Demonstrates Prolonged Progression Free
Survival of Two Patients in Acclaim-1 and Partial Remission
from Maintenance Therapy in Acclaim-3
Re-focuses Oncology Clinical Development
Program and Advances Work to Establish Biomarkers to Enrich
Clinical Trial Patient Populations
AUSTIN,
Texas, Aug. 14, 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 positive
clinical study updates for its Acclaim-1 and Acclaim-3 clinical
trials for the treatment of non-small cell lung cancer (NSCLC) and
small cell lung cancer (SCLC), respectively, and plans to re-focus
its oncology clinical development program.
Patients in the Company's lung cancer clinical trials are being
treated with the Company's lead drug candidate, Reqorsa®
(quaratusugene ozeplasmid) Gene Therapy. Two patients in the
Acclaim-1 study have had prolonged Progression Free Survival (PFS)
and importantly, the first treated patient in the Acclaim-3 study
attained a Partial Remission (PR) from the start of maintenance
therapy.
Ryan Confer, President and
Chief Executive Officer of Genprex, commented on the
update:
"We are excited by these early and promising patient
responses to REQORSA treatment, particularly as these patients
represent some of the most difficult to treat lung cancer patient
populations. There is significant unmet medical need for patients
afflicted with lung cancer, as nearly all patients' disease
progresses following treatment, even when treated with today's most
advanced targeted therapies and immunotherapies. This leaves
patients with limited therapeutic options. We are thrilled our
novel gene therapy treatment for lung cancer, REQORSA, is
demonstrating early evidence of efficacy with a favorable safety
profile. We look forward to continuing to evaluate REQORSA in our
lung cancer clinical trials while we advance our efforts to bring
new therapies to those battling cancer."
Acclaim-1
The Acclaim-1 clinical trial is evaluating the combination of
REQORSA 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-1 clinical
trial has received an U.S. Food and Drug Administration (FDA) Fast
Track Designation for late-stage NSCLC patients whose disease
progressed after treatment with Tagrisso.
Two patients from the Phase 1 dose escalation portion of the
study have had prolonged PFS and are still continuing to receive
treatment on the study. One of them has received the treatment
combination of REQORSA and Tagrisso for more than two years. This
patient, who was previously treated with Tagrisso and chemotherapy
and who continues to receive REQORSA and Tagrisso treatment,
attained a PR after the second course of REQORSA and Tagrisso, and
has maintained this response for more than two years. The second
patient has had stable disease without disease progression for more
than 15 months, and is also continuing to receive REQORSA and
Tagrisso treatment.
Mark Berger, MD, Chief Medical
Officer of Genprex, discussed the positive outcomes:
"We are
very pleased with the positive early efficacy results for these
patients. It is very compelling that one of the patients in our
Acclaim-1 clinical trial has continued to see benefit from REQORSA
treatment for more than two years and it's been documented that the
side effects of REQORSA have diminished, rather than increased,
over time."
The Phase 2a expansion portion of the study was designed to have
two cohorts with 33 patients each. One cohort was for patients who
have previously received only Tagrisso treatment, and one cohort
was for patients who had previously received both Tagrisso
treatment and chemotherapy. Based on resource prioritization and to
focus on the patients for whom REQORSA is most likely to show a
benefit, the Company has decided to limit its enrollment efforts
moving forward to patients who received only prior Tagrisso
treatment and to cease enrollment of the second cohort (patients
who received prior Tagrisso treatment and chemotherapy). The Phase
2a expansion portion of the trial with one cohort is now expected
to enroll approximately 33 patients. The Phase 2b randomized portion of the study, in which
patients progressing on prior Tagrisso treatment will be randomized
1:1 to either REQORSA and Tagrisso combination therapy or to
platinum-based chemotherapy, will remain unchanged.
Genprex will conduct an interim analysis following the treatment
of 19 patients in the Phase 2a expansion portion who had previously
received only Tagrisso treatment. The Company expects to complete
the enrollment of the first 19 patients in the Phase 2a expansion
portion of the study and conduct an interim analysis in the first
half of 2025.
Acclaim-3
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. The FDA
has granted Fast Track Designation for the Acclaim-3 population of
patients and has also granted Orphan Drug Designation for the
treatment of SCLC.
In this study, patients receive maintenance therapy with REQORSA
and Tecentriq until disease progression or unacceptable toxicity is
experienced. Following completion of the Phase 1 dose escalation
portion of the study, which the Company expects to complete during
the second half of 2024, Genprex then expects to start the Phase 2
expansion portion of the study in the second half of 2024.
