Expects to Complete Enrollment of Phase 2a
Expansion Study by the end of 2024
Acclaim-1 Study Has FDA Fast Track
Designation
AUSTIN,
Texas, Feb. 5, 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 in January 2024,
the first patient was enrolled and dosed in the Phase 2a expansion
portion of the Company's Acclaim-1 clinical study
of Reqorsa® Therapy (quaratusugene ozeplasmid) in
combination with AstraZeneca's Tagrisso® to treat
patients with late-stage non-small cell lung cancer (NSCLC).
"We are encouraged by the very promising Phase 1 results in the
Acclaim-1 trial, which demonstrated the combination of REQORSA and
Tagrisso was well tolerated at all three dose levels with evidence
of efficacy observed in patients with non-small cell lung cancer
(NSCLC) whose disease has progressed on Tagrisso," stated
Mark Berger, Chief Medical Officer
of Genprex. "We are excited to begin the Phase 2a expansion portion
of Acclaim-1, which will examine the toxicity profiles of different
cohorts as well as efficacy and other clinical endpoints."
Data from the Phase 1 dose escalation portion of the Acclaim-1
study were presented at the 2023 AACR-NCI-EORTC International
Conference for Molecular Targets and Cancer Therapeutics Meeting in
October 2023. The data reported
results from twelve patients with advanced, epidermal growth factor
receptor (EGFR) mutant NSCLC whose disease progressed after
Tagrisso treatment. REQORSA was generally well tolerated, as there
were no dose limiting toxicities.
While the Phase 1 portion of the clinical trial was designed
primarily to assess safety, promising efficacy results were also
observed. One patient at the 0.06 mg/kg dose level, previously
treated with carboplatin, pemetrexed, and Tagrisso, had a partial
remission (PR) by investigator evaluation and treatment is now
ongoing in the trial after 28 cycles, which is approximately 19.5
months. Another patient who is at the 0.09 mg/kg dose level,
previously treated with Tagrisso, had stable disease and treatment
was ongoing after 14 cycles, or approximately 10 months. And a
third patient previously treated with cisplatin, pemetrexed,
carboplatin, and Tagrisso at the 0.12 mg/kg dose level has stable
disease and is continuing to receive REQORSA after 14 cycles, or
approximately 10 months. The extended progression free survival
(PFS) of each of these patients is consistent with long-term PFS
seen in several patients in prior early stage clinical trials of
REQORSA, and is not expected with treatment with Tagrisso alone
after progression on Tagrisso1. PFS is the primary
endpoint of both the Phase 2a expansion portion and the Phase
2b randomized portion of the
Acclaim-1 study.
"Advancing Acclaim-1 marks an important milestone for Genprex.
We are proud of the progress we have made thus far and are
encouraged by REQORSA's potential to improve outcomes for patients
battling NSCLC. We look forward to an interim analysis from the
Phase 2a study in 2025 and expect those results will further
validate our novel gene therapy approach to treating lung cancer
patients," said Rodney Varner,
President, Chairman and Chief Executive Officer at Genprex.
REQORSA, the Company's lead product candidate, is being
evaluated in three clinical trials as a treatment for NSCLC and
small cell lung cancer (SCLC). Each of the three lung cancer
clinical programs has received a Fast Track Designation from the
U.S. Food and Drug Administration (FDA) for the treatment of that
patient population, and the SCLC program has also received an FDA
Orphan Drug Designation.
About Acclaim-1 Clinical Trial
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 Phase 1 dose escalation portion of the Acclaim-1 trial has
been completed. The Phase 2a 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
2b 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
2b 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® Therapy
REQORSA®
(quaratusugene ozeplasmid) for NSCLC and SCLC consists of the TUSC2
gene expressing plasmid encapsulated in non-viral nanoparticles
made from lipid molecules (Genprex's ONCOPREX®
Nanoparticle Delivery System) with a positive electrical charge.
REQORSA is injected intravenously and specifically targets cancer
cells, which generally have a negative electrical charge. REQORSA
is designed to deliver the functioning TUSC2 gene to cancer cells
while minimizing their uptake by normal tissue. 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.
Genprex's strategy is to develop REQORSA in combination with
currently approved therapies and believes that REQORSA's unique
attributes position it to provide treatments that improve on these
current therapies for patients with NSCLC, SCLC, and possibly other
cancers.
Tagrisso® is a registered trademark of AstraZeneca
plc.
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® 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®
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-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 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
1. Cortellini A, Leonetti A, Catino A, et al.
Osimertinib beyond disease progression in T790M EGFR-positive NSCLC
patients: a multicenter study of clinicians' attitudes. Clin Transl
Oncol. 2020;22(6):844-851. doi:10.1007/s12094-019-02193-w
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