Chief Medical Officer Provides Overview of
Recent Positive Clinical Patient Outcomes
Video Highlights Recent Oncology Clinical
Development Program Updates
AUSTIN,
Texas, Aug. 15, 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 released a new video
featuring the Company's Chief Medical Officer, Mark Berger, MD, discussing positive clinical
study updates from its Acclaim-1 and Acclaim-3 Phase 1/2 clinical
trials in lung cancer and recent updates to the Company's oncology
clinical development program.
Click here to watch the video.
The Acclaim-1 clinical trial is evaluating the combination of
the Company's lead drug candidate, Reqorsa® Gene Therapy, and
AstraZeneca's Tagrisso® to treat patients with late-stage NSCLC who
have activating EGFR mutations and disease progression after
treatment with Tagrisso.
The Acclaim-3 clinical trial is evaluating the combination of
REQORSA and Genentech's Tecentriq® as a maintenance therapy to
treat 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.
Dr. Berger remarked on the two positive patient outcomes in
Acclaim-1:
"Both of these patients' outcomes are fairly
remarkable in terms of their prolonged Progression Free Survival
(PFS) among patients in the study who were progressing on their
previous treatment when they came into the study. It's very
compelling, particularly, that one of those patients has maintained
this benefit for more than two years. And over time, the patients'
side effects with the combination of REQORSA and Tagrisso have
diminished rather than increased over time."
Dr. Berger's commentary on the positive patient outcome in
Acclaim-3:
"In the Acclaim-3 study, the first patient
treated in the Phase 1 dose escalation portion of the trial has had
a positive response since enrollment and starting maintenance
therapy. The patient has a partial remission (PR) from the start of
maintenance therapy until after the second course, which is when
the first CT scan is done. This is the first dose group in this
study, and there is a second higher dose group to come. The
patient's response is remarkable, and it is very unusual to have a
PR during maintenance therapy. We believe these results bode very
well for the study."
On recent updates to the Company's oncology clinical
development program, Dr. Berger stated:
"To build on these
positive patient results, we are making changes to our clinical
development program both in the Acclaim-1 and Acclaim-2 studies. In
the Acclaim-1 study, we are removing one of the cohorts in Phase
2a, which will allow us to advance more quickly. The Acclaim-2
study is being closed to further enrollment. It has been slow to
enroll patients, mainly because there are hundreds of other very
similar studies that evaluate new treatments after patients have
progressed on Keytruda®. We certainly intend to continue to treat
patients in this study until they have disease progression. We also
believe closing to further enrollment is the right thing to do so
that we can focus our limited resources on the fastest way to being
able to enroll patients and get clinical data.
We're very excited by these positive patient responses, and we
look forward to advancing REQORSA through the clinic. We believe
that streamlining our efforts to do so is the best way to use our
resources and to move our program forward."
To watch the video, please visit Genprex's website at
https://www.genprex.com/videos/.
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:
the initial patient responses to REQORSA treatments and the
potential and promise of these responses, which are demonstrating
early evidence of efficacy with a favorable safety
profile; 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; the effects of any strategic research and
development prioritization initiatives, and any other efforts that
Genprex takes or may take in the future that are aimed at
optimizing and re-focusing Genprex's 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-releases-new-video-featuring-chief-medical-officer-discussing-positive-patient-outcomes-in-two-lung-cancer-clinical-trials-302223226.html
SOURCE Genprex, Inc.