Acclaim-1 Phase 1 study had no Dose Limiting
Toxicity, and results establish Phase 2 Recommended Dose as well as
provide data showing efficacy of REQORSA® in combination with
Tagrisso®
Preclinical results show that REQORSA® in
combination with a checkpoint inhibitor has anti-tumor activity in
a humanized mouse model of small cell lung cancer (SCLC)
AUSTIN,
Texas, Oct. 4, 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 research
collaborators will present positive clinical and preclinical data
from studies of its lead product candidate, REQORSA® (quaratusugene
ozeplasmid) used for the treatment of lung cancers, at the 2023
AACR-NCI-EORTC International Conference on Molecular Targets and
Cancer Therapeutics taking place from October 11-15, 2023 at the Hynes Convention
Center in Boston. REQORSA is a
non-viral gene therapy that leads to expression of the TUSC2 tumor
suppressor gene in cancers.
"The encouraging Phase 1 results in the Acclaim-1 trial document
REQORSA's favorable safety profile thus far and show early efficacy
in patients with non-small cell lung cancer (NSCLC) whose disease
has progressed on Tagrisso. Importantly, there were no Dose
Limiting Toxicities. Based on these results, the Safety Review
Committee has recommended that we move forward with the Phase 2
expansion portion of the study, which moves us one step closer to
our goal of bringing this potentially life-saving therapy to
patients," said Rodney Varner,
Chairman, President and Chief Executive Officer at Genprex. "In
addition, the preclinical data presented by our research
collaborators is very encouraging, as we know that despite the
broader success of immunotherapies, such as checkpoint inhibitors,
they have limited efficacy in the treatment of small cell lung
cancer. We look forward to evaluating REQORSA in combination with a
checkpoint inhibitor to treat SCLC in our upcoming Acclaim-3
clinical trial, where we have both FDA Fast Track and Orphan Drug
Designations for this patient population."
Details of the presentations are outlined below:
Title:
|
"Completion of
Acclaim-1 dose escalation: Recommended Phase 2 dose of
quaratusugene ozeplasmid gene therapy and osimertinib"
|
Poster
Number:
|
AO65
|
Date/Time:
|
Thursday, October 12,
2023 from 12:30 pm – 4:00 pm ET
|
Presenter:
|
Alexander I. Spira,
M.D., PhD, Virginia Cancer Specialists, Fairfax, VA
|
Dr. Spira's presentation will focus on the results of the Phase
1 dose escalation portion of the Acclaim-1 clinical trial of
REQORSA in combination with Tagrisso® (osimertinib) to treat
late-stage NSCLC. Results showed REQORSA was generally well
tolerated with no Dose Limiting Toxicities. Of the 12 patients
treated with escalating doses of REQORSA and standard doses of
Tagrisso, all of whom had progressed on Tagrisso containing
regimens, two patients experienced prolonged time to progression,
including one with continuing partial response. While REQORSA
administration was associated with delayed infusion-related
reactions of muscle aches, fever and chills in some patients, this
was managed with prophylactic steroids, acetaminophen and
diphenhydramine, and symptoms decreased with repeat cycles.
The study's Safety Review Committee met and determined that the
recommended Phase 2 dose for REQORSA in combination with Tagrisso
in patients with NSCLC progressing after Tagrisso treatment will be
0.12 mg/kg. This was the highest dose level delivered in the Phase
1 portion and is twice the highest dose level delivered in
Genprex's prior clinical trial combining REQORSA with Tarceva®
(erlotinib) for the treatment of late-stage NSCLC. The SRC also
recommended the trial advance to the Phase 2 expansion portion of
the study.
The combination of REQORSA and Tagrisso received U.S. Food and
Drug Administration's (FDA) Fast Track Designation for treatment of
the Acclaim-1 patient population.
Title:
|
"TUSC2 immunogene
therapy enhances checkpoint blockade through increased cytotoxic
immune activation in chemo-resistant small cell lung cancer (SCLC)
in humanized mice"
|
Poster
Number:
|
AO66
|
Date/Time:
|
Thursday, October 12,
2023 from 12:30 pm – 4:00 pm ET
|
Presenter:
|
Ismail Meraz, Ph.D.,
Senior Research Project Manager, The University of Texas MD
Anderson Cancer Center
|
The study evaluated REQORSA, referred to as TUSC2 gene therapy
in the abstract, in combination with the immune checkpoint
inhibitor Tecentriq® (atezolizumab) for the treatment of
chemotherapy resistant SCLC tumors in humanized mice. The use of
humanized mice allowed an evaluation of the human immune cell
subtypes that infiltrated the tumor.
Study authors concluded that TUSC2 expression is reduced in
almost all SCLC tumors and absent in 41%. The researchers
investigated the antitumor response to TUSC2 gene therapy in
combination with Tecentriq. The data show that TUSC2 gene therapy
in combination with Tecentriq induces strong antitumor activity in
a chemo-resistant SCLC through cytotoxic CD8 T- and NK-cell
activation, as the study found that CD8 T and NK-cell infiltration
in the tumor was increased by REQORSA.
The combination of REQORSA and the checkpoint inhibitor
Tecentriq received FDA Fast Track and Orphan Drug Designations for
treatment of the Acclaim-3 patient population.
Genprex's ONCOPREX® Nanoparticle Delivery System is a novel
non-viral approach utilizing lipid nanoparticles to deliver tumor
suppressor genes that have been deleted during the course of cancer
development. The platform allows for the intravenous delivery of
various tumor suppressor genes, and potentially other genes, to
achieve a therapeutic affect without the risk of the type of
toxicity often associated with viral delivery systems.
The aforementioned 2023 AACR-NCI-EORTC posters will be available
on Genprex's website here following the completion of their live
presentations.
About the Acclaim Clinical Trials in Lung Cancers
Genprex currently has three clinical trials evaluating the
Company's lead drug candidate, REQORSA® (quaratusugene ozeplasmid)
in lung cancer. The Acclaim-1 clinical trial, whose patient
population received FDA Fast Track Designation, is an open-label,
multi-center Phase 1/2 clinical trial evaluating REQORSA in
combination with Tagrisso® (osimertinib) in patients with
late-stage NSCLC with activating epidermal growth factor receptor
mutations whose disease progressed after treatment with Tagrisso.
The Acclaim-2 clinical trial, whose patient population received FDA
Fast Track Designation, is an open-label, multi-center Phase 1/2
clinical trial evaluating REQORSA in combination with Keytruda®
(pembrolizumab) in patients with late-stage NSCLC whose disease
progressed after treatment with Keytruda. The upcoming Acclaim-3
clinical trial is an open-label, multi-center Phase 1/2 clinical
trial evaluating REQORSA in combination with Tecentriq®
(atezolizumab) as maintenance therapy in patients with
extensive-stage SCLC who did not develop tumor progression after
receiving Tecentriq and chemotherapy as an initial treatment. The
FDA granted both Fast Track and Orphan Drug Designation for REQORSA
in the Acclaim-3 patient population.
About REQORSA® Immunogene 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.
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® (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). 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
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 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
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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