Expects to Complete Enrollment of First 25
Patients in Phase 2 Expansion Study During Second Half of 2025 for
Interim Analysis
Acclaim-3 Study Has FDA Orphan Drug and Fast
Track Designations
AUSTIN,
Texas, Jan. 23, 2025 /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
first patient has been enrolled and dosed in the Phase 2 expansion
portion of the Company's Acclaim-3 clinical study of
Reqorsa® Gene Therapy (quaratusugene ozeplasmid) in
combination with Tecentriq® (atezolizumab) as
maintenance therapy for patients with extensive stage small cell
lung cancer (ES-SCLC).
"We are excited to begin the Phase 2 expansion portion of
Acclaim-3, which will determine the 18-week Progression Free
Survival (PFS) rate of REQORSA and Tecentriq combination
maintenance therapy," said Mark
Berger, MD, Chief Medical Officer at Genprex. "ES-SCLC has a
poor prognosis with a median PFS of 5.2 months. Those patients
receiving Tecentriq as maintenance therapy have a median PFS of 2.6
months after the start of maintenance therapy. We look forward to
studying the combination of REQORSA and Tecentriq as we work to
advance our innovative gene therapy."
The Phase 2 expansion portion will enroll 50 patients at
approximately 10 to 15 U.S. sites. Patients will be treated with
REQORSA and Tecentriq until disease progression or unacceptable
toxicity is experienced. The primary endpoint of the Phase 2
portion is to determine the 18-week progression-free survival rate
from the time of the start of maintenance therapy with REQORSA and
Tecentriq in patients with ES-SCLC. Patients will also be followed
for survival. A Phase 2 interim analysis will be performed after
the 25th patient enrolled and treated reaches 18 weeks of follow
up. The Company expects to complete enrollment of the first 25
patients in the second half of 2025 for interim analysis.
The combination of REQORSA and Tecentriq previously received the
U.S. Food and Drug Administration's (FDA) Fast Track Designation
for the treatment of the Acclaim-3 patient population, and the FDA
has also granted Orphan Drug Designation to REQORSA for the
treatment of 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 contains a plasmid that expresses TUSC2, a tumor suppressor
gene protein. Nearly 100% of SCLCs have reduced or no TUSC2 protein
expression, and 41% completely lack TUSC2 protein expression.
Nonclinical studies in mice support the hypothesis that
re-expressing the TUSC2 protein may lead to improved clinical
efficacy in combination with Tecentriq.
Data presented at the October 2023
AACR-NCI-EORTC International Conference on Molecular Targets and
Cancer Therapeutics from studies in humanized mouse models of SCLC
that use human H841 SCLC cells have shown that the combination of
REQORSA and Tecentriq provides significantly better control of
tumor burden than either agent alone. The data from these
studies also suggest that a combination treatment of REQORSA and
Tecentriq can promote a significantly increased tumor cell killing
effect in SCLC xenografts compared to that of Tecentriq alone.
About Acclaim-3
The Acclaim-3 clinical trial is an
open-label, multi-center Phase 1/2 clinical trial evaluating the
Company's lead drug candidate, Reqorsa® Gene Therapy, in
combination with Genentech, Inc.'s Tecentriq®
(atezolizumab) as maintenance therapy in patients with extensive
stage small cell lung cancer (ES-SCLC) who did not develop tumor
progression after receiving Tecentriq and chemotherapy as initial
standard treatment.
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® Gene Therapy (quaratusugene ozeplasmid), is
being evaluated in two clinical trials as a treatment for NSCLC and
SCLC. Each of Genprex's 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
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, 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, such as
REQORSA in combination with other therapies in SCLC; the timing and
success of Genprex's clinical trials and regulatory approvals,
including, but not limited to, the enrollment of the Phase 2
expansion portions of the Acclaim-3 trial; the effect of Genprex's
product candidates, alone and in combination with other therapies,
on cancer and diabetes; the effects of any strategic research and
development prioritization initiatives, and any other strategic
alternatives or other efforts that Genprex takes or may take in the
future that are aimed at optimizing and re-focusing Genprex's
diabetes, oncology and/or other clinical development programs
including prioritization of resources, and the extent to which
Genprex is able to implement such efforts and initiatives
successfully to achieve the desired and intended results thereof;
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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/genprex-announces-first-patient-dosed-in-phase-2-expansion-portion-of-acclaim-3-clinical-study-of-reqorsa-gene-therapy-in-combination-with-tecentriq-to-treat-small-cell-lung-cancer-302358445.html
SOURCE Genprex, Inc.
