NPRL2 Gene Therapy Induces Anti-Tumor Activity
in Anti-PD1 Resistant KRAS/STK11 Mutant Non-Small Cell Lung Cancer
in a Humanized Mouse Model
Provides Additional Preclinical Validation of
Oncoprex® Delivery System With Another Tumor Suppressor
Gene
AUSTIN,
Texas, April 2, 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 have published positive preclinical data for
the NPRL2 tumor suppressor gene, utilizing the Company's non-viral
Oncoprex® Delivery System, in KRAS/STK11 mutant anti-PD1 resistant
non-small cell lung cancer (NSCLC) in a humanized mouse model.
NPRL2 is a tumor suppressor gene whose expression is reduced in
many cancers including lung, renal, colorectal, glioma, gastric,
and hepatocellular carcinoma, and it has been closely correlated
with poor clinical outcomes.
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.
The manuscript, titled, "NPRL2 gene therapy induces effective
anti-tumor immunity in KRAS/STK11 mutant anti-PD1 resistant
metastatic non-small cell lung cancer (NSCLC) in a humanized mouse
model," was published on the bioRxiv biology preprint server.
"These positive preclinical data are very encouraging and
support NPRL2 gene therapy as a potential treatment for a sub-group
of NSCLC in which patients traditionally are resistant to existing
therapies," said Rodney Varner,
President, Chairman and Chief Executive Officer at Genprex. "We
believe this data could support the potential for a new drug
candidate in our pipeline, and it also provides further evidence
that the Oncoprex® Delivery System has the ability to be successful
using genes other than the TUSC2 gene we are already using in
clinical trials with Reqorsa®."
The studies evaluated the intravenous injection of NPRL2
gene-loaded cationic lipoplexes (DOTAP-NPRL2) with or without
anti-PD1 drugs (pembrolizumab). The studies used a KRAS/STK11
mutant anti-PD1 insensitive cell line, as well as syngeneic mouse
LLC2 tumors, which are also anti-PD1 resistant. In both of these
mouse models, NPRL2 showed a significantly strong anti-tumor effect
whereas anti-PD1 (pembrolizumab) was not effective. The anti-tumor
effect was greater in humanized mice than non-humanized mice,
suggesting that an immune response contributed to anti-tumor
activity.
Additionally, a dramatic anti-tumor effect was mediated by NPRL2
treatment with or without a pembrolizumab combination.
Bioluminescence imaging on mice showed that 7 out of 10 mice
contained an extremely low amount of tumor burden in the NPRL2
treatment group, which was significantly different than in the
control or pembrolizumab group.
Unlike previous experiments with Reqorsa® Immunogene Therapy
(quartusugene ozeplasmid), the Company's lead drug candidate using
the TUSC2 tumor suppressor gene, the anti-tumor efficacy of
DOTAP-NPRL2 did not involve Natural Killer (NK) cells. The studies
also found that tumors with stable NPRL2 expression exhibited
significantly slower growth compared to controls. In conclusion,
researchers reported that NPRL2 gene therapy induces anti-tumor
activity through dendritic cell-mediated antigen presentation and
cytotoxic immune cell activation.
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
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Genprex's ability to advance the clinical development,
manufacturing and commercialization of its product candidates in
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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
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perform and scale up the manufacture of its product candidates; and
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events or circumstances discussed or reflected in these statements
will be achieved or will occur. If such forward-looking statements
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Genprex or any other person that Genprex will achieve its
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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)
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