Results Show Combination of REQORSA® and
Tagrisso® was Well Tolerated at All Three Dose Levels of Phase 1
Trial with Encouraging Evidence of Efficacy Observed
AUSTIN,
Texas, May 25, 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 positive
data from the Phase 1 portion of its Acclaim-1 clinical trial
evaluating REQORSA® Immunogene Therapy in combination with
Tagrisso® in late-stage non-small cell lung cancer (NSCLC) were
published in an abstract at the 2023 American Society of Clinical
Oncology (ASCO) Annual Meeting, taking place June 2-6, 2023 in Chicago, IL and online.
"We are thrilled to have our abstract, which reports positive
results from the Phase 1 portion of our Acclaim-1 clinical trial,
published at the ASCO Annual meeting," said Mark Berger, MD, Chief Medical Officer at
Genprex. "We are encouraged by the favorable safety profile of
REQORSA, as well as the preliminary efficacy data we have observed,
and we believe this data will support our advancement to the Phase
2 portion of the clinical trial."
Details of the abtract are below:
Abstract Number:
e15081
Title: ACCLAIM-1 dose escalation: Determination of quaratusugene
ozeplasmid and osimertinib recommended phase 2 dose (RP2D)
Session Title: Publication Only: Developmental
Therapeutics—Molecularly Targeted Agents and Tumor Biology
Track: Developmental Therapeutics—Molecularly Targeted Agents and
Tumor Biology
The abstract reports preliminary results from eight patients in
Genprex's Phase 1 portion of its Acclaim-1 clinical trial
evaluating REQORSA Immunogene Therapy (quaratusugene ozeplasmid)
with Tagrisso (osimertinib) in patients with advanced, EGFR mutant
NSCLC whose disease progressed after Tagrisso. REQORSA was
generally well tolerated, as there were no dose limiting
toxicities. Full safety and efficacy data on the Phase 1 portion of
the study will be presented at an upcoming medical meeting.
While the Phase 1 portion of the clinical trial is 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 osimertinib, had a
partial remission (PR) by investigator evaluation and treatment is
ongoing after 16 cycles, which is approximately 10.5 months.
Another patient at the 0.09 mg/kg dose level, previously treated
with osimertinib, has stable disease and treatment is ongoing after
14 cycles, or approximately 9 months. The extended and ongoing
progression free survival (PFS) of each of these patients is
significantly greater than the median PFS observed from treatment
with osimertinib alone in this treatment setting in several prior
clinical trials1 and is consistent with long-term PFS
seen in prior clinical trials of REQORSA. PFS is the primary
endpoint of both the Phase 2 expansion portion and the Phase 2
randomized portion of the Acclaim-1 trial.
"Demonstrating a favorable safety profile substantially de-risks
the REQORSA development program and is a major accomplishment for
Genprex," said Rodney Varner,
Chairman, President and Chief Executve Officer of Genprex. "It is
encouraging that several patients who were progressing on their
previous therapy are now having long periods of response and stable
disease in the Phase 1 portion of the study. We wish to thank the
patients and investigators participating in our clinical trials and
our investors who make it possible to move our drug candidates
forward toward availability for patients in need."
1. CHRYSALIS-2 NSCLC clinical trial data
reported at ASCO 2022
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 25 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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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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