Signs an Amended & Restated License
Agreement for Multiple Technologies for Gene Therapy for Type 1
and
Type 2 Diabetes
Forms a Wholly-Owned Subsidiary, Convergen
Biotech, Inc., to Focus Diabetes Program Development
AUSTIN,
Texas, Feb. 18, 2025 /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 the
advancement of its diabetes gene therapy program, including its
relationship and collaboration with the University of Pittsburgh of the Commonwealth System
of Higher Education (Pitt). The parties
have updated and consolidated the Company's existing license
agreements for technologies from Pitt
into a new exclusive license agreement for multiple technologies
relating to the development of a gene therapy product for both T1D
and T2D. Additionally, the Company has formed a wholly-owned
subsidiary, Convergen Biotech, Inc., which will focus on the
Company's diabetes program development.
"We are excited about the advances we are making with our
diabetes gene therapy program, including the updated, consolidated
exclusive license agreement with the University of Pittsburgh for several technology
combinations," said Ryan Confer,
President and Chief Executive Officer at Genprex. "We are also
pleased to have formed our wholly-owned subsidiary. In addition,
we're having ongoing discussions with various patient advocacy
groups. We believe GPX-002 is a highly innovative, emerging
diabetes gene therapy, and we are working to advance this program
toward human clinical trials."
Exclusive License Agreement with the University of Pittsburgh
The new license
agreement consolidates the Company's licensed technologies from
Pitt into a single updated agreement
which replaces the existing license agreements with Pitt. The amended and restated agreement grants
Genprex a worldwide, exclusive license to patent applications and
related technologies and a worldwide, non-exclusive license to use
certain related know-how, all related to a gene therapy for both
T1D and T2D using the genes of the Pdx1 and MafA transcription
factors controlled by insulin, glucagon and MafB promoters. This
license creates a comprehensive panel of gene therapies exclusively
licensed by Genprex for the Company's diabetes gene therapy
program.
"The latest exclusive license agreement synergizes our
pre-existing relationship with the University
of Pittsburgh, strengthens our intellectual property
portfolio for the diabetes gene therapy program and provides
Genprex with valuable rights over multiple diabetes gene therapy
combinations that we believe have the potential to disrupt the
diabetes market," said Thomas
Gallagher, Senior Vice President of Intellectual Property
and Licensing. "These technologies are currently being evaluated in
preclinical studies at the University of
Pittsburgh. As we continue to optimize our construct, we are
making strides toward clinical trials."
The licensed technologies are based on the same general gene
therapy approach under Genprex's original licenses, whereby an
adeno-associated virus vector containing the Pdx1 and MafA genes is
administered directly into the pancreatic duct. In humans, this can
be done with a routine endoscopy procedure. GPX-002 is being
developed using the same construct for the treatment of both T1D
and T2D. In T1D, GPX-002 is designed to work by transforming 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 T2D,
where autoimmunity is not a factor, is believed to rejuvenate and
replenish exhausted beta cells.
Each of these technologies may have the potential to provide
long-term efficacy, potentially changing the course of this disease
for the millions of patients around the world with diabetes. All of
the diabetes technologies licensed from Pitt by Genprex were developed in the laboratory of
George Gittes, MD, Professor of
Surgery and Pediatrics and Chief of the Division of Pediatric
Surgery at the University of Pittsburgh
School of Medicine.
The Company has finalized components of the diabetes construct
and is continuing with its planned preclinical studies. Genprex
plans to request FDA's guidance for the preclinical studies needed
to file an Investigational New Drug (IND) application and initiate
first-in-human studies and is poised for FDA Guidance on
IND-enabling diabetes studies by the second half of 2025.
Formation of a Wholly-Owned Subsidiary
In addition, as
announced in September 2024, Genprex
believes separating its diabetes program from its oncology program
into a new, wholly-owned subsidiary could expedite clinical
development and enable potential direct investment and strategic
collaboration into its diabetes program. In connection with the
intended separation of its diabetes clinical development program,
Genprex has formed a wholly-owned subsidiary, Convergen Biotech,
Inc. Genprex believes implementing this initial step and
facilitating the separation of its diabetes program into Convergen
Biotech will allow both Genprex and Convergen Biotech to enhance
each program's focus on meeting the needs of their respective
markets and patients. The decision to implement this initial step
of the reorganization demonstrates Genprex's strong ongoing
commitment to the Company's streamlined, focused strategies and
prioritization of its ongoing research and development
prioritization initiative.
About Diabetes
According to the U.S. Center for
Disease Control as of 2024, 38.4 million Americans, or
approximately 11.6% of the U.S. population, have diabetes.
Approximately 10% of this total has T1D and approximately 90-95% of
this total has T2D. It is also believed that more than 97 million
Americans aged 18 years or older have prediabetes. In 2021,
approximately 537 million adults (20-79 years) worldwide were
living with diabetes, and the total number of people living with
diabetes is projected to rise to 643 million by 2030 and 783
million in 2045. Approximately 7.7 million adults over the age of
20 live with T1D worldwide, and approximately 1.6 million children
and adolescents under the age of 20 live with T1D worldwide. Also
in 2021, diabetes caused more than 6.7 million deaths globally and
diabetes resulted in approximately $966
billion dollars in health expenditures, a 316% increase over
the preceding fifteen years.
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:
Genprex's ability to advance the clinical development,
manufacturing and commercialization of its product candidates in
accordance with projected timelines and specifications, such as the
Company's diabetes product candidate, GPX-002; the timing and
success of Genprex's clinical trials and regulatory approvals,
including, but not limited to, the Company's diabetes clinical
development program and its ongoing work with Pitt; 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 strategic alternatives or
other efforts that Genprex takes or may take in the future that are
aimed at optimizing and re-focusing Genprex's diabetes, 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, including successful implementation
of the separation of its diabetes clinical development program,
including the anticipated benefits of the internal reorganization,
the expected timing of the reorganization and/or if it is completed
as contemplated or at all; 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.
