Reqorsa® Gene Therapy Overcomes Acquired
Resistance to Lumakras® in Lung Cancer
REQORSA Demonstrated Potent Tumor Suppressive
Activity in Mesothelioma
REQORSA Induces Apoptosis in
Glioblastoma
AUSTIN,
Texas, Oct. 10, 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 will present at the upcoming 2024
EORTC-NCI-AACR Symposium on Molecular Targets and Cancer
Therapeutics being held October 23-25,
2024 in Barcelona, Spain.
The collaborators will present posters on positive preclinical data
from studies of its lead drug candidate, Reqorsa® Gene Therapy
(quaratusugene ozeplasmid), for the treatment of Ras inhibitor
resistant lung cancer, mesothelioma and glioblastoma.
"The compelling data made available today validates the
potential of REQORSA as a therapeutic treatment for some of the
most difficult to treat cancers and diseases, including Ras
inhibitor resistant lung cancer, mesothelioma and glioblastoma,"
said Ryan Confer, President and
Chief Executive Officer at Genprex. "We are very encouraged to see
the data support potential new indications for REQORSA, which could
address unmet medical need for many patient populations. We look
forward to continuing our preclinical programs studying REQORSA to
explore how we could expand our clinical development pipeline with
future clinical studies."
Genprex has filed two provisional patent applications based on
data from two of the presentations. One application involves using
REQORSA to treat mesothelioma and the other uses REQORSA to treat
glioblastoma. Genprex is a co-owner of the applications along with
the respective institutions. TUSC2 is the tumor suppressor gene
used in REQORSA.
Featured Genprex-supported posters to be presented at the 2024
EORTC-NCI-AACR Symposium on Molecular Targets and Cancer
Therapeutics include:
Title: "TUSC2 Gene Therapy in KRASG12C
Mutant NSCLC Overcomes Acquired Resistance to Sotorasib"
Collaborator: The University of
Texas MD Anderson Cancer Center
Catalog Number: 384
Presentation Number: PB372
Acquired resistance (AR) to Lumakras® (sotorasib), the first
FDA-approved KRASi, poses a significant challenge in the treatment
of KRASG12C mutant non-small cell lung cancer (NSCLC).
Despite an initial response rate of up to 40%, patients invariably
develop resistance, necessitating alternative therapeutic
strategies. The mechanisms of AR include the emergence of
additional mutations in the KRAS gene, reactivation of KRAS
pathway, or activation of alternative signaling pathways. TUSC2, a
potent tumor suppressor gene, exhibits multifunctional activities
including multikinase inhibition, inhibition of growth &
proliferation, induction of cell death and activation of both
innate and adaptive immune responses. In this study, researchers
demonstrated that TUSC2 gene therapy (REQORSA) effectively
overcomes sotorasib AR in KRASG12Cmutant NSCLC mouse
xenografts.
The data indicates that TUSC2 transfection significantly reduced
colony formation in two AR cell lines. Transfection of TUSC2 also
markedly increased apoptosis in AR cells. H23AR xenograft tumors
exhibited significantly lower sensitivity to sotorasib than their
parental counterparts. However, treatment with REQORSA alone or in
combination with sotorasib was highly effective in controlling
H23AR tumor growth in mouse xenografts. REQORSA alone also
exhibited significantly strong antitumor effect on TC314AR
patient-derived xenografts (PDXs) where sotorasib alone showed no
significant antitumor activity. However, a synergistic antitumor
effect was observed when TC314AR PDX tumors were treated with the
combination of REQORSA and sotorasib.
In conclusion, researchers demonstrated that TUSC2 therapy,
alone or in combination with sotorasib inhibited colony formation,
induced apoptosis, and showed significant antitumor efficacy in
KRASG12C mutant acquired resistant xenografts and in PDX
tumor xenografts.
Title: "TUSC2 Suppresses Tumorigenic Properties in
Malignant Pleural Mesothelioma Cells"
Collaborator: New York
University Langone Health
Catalog Number: 364
Presentation Number: PB352
Malignant Pleural Mesothelioma (MPM) is a rare, highly
aggressive, asbestos-associated neoplasm with a median survival of
10-12 months. TUSC2 is frequently deleted in multiple cancers and
at least one allele is absent in 36% of MPM. Researchers
investigated whether TUSC2 transfection could modulate MPM
aggressive properties.
In this study, four MPM cell lines and tert-transformed
mesothelial LP9 cells were treated with REQORSA and control
liposomes for 48h. Treated cells were then evaluated for TUSC2
expression by semi quantitative RT-PCR, Western blot analysis, and
functional assays including cell proliferation, invasion, and
apoptosis.
The researchers demonstrated that REQORSA treatment resulted in
a significant decrease in cell proliferation, cell invasion, and a
significant increase in cell apoptosis in all four MPM cell lines.
Data also demonstrated potent tumor suppressive activity of the
TUSC2 gene delivered by REQORSA, and thus, its re-expression could
serve as a potential therapeutic strategy for the treatment of
MPM.
Title: "Efficacy of Quaratusugene Ozeplasmid (REQORSA)
TUSC2 Gene Therapy in Glioblastoma"
Collaborator: The University of Texas
Health Science Center at Houston
Catalog Number: 130
Presentation Number: PB118
Research collaborators previously reported TUSC2 as a novel
tumor suppressor for glioblastoma, the most common and deadliest
primary brain tumor in adults which is associated with a poor
prognosis. In their latest study, patient-derived glioblastoma
(GBM) cell lines and patient-derived glioma stem cell (PD-GSC)
lines were used. REQORSA was used to restore TUSC2 expression.
Researchers observed that REQORSA significantly reduced GBM cell
viability, and the results of a migration assay demonstrated that
REQORSA suppressed GBM cell migration independent of its ability to
suppress cell viability. In conclusion, REQORSA demonstrates
promising in vitro efficacy in GBM and PD-GSCs, and these
results support further evaluation of its in vivo anti-tumor
efficacy in malignant gliomas using mouse models.
About Reqorsa® Gene Therapy
REQORSA (quaratusugene
ozeplasmid) consists of a plasmid containing the TUSC2 gene
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.
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 inhibitor
resistant lung cancer, mesothelioma and glioblastoma; 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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