasmid) and NPRL2 gene therapy, which both utilize the
Company's non-viral Oncoprex® Delivery System for the treatment of
lung cancer. These studies were presented at the 2024 American
Association for Cancer Research (AACR) Annual Meeting, which is
being held April 5-10, 2024 in
San Diego, California.
"We continue to expand our growing body of preclinical evidence
supporting REQORSA's therapeutic potential to treat a variety of
cancers, as well as the therapeutic potential of our non-viral
delivery system to deliver tumor suppressor genes for the treatment
of cancer," said Rodney Varner,
Chairman, President and Chief Executive Officer at Genprex. "We are
especially delighted to have three preclinical studies presented at
one of the largest professional cancer research meetings among the
world's top oncologists and the cancer research community."
Featured Genprex-supported posters presented at AACR 2024
include:
Title: "Quaratusugene ozeplasmid mediated TUSC2
upregulation in EML4-ALK bearing Non-Small Cell Lung Carcinoma can
induce cellular apoptosis"
Session Category: Molecular/Cellular Biology and
Genetics
Session Title: Apoptosis and Ferroptosis
Session Date and Time: Sunday, April 7 from
1:30 p.m. – 5:00 p.m. PT
Location: Poster Section 15
Poster Board Number: 7
Abstract Presentation Number: 351
Title: "Mechanism of NPRL2 gene therapy induced
anti-tumor immunity in KRAS/STK11mt aPD1 resistant
metastatic NSCLC"
Session Category: Immunology
Session Title: Inflammation, Host Factors, and
Epigenetic Influences on Cancer Development and Treatment
Session Date and Time: Monday, April 8 from
9:00 a.m. – 12:30 p.m. PT
Location: Poster Section 5
Poster Board Number: 18
Abstract Presentation Number: 1420
Title: "Tumor Suppressor Gene TUSC2 suppresses energy
metabolism in lung cancer cells with opposite effects in normal
bronchial epithelial cells"
Session Category: Experimental and Molecular
Therapeutics
Session Title: Cancer Biology and Metastasis
Session Date and Time: Monday, April
8 from 1:30 p.m. –
5:00 p.m. PT
Location: Poster Section 22
Poster Board Number: 6
Abstract Presentation Number: 3158
In the first poster, entitled "Quaratusugene ozeplasmid mediated
TUSC2 upregulation in EML4-ALK bearing Non-Small Cell Lung
Carcinoma can induce cellular apoptosis," researchers reported that
REQORSA induced apoptosis in alectinib resistant EML4-ALK positive
non-small cell lung cancer (NSCLC) cell lines. Alectinib is an
ALK-inhibitor commonly used to treat patients with ALK
rearrangements such as EML4-ALK positive NSCLCs. This research
suggests that REQORSA may be an effective treatment in patients
progressing on alectinib.
The second poster, entitled, "Mechanism of NPRL2 gene therapy
induced anti-tumor immunity in KRAS/STK11mt aPD1
resistant metastatic NSCLC" detailed a humanized mouse model study
in which the researchers investigated the anti-tumor immune
responses to NPRL2 gene therapy in pembrolizumab resistant
KRAS/STK11mt NSCLC. In the study, lung metastases in
humanized mice were treated through I.V. injection of NPRL2
nanoparticles, made with the ONCOPREX Delivery System, with or
without pembrolizumab. The study found that the NPRL2 treatment by
itself led to a marked decrease in the size of lung metastases but
pembrolizumab had no effect. Additionally, a greater anti-tumor
effect was seen in humanized compared to non-humanized mice,
demonstrating that immune cells play a role in the effects of the
NPRL2 nanoparticle therapy. Study findings suggest that NPRL2 gene
therapy induces anti-tumor activity against KRAS/STK11mt
tumors through dendritic cell-mediated antigen presentation and
cytotoxic immune cell activation. The Company believes this data
could support the potential for a new drug candidate in its
pipeline, and it also provides further evidence for the Company's
belief that the ONCOPREX Delivery System has the ability to be
successful using genes other than the TUSC2 gene the Company is
already using in clinical trials with REQORSA.
In the third poster, entitled, "Tumor Suppressor Gene TUSC2
suppresses energy metabolism in lung cancer cells with opposite
effects in normal bronchial epithelial cells" researchers reported
that TUSC2-deficient cancer cells consistently exhibited decreased
glycolytic rates and mitochondrial ATP production, leaving these
cells without enough energy to support their vital functions. By
comparison, when Beas2B, a normal human bronchial epithelial cell
line with normal levels of TUSC2, was transfected with a TUSC2
containing plasmid, the glycolytic rate and mitochondrial
metabolism was increased. This suggests the mechanism by which
REQORSA treatment affects immune and other non-cancerous cells that
leads to increased immune response against tumors. The study
further suggested that REQORSA may play an important role as a
cancer treatment to target and disrupt the metabolism of cancer
cells, leading to a decrease in the rate of glycolysis.
These AACR posters have been made available on Genprex's website
at www.genprex.com.
About Reqorsa® 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 The Oncoprex® Delivery System
Genprex's ONCOPREX
Delivery System is a novel non-viral approach that utilizes
lipid-based nanoparticles in a lipoplex form 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 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®
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-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
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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:
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.