Genprex Completes Phase 1 Dose Escalation
Portion of Acclaim-3 Clinical Trial
Results from Phase 1 Dose Escalation
Demonstrate Favorable Safety Profile of REQORSA and Tecentriq in
ES-SCLC Patients
AUSTIN, Texas , Dec. 16,
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 it has completed the
Phase 1 dose escalation portion of the Acclaim-3 clinical trial of
Reqorsa® Gene Therapy (quaratusugene ozeplasmid) in combination
with Tecentriq® (atezolizumab) as maintenance therapy to treat
patients with extensive stage small cell lung cancer (ES-SCLC). In
addition, the Safety Review Committee (SRC) has approved the
opening of the Phase 2 expansion portion of the trial.
The combination of REQORSA and atezolizumab previously received
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.
Based on full safety data, which showed no dose limiting
toxicities (DLTs), the SRC determined that the Recommended Phase 2
Dose (RP2D) of REQORSA will be 0.12 mg/kg. This was the highest
dose level delivered in the Phase 1 portion of the trial. The SRC
also recommended the trial advance to the Phase 2 expansion portion
of the study, which the Company has now opened for enrollment.
"We are pleased to complete the Phase 1 dose escalation portion
of the Acclaim-3 clinical trial and to have now opened the Phase 2
expansion portion of Acclaim-3 for enrollment in the second half of
2024, in accordance with our previously disclosed guidance for
timing and milestones," said Ryan
Confer, President and Chief Executive Officer at Genprex.
"Our partnership with a large network of community-based oncology
practices has allowed us to have successful enrollment rates,
enabling Genprex to meet our 2024 timeline targets for this study.
In adding multiple clinical trial sites to our Acclaim-3 study, we
have been able to more efficiently and expeditiously accelerate the
Acclaim-3 clinical trial. Looking ahead, we believe this sets
the stage for potential promising enrollment rates for the Phase 2
portion of the trial. Additionally, we will be submitting the
results of the Phase 1 portion of the study to a clinical meeting
and anticipate data presentation in 2025, and we remain encouraged
by the early efficacy demonstrated in ES-SCLC patients."
Genprex previously reported the first patient treated in the
Phase 1 dose escalation portion of the Acclaim-3 trial had a
partial remission, which is defined as at least a thirty percent
(30%) decrease in tumor size, from prior to the start of
maintenance therapy to the time of the CT scan performed after two
cycles of maintenance therapy. A CT scan performed after four
cycles of maintenance therapy (three months), confirmed that the
patient had a 30% decrease in tumor size in measurable lesions;
however, one lesion not previously measurable had grown in size,
thus leading to a conclusion of disease progression at that time.
As the maintenance therapy consists of REQORSA and Tecentriq, and
the patient had already received four cycles of Tecentriq during
induction therapy and thus responses to Tecentriq would likely have
occurred earlier, the Company believes this suggests that REQORSA
may be providing clinical benefit.
In the Phase 1 dose escalation portion of the Acclaim-3 clinical
trial, patients were treated with REQORSA and Tecentriq until
disease progression or unacceptable toxicity was experienced. The
primary endpoint of the Phase 1 escalation portion was to determine
the Maximum Tolerated Dose (MTD) or RP2D.
The SRC is comprised of three physicians who are principal
investigators in the trial. Based on the preliminary safety data
from patients in the 0.12 mg/kg dose level, the SRC recommended
that the 0.12 mg/kg dose be the RP2D that will be used in the Phase
2 portion of the trial and that the Phase 2 trial be opened for
enrollment.
The Phase 1 dose escalation portion of the trial had two dose
groups: 0.09 mg/kg and 0.12 mg/kg.The Phase 2 expansion portion
will enroll approximately 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
futility analysis will be performed after the 25th patient enrolled
and treated reaches 18 weeks of follow up.
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 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
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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, 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 Phase 1 dose escalation and 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
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