Acclaim-1 Phase 2a and Acclaim-3 Phase 1
clinical studies opening for enrollment in January 2024
Poised for FDA guidance regarding diabetes
gene therapy program in 2024
AUSTIN,
Texas, Jan. 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 provides a review of its
2023 achievements and a preview of plans for advancing its diabetes
and oncology gene therapy programs in 2024.
"We are very proud of what we accomplished in 2023, particularly
with the successful completion of the Phase 1 portion of our
Acclaim-1 clinical trial in lung cancer," said Rodney Varner, Chairman, President and Chief
Executive Officer at Genprex. "In 2023, we also received a third
Fast Track Designation for Reqorsa® Immunogene Therapy
from the U.S. Food and Drug Administration, this time in
combination with Tecentriq® for the treatment of small
cell lung cancer, and REQORSA was also granted Orphan Drug
Designation for the treatment of small cell lung cancer. We believe
these designations underscore and further validate the potential of
REQORSA. Our accomplishments in 2023, which also include process
improvements in our manufacturing operations and securing new
supplies of REQORSA, sets the foundation for a strong 2024."
Oncology Gene Therapy Platform
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"), and each of the three lung cancer
clinical programs has received a Fast Track Designation from the
FDA for the treatment of that patient population.
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
apoptosis (programmed cell death) in cancer cells, and
modulates the immune response against cancer cells. In early
studies, REQORSA has been shown to be complementary with targeted
drugs and immunotherapies. 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.
Important events of the year included:
- In April, at the 2023 Annual Meeting of the American
Association for Cancer Research (AACR 2023), Genprex collaborators
presented preclinincal gene therapy data with NPRL2, another tumor
suppressor gene, that further validates the ONCOPREX Nanoparticle
Delivery System as a platform
- In October, Genprex hosted a Key Opinion Leader virtual event,
"Bringing Gene Therapy to the Fight Against Lung Cancers" which
discussed the use of gene therapies, including REQORSA, in the
fight against lung cancer
- In December, Genprex completed the successful production of a
new batch of REQORSA thereby securing REQORSA supply for its
Acclaim clinical studies
- Collaborators submitted abstracts in 2023 and are expecting to
present data at the American Association for Cancer Research (AACR)
Meeting in April 2024
Acclaim-1:
The Acclaim-1 study is a Phase 1/2 clinical trial that has three
portions - a Phase 1 dose escalation which has been completed, a
Phase 2a expansion, and a Phase 2b
randomized portion. Acclaim-1 uses a combination of REQORSA and
AstraZeneca's Tagrisso® in patients with late-stage
NSCLC that has activating epidermal growth factor receptor
mutations and progression after treatment with Tagrisso. This novel
approach to targeting lung cancer has demonstrated a strong safety
profile with early signs of efficacy.
- In May, Genprex completed the Phase 1 portion of the Acclaim-1
clinical trial and reported encouraging results. The Acclaim-1
Phase 1 study had no Dose Limiting Toxicities and results
established a Phase 2 Recommended Dose, as well as provided data
showing efficacy of REQORSA in combination with
Tagrisso®
- In May, after completion of the Phase 1 portion of the
Acclaim-1 trial, the Safety Review Committee ("SRC") approved
advancement from the Phase 1 dose escalation portion of the trial
to the Phase 2a expansion portion of the trial
- In October, clinical collaborators presented a poster
presentation at the 2023 AACR-NCI-EORTC International Conference on
Molecular Targets and Cancer Therapeutics showing the Phase 1
results of the Acclaim-1 study
- In January 2024, Genprex expects
to open the Phase 2a expansion portion of the Acclaim-1 study for
enrollment
- Genprex expects to complete the enrollment of 19 patients in
each cohort of the Phase 2a expansion portion of the study by the
end of 2024
Acclaim-2:
The Acclaim-2 study is a Phase 1/2 clinical trial that has three
portions - a Phase 1 dose escalation portion, a Phase 2a expansion
portion, and a Phase 2b randomized
portion. The Acclaim-2 trial uses a combination of REQORSA and
Merck & Co.'s Keytruda® in patients with late-stage
NSCLC whose disease has progressed after treatment with Keytruda.
