Provides Additional Protection in Large
Markets for Therapeutic Combination in Acclaim-2 Phase 1/2 Clinical
Trial
Patent Already Granted for Same
Combination in U.S. Japan,
Australia, Russia and Mexico
AUSTIN,
Texas, July 5, 2023 /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 China
National Intellectual Property Administration has granted Genprex
China Patent No: 201780076886.X. The broad patent covers the use of
Genprex's lead drug candidate, REQORSA® Immunogene
Therapy, in combination with PD1 antibodies through 2037.
"This is a very important patent because it provides Genprex
with additional protection for our REQORSA gene therapy in
combination with PD1 antibodies, such as Keyruda®, which
is the subject of our ongoing Acclaim-2 clinical trial for the
treatment of lung cancer," said Thomas
Gallagher, Esq., Senior Vice President of Intellectual
Property and Licensing at Genprex. "Genprex has already received
this patent protection in the U.S., Japan, Australia, Russia and Mexico. Now with the same patent protection in
China, we have secured exclusivity
for this drug combination for the treatment of cancer in many of
the largest markets. This patent protection prevents others from
making, using or selling this drug combination."
Acclaim-2 is an open-label, dose escalation and clinical
response study of REQORSA in combination with Keytruda in patients
with advanced, metastatic non-small cell lung cancer (NSCLC) whose
disease progressed after treatment with Keytruda. More information
on Acclaim-2 can be found
at www.clinicaltrials.gov Identifier NCT05062980.
In 2022, Genprex received a U.S. patent granting protection for
the combination of REQORSA with PD1 antibodies for the treatment of
cancer. In 2021, Genprex received U.S. Food and Drug
Administration's (FDA) Fast Track Designation for treatment of the
Acclaim-2 patient population.
About Acclaim-2
The Acclaim-2 trial is a Phase 1/2
open-label, dose-escalation and clinical response study of REQORSA
in combination with Keytruda in patients with advanced, metastatic
non-small-cell lung cancer who have progressed after treatment with
Keytruda. The Company anticipates enrolling patients at
approximately 10 clinical sites and estimates that the Phase 1 dose
escalation portion of the Acclaim-2 trial will enroll up to 18
patients, the Phase 2 expansion portion will enroll approximately
36 patients, and the Phase 2 randomized portion will enroll
approximately 126 patients. Patients enrolled in the Phase 2
randomized portion of the study will be randomized 2:1 to either
REQORSA and Keytruda combination therapy or to chemotherapy
(docetaxel with or without ramucirumab). Patients will be treated
until disease progression or unacceptable toxicity is
experienced. Patients must have histologically confirmed
unresectable stage III or IV NSCLC (any histology) with
radiological progression on Keytruda and an ECOG performance status
of 0 to 1. Genprex expects to complete enrollment for the Phase 1
dose escalation portion of Acclaim-2 by the first quarter of
2024.
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 proprietary, 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®
(quaratusugene ozeplasmid), is being evaluated in three clinical
trials as a treatment for non-small cell lung cancer (NSCLC) and
small cell lung cancer (SCLC). Each of Genprex's three lung cancer
clinical programs have received a Fast Track Designation from the
Food and Drug Administration. Genprex's diabetes gene therapy
approach is comprised of a novel infusion process that uses an
adeno-associated virus (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 are 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; 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 continue 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.