The first patient treated in the Phase 1 dose escalation portion
of the Acclaim-3 clinical trial experienced an initial positive
response after enrollment and dosing commenced in May. The patient
had a PR, which is defined as at least a thirty percent (30%)
decrease in tumor size, from the time the patient had a baseline CT
scan after induction therapy and prior to the start of maintenance
therapy, to the time of the CT scan performed after two cycles of
maintenance therapy. 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, which suggests that REQORSA may
be providing clinical benefit. A recent CT scan, performed after
four cycles of maintenance therapy (three months), confirms 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 three
months.
Dr. Berger commented on these compelling
results:
"This patient's response was not expected during
maintenance therapy with Tecentriq alone, and we believe these
results are promising and a positive early indication for the
study. Once ES-SCLC patients begin maintenance therapy with
Tecentriq, median PFS is very short; only 2.6 months, and further
tumor regression rarely occurs. The ES-SCLC patient in the
Acclaim-3 clinical trial treated with our combination therapy
experienced PR, but asymptomatic disease progression was diagnosed
by CT scan three months after the start of maintenance therapy. We
find this positive result to be promising, particularly because
this patient was treated with the lower of two doses planned
for the Phase 1 portion of this clinical trial, and we are hopeful
that the combination of REQORSA and Tecentriq will improve outcomes
and help extend the lives of these very difficult to treat lung
cancer patients."
Genprex's novel cancer treatment platform re-expresses tumor
suppressor genes in cancers. Tumor suppressor genes are often
deleted or inactivated early in the process of cancer development.
The key component of REQORSA is a plasmid that expresses TUSC2, a
tumor suppressor gene protein which plays a vital role in cancer
suppression and normal cell metabolism. Nearly 100% of SCLCs have
reduced or no TUSC2 protein expression, and 41% completely lack
TUSC2 protein expression, thus restoring TUSC2 expression in SCLC
has a strong biologic rationale. Nonclinical studies in mice
support the hypothesis that re-expressing the TUSC2 protein in
combination with Tecentriq may lead to improved clinical efficacy
in SCLC.
Oncology Program Update
Mr. Confer and the executive team have evaluated resource
allocations to ensure streamlined, focused strategies to support
expeditious regulatory submissions for REQORSA and will implement
the following changes to the Company's oncology clinical
development plans in order to prioritize resources and focus
on the most promising aspects of the Acclaim-1 and Acclaim-3 lung
cancer clinical trials.
- The Acclaim-2 clinical trial, a Phase 1/2 trial evaluating the
combination of REQORSA and Merck & Co's Keytruda® in
patients with late-stage NSCLC whose disease has progressed after
treatment with Keytruda, will cease enrollment of new NSCLC
patients. Current patients in the Phase 1 dose escalation portion
of the study will continue to be treated until disease progression.
The Company made this decision based on a number of factors,
including enrollment challenges and delays due to competition for
eligible patients with numerous other trials involving the same
patient population.
- As described above, the Company will limit its enrollment
efforts for the Phase 2a expansion portion of the Acclaim-1 study
moving forward to patients who received only prior Tagrisso
treatment and cease enrollment of the second cohort (patients who
received prior Tagrisso treatment and chemotherapy). The Phase 2a
expansion portion of the trial with one cohort is now expected to
enroll approximately 33 patients. The Company continues to evaluate
ways to optimize its clinical and research programs and operational
strategies, as part of its ongoing prioritization initiative.
Commenting on the decision, Mr. Confer stated:
"The
decision to discontinue the Acclaim-2 clinical trial is driven in
part by the fact that there are hundreds of Keytruda combination
lung cancer clinical trials, which made it difficult to recruit
patients and investigators due to the volume of competing trials.
We thank the clinicians and patients who participated in this study
and look forward to potentially reviewing this patient population
again at a future time, as we fully stand behind REQORSA's
potential to treat late-stage NSCLC patients whose disease
progressed after treatment with Keytruda."
Additionally, Genprex reports that the Company is collaborating
with an academic research partner to discover, develop and utilize
biomarkers to:
- select the patient population most likely to respond to
REQORSA;
- predict and measure target engagement; and
- enable decisions on progression of the Company's drug
candidates to the next phase of development.
The Company's academic research partner is currently analyzing
biomarkers that would indicate lack of response in lung cancer that
could enrich the Company's population of responders in its clinical
trials and enhance patient screening and enrollment in order to
increase the likelihood of potential success of the Acclaim
studies.
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 currently 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
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