Patients are treated at the 0.06 mg/kg dose level in the first
cohort of patients and, subject to the Acclaim-2 SRC approval, will
be treated at successive dose levels of 0.09 mg/kg and 0.12
mg/kg.
- Expanding on the previously granted patents in the U.S.,
Japan, Mexico and Russia, Genprex was granted patents in
Australia, Chile and China to cover the use of REQORSA in
combination with immune checkpoint inhibtors, e.g., PD1 and PDL1
inhibitors. These patents are applicable to Genprex's Acclaim-2 and
Acclaim-3 clinical trials.
- In the second half of 2024, Genprex expects to complete
enrollment in the Phase 1 dose escalation portion of the Acclaim-2
study
Acclaim-3:
The Acclaim-3 study has two portions - a Phase 1 dose escalation
portion and a Phase 2 expansion portion. In November 2022 Genprex filed with the FDA the
protocol for the Phase 1/2 Acclaim-3 clinical trial using a
combination of REQORSA and Genentech, Inc.'s Tecentriq®
as maintenance therapy for patients with extensive stage small cell
lung cancer ("ES-SCLC") who develop tumor progression after
receiving Tecentriq and chemotherapy as initial standard treatment.
Patients will be treated with REQORSA and Tecentriq until disease
progression or unacceptable toxicity is experienced.
- In June, the FDA granted Fast Track Designation for the
Acclaim-3 treatment combination of REQORSA and Tecentriq as
maintenance therapy in patients with ES-SCLC who did not develop
tumor progression after receiving Tecentriq and chemotherapy as
initial standard treatment
- In August, the FDA granted Orphan Drug Designation to REQORSA
for the treatment of SCLC
- In January 2024, Genprex expects
to open the Phase 1 portion of the Acclaim-3 study for enrollment,
and expects to complete the Phase 1 portion of the study by the
second half of 2024
- In the second half of 2024, Genprex expects to start the Phase
2 portion of the Acclaim-3 study
Diabetes Gene Therapy Platform
Genprex's diabetes gene therapy approach is comprised of an
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. Genprex has
exclusively licensed from the University of
Pittsburgh of the Commonwealth System of Higher Education
("University of Pittsburgh") multiple
technologies relating to the development of a gene therapy product
for each of Type 1 and Type 2 diabetes. In October 2023, Genprex entered into a one-year
extension to the August 2022
sponsored research agreement with the University of Pittsburgh. The extension includes a
revised research plan to encompass the Company's most recent
technologies to which Genprex acquired exclusive rights from the
University of Pittsburgh in
July 2023. These include a MafB
promoter to drive expression of the Pdx1 and MafA transcription
factors that can potentially be used for both Type 1 and Type 2
diabetes. This research is expected to be initially conducted in a
Type 1 animal model.
- In February, Genprex's research collaborators at the University
of Pittsburgh presented preclinical data in a NHP model of Type 1
diabetes highlighting the therapeutic potential of GPX-002. These
data, presented during an oral presentation at the 16th
International Conference on Advanced Technologies & Treatments
for Diabetes (ATTD 2023), showed statistically significant
decreases in insulin requirements, increased c-peptide levels and
improved glucose tolerance compared to baseline.
- In April, the Company hosted a Key Opinion Leader virtual
event, "Novel Gene Therapy to Treat Type 1 Diabetes," which
discussed preclinical data reported at ATTD 2023 supporting gene
therapy to treat Ttype 1 diabetes
- Finalized the components of the diabetes construct to take
forward for nonclinical studies
- In December, Genprex submitted a request to meet with the FDA
to obtain their guidance on the nonclinical studies needed to file
an Investigational New Drug application and initiate first-in-human
studies. As a result of the FDA's response, the Company will
continue with its planned additional nonclinical studies before
requesting regulatory guidance in 2024 for the IND-enabling
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® 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
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SOURCE Genprex, Inc.