Multiple clinical trial sites to be
opened under collaboration with large network of community-based
oncology
practices
Acclaim-3 Study Supported by FDA Orphan Drug
and Fast Track Designations
AUSTIN, Texas, April 3, 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 through its
collaboration agreement with a large network of integrated,
community-based oncology practices, the Company has added multiple
clinical trial sites for its Acclaim-3 clinical study of
Reqorsa® Immunogene Therapy (quaratusugene ozeplasmid)
in combination with Genentech's Tecentriq®
(atezolizumab) to treat patients with extensive-stage small cell
lung cancer (ES-SCLC).
"With the majority of oncology patients treated by
community-based oncology practices, this collaboration to expand
our Acclaim-3 clinical study to additional trial sites is important
as it may accelerate patient enrollment, provide access to our
innovative clinical trial treatment for patients outside of major
urban or academic settings, broaden the geographic reach of our
study to more ES-SCLC patients in need and potentially benefit
ES-SCLC patients who currently have limited benefit from existing
treatment options," said Rodney
Varner, President, Chairman and Chief Executive Officer at
Genprex. "This collaboration leverages the broad network of
oncologists and enables patients to access our promising treatment
at the office of their primary oncologist, while allowing Genprex
to more efficiently and expeditiously accelerate our Acclaim-3
clinical trial."
ES-SCLC is an aggressive form of lung cancer that is presently
incurable. ES-SCLC has a median progression free survival (PFS) of
5.4 months from the start of initial therapy. However, once
patients start receiving maintenance therapy with Tecentriq they
have a median PFS of only 2.6 months. The combination of REQORSA
and Tecentriq as maintenance therapy may provide a new therapeutic
option for the treatment of small cell lung cancer (SCLC).
Genprex has a novel cancer treatment platform that re-expresses
tumor suppressor genes in cancers. Tumor suppressor genes are often
deleted or inactivated early in the process of cancer development.
REQORSA, the Company's lead drug candidate, contains a plasmid that
expresses TUSC2, a tumor suppressor gene protein. Nearly 100% of
SCLCs have reduced or no TUSC2 protein expression, and 41% of SCLCs
completely lack TUSC2 protein expression. Preclinical studies in
mice support the hypothesis that re-expressing the TUSC2 protein
may lead to improved clinical efficacy in combination with
Tecentriq.
"We look forward to continuing our relationship with this large,
nationwide network of oncology practices for our Acclaim-3 clinical
trial in SCLC, which is the same partner we used for our Acclaim-1
clinical trial in NSCLC," said Mark
Berger, M.D., Chief Medical Officer at Genprex. "Based on
the success we experienced in patient enrollment from our other
lung cancer clinical trial, we believe this collaboration will
enhance our patient enrollment for Acclaim-3 and help us to
expeditiously begin treating patients in need."
About the Acclaim-3 Clinical Trial
The Acclaim-3
clinical trial is a Phase 1/2 open-label, dose escalation and
clinical response study of maintenance therapy evaluating
Reqorsa® in combination with Tecentriq in patients
with ES-SCLC. The Acclaim-3 clinical trial will enroll
patients who did not develop tumor progression after receiving
Tecentriq and chemotherapy as standard initial treatment, and
who are therefore eligible for maintenance therapy.
The Phase 1 dose escalation portion of the Acclaim-3 clinical
study was initially expected to enroll up to 12 patients at three
to five U.S. clinical sites, which has now doubled to approximately
10 U.S. clinical sites, to determine the Maximum Tolerated Dose
(MTD). If no dose limiting toxicities occur during the Phase 1
study, the highest dose evaluated will be the Recommended Phase 2
Dose. The Phase 2 portion of the study is expected to enroll
approximately 50 patients at ten to fifteen U.S. sites. Patients
will be treated with REQORSA and Tecentriq until disease
progression or unacceptable toxicity is experienced. Genprex
expects to initiate the Phase 2 expansion study in the second half
of 2024.
The primary endpoint of the Phase 2 portion of the trial is to
determine the 18-week progression-free survival rate from the time
of the start of maintenance therapy with REQORSA and Tecentriq
treatment in patients with ES-SCLC. Patients will also be followed
for survival. A Phase 2 futility analysis will be performed after
the 25th patient enrolled and treated
reaches 18 weeks of follow up.
Genprex has received U.S. Food and Drug Administration (FDA)
Ophran Drug and Fast Track designations for the Acclaim-3 patient
population. Additional information about the Acclaim-3 clinical
trial can be found by visiting ClinicalTrials.gov.
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
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.