Expands on the previously granted patents
covering the use of REQORSA in combination with immune checkpoint
inhibitors applicable to Genprex's Acclaim-2 and Acclaim-3 clinical
trials
AUSTIN,
Texas, March 12, 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 the Korean Patent Office has issued a Notice
of Patent Grant for a broad patent that covers the use of Genprex's
lead drug candidate, Reqorsa® Immunogene Therapy, in combination
with anti-PD-1 and PD-L1 antibodies through 2037.
This patent will expand on the previously granted patents in the
U.S., Japan, Mexico, Russia, Australia, Chile and China to cover the use of REQORSA in
combination with immune checkpoint inhibitors, e.g., PD-1 and PD-L1
inhibitors. These patents are applicable to Genprex's Acclaim-2 and
Acclaim-3 clinical trials.
"We continue to secure exclusivity for our drug combinations of
REQORSA with PD-1 antibodies, such as Keytruda® and PD-L1
antibodies, such as Tecentriq®, for the treatment of cancer in some
of the largest markets," said Thomas
Gallagher, Esq., Senior Vice President of Intellectual
Property and Licensing at Genprex. "It is important that we
continue to add to our global intellectual property estate and to
build protection around our drug combinations as we advance REQORSA
through the clinic."
The Acclaim-2 study is a Phase 1/2 clinical trial that has three
portions - a Phase 1 dose escalation portion, a Phase 2a expansion
portion, and a Phase 2b randomized
portion. The Acclaim-2 trial uses a combination of REQORSA and
Merck & Co.'s Keytruda® in patients with late-stage non-small
cell lung cancer (NSCLC) whose disease has progressed after
treatment with Keytruda. Patients are treated at the 0.06 mg/kg
dose level in the first cohort of patients and, subject to the
Acclaim-2 SRC approval, will be treated at successive dose levels
of 0.09 mg/kg and 0.12 mg/kg. Genprex expects to complete
enrollment in the Phase 1 dose escalation portion of the Acclaim-2
study in the second half of 2024. Genprex was granted FDA Fast
Track Designation for the Acclaim-2 patient population.
The Acclaim-3 study has two portions - a Phase 1 dose escalation
portion and a Phase 2 expansion portion. In November 2022 Genprex filed with the FDA the
protocol for the Phase 1/2 Acclaim-3 clinical trial using a
combination of REQORSA and Genentech's Tecentriq® as maintenance
therapy for patients with extensive stage small cell lung cancer
(ES-SCLC) who develop tumor progression after receiving Tecentriq
and chemotherapy as initial standard treatment. Patients will be
treated with REQORSA and Tecentriq until disease progression or
unacceptable toxicity is experienced. The Phase 1 portion of the
Acclaim-3 study is open for enrollment, and Genprex expects to
complete the Phase 1 portion of the study by the second half of
2024. Genprex was granted FDA Fast Track Designation and Orphan
Drug Designation for the Acclaim-3 patient population.
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
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.