Results from Phase 1 Portion Indicate
Favorable Safety Profile of Novel Gene Therapy in Solid Tumor
Cancer
AUSTIN,
Texas, May 30, 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 it has
completed the Phase 1 portion of the Acclaim-1 Phase 1/2 clinical
trial of REQORSA® in combination with Tagrisso® (osimertinib) to
treat late-stage non-small cell lung cancer (NSCLC), and the Safety
Review Committee (SRC) has approved continuation to the Phase 2
expansion portion of the trial. The combination of REQORSA and
osimertinib received U.S. Food and Drug Administration's (FDA) Fast
Track Designation for treatment of the Acclaim-1 patient
population.
Based on full safety data which showed no dose limiting
toxicities, the SRC determined that the recommended Phase 2 dose of
REQORSA will be 0.12 mg/kg. This was the highest dose level
delivered in the Phase 1 portion and is twice the highest dose
level delivered in Genprex's prior clinical trial combining REQORSA
with Tarceva® for the treatment of late-stage lung cancer. The SRC
also recommended the trial advance to the Phase 2 expansion portion
of the study, which the Company expects to begin in the third
quarter of 2023.
"We are proud of the notable progress we made during the Phase 1
portion of the Acclaim-1 clinical trial, and the SRC recommendation
to move into the Phase 2 expansion portion of the trial is another
validation for our REQORSA development program," said Rodney Varner, Chairman, President and Chief
Executive Officer of Genprex. "As we move into the Phase 2
expansion portion of the trial, we remain steadfast in our efforts
to bring new therapies to lung cancer patients with unmet medical
need."
Genprex recently announced positive preliminary clinical data
from the Phase 1 dose escalation portion of its Acclaim-1 clinical
trial in an abstract published at the 2023 American Society of
Clinical Oncology (ASCO) Annual Meeting. The results showed that
REQORSA was generally well tolerated, and there were no dose
limiting toxicities. Genprex also reported that encouraging
evidence of efficacy was observed in the Phase 1 portion of the
study. The full abstract can be accessed here.
The SRC is comprised of three physicians who are principal
investigators in the trial. The SRC may recommend that the trial
continues at the same dose or at a lower dose, that it escalates to
a higher dose, or that the study be terminated altogether due to
safety concerns.
The Phase 2 expansion portion of the study is expected to enroll
approximately 66 patients; half will be patients who received only
prior Tagrisso treatment and the other half will be patients who
received prior Tagrisso treatment and chemotherapy, in order to
determine toxicity profiles of patients with different eligibility
criteria, as well as efficacy and other endpoints. There will be an
interim analysis following the treatment of 19 patients in each
cohort.
About Acclaim-1
The Acclaim-1 clinical trial is an
open-label, multi-center Phase 1/2 clinical trial evaluating the
Company's lead drug candidate, REQORSA, in combination with
Tagrisso in patients with late-stage NSCLC with activating
epidermal growth factor receptor ("EGFR") mutations whose disease
progressed after treatment with Tagrisso.
The enrollment of the dose escalation Phase 1 portion of the
Acclaim-1 trial has been completed. The Phase 2 expansion portion
of the study is expected to enroll approximately 66 patients, half
of whom will have received only Tagrisso treatment and the other
half will have received Tagrisso treatment and chemotherapy, to
determine toxicity profiles of patients with different eligibility
criteria, as well as efficacy and other endpoints. There will be an
interim analysis following the treatment of 19 patients in each
cohort. The Phase 2 randomized portion of the study is expected to
enroll approximately 74 patients to be randomized 1:1 to receive
either REQORSA and Tagrisso combination therapy or platinum-based
chemotherapy. The primary endpoint of the Phase 2 portion of the
trial is progression-free survival, which is defined as time from
randomization to progression or death. An interim analysis will be
performed at 28 events.
About REQORSA® Immunogene Therapy
REQORSA Immunogene
Therapy (quaratusugene ozeplasmid) for non-small cell lung cancer
(NSCLC) uses Genprex's unique, proprietary ONCOPREX® Nanoparticle
Delivery System, which is the first systemic gene therapy delivery
platform used for cancer in human clinical trials. The active agent
in REQORSA is a plasmid that expresses the TUSC2 tumor suppressor
gene. REQORSA consists of the TUSC2 gene expressing plasmid
encapsulated in non-viral lipid nanoparticles made from lipid
molecules with a positive electrical charge. REQORSA is injected
intravenously and specifically targets cancer cells. Once REQORSA
is taken up into a cancer cell, the TUSC2 gene is expressed, and
the TUSC2 protein is capable of restoring certain defective
functions arising in the cancer cell. 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.
Tagrisso® is a registered trademark of AstraZeneca plc and is
its top-selling drug with 2022 sales of more than $5 billion.
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). Both NSCLC clinical programs 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
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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.