Genprex Expands Manufacturing Program with Aldevron to Advance Oncoprex™ Clinical Development
June 16 2020 - 8:17AM
Business Wire
Expansion enables full commercial scale plasmid
DNA manufacturing capabilities
Manufacturing program supports upcoming
clinical trials, including Oncoprex in combination with Tagrisso®,
which received FDA Fast Track Designation
Genprex, Inc. (“Genprex” or the “Company”) (Nasdaq: GNPX), a
clinical-stage gene therapy company developing potentially
life-changing technologies for patients with cancer and diabetes,
announced today that it has expanded its program for the
manufacture of TUSC2 (Tumor Suppressor Candidate 2) plasmid DNA for
its lead drug candidate, Oncoprex™ immunogene therapy, by entering
into a new agreement with manufacturing partner Aldevron, LLC,
(“Aldevron”). The new agreement provides for production of TUSC2
plasmid DNA, the active agent in Oncoprex, at full commercial
scale. The Company’s manufacturing at this scale should also result
in significantly lower costs per unit of product manufactured due
to economies of scale.
Genprex’s upcoming clinical trials include a Phase I/II trial of
Oncoprex combined with osimertinib (marketed by AstraZeneca as
Tagrisso®) for non-small cell lung cancer (NSCLC), which received
Fast Track Designation in January 2020 and is expected to be
initiated in early 2021. A clinical trial of Oncoprex in
combination with pembrolizumab (marketed by Merck as Keytruda®) in
NSCLC is also planned.
“We are pleased with continued progress in the scale-up of our
manufacturing processes. This new agreement with Aldevron increases
our manufacturing capabilities in support of our clinical trials
utilizing Oncoprex immunogene therapy in combination with targeted
therapies and immunotherapies against lung cancer,” said Rodney
Varner, Chairman and Chief Executive Officer of Genprex.
“Our team is excited about the expansion of our manufacturing
agreement and elevation of our long-standing relationship with
Genprex,” said Michelle Berg, President of GMP Nucleic Acids at
Aldevron. “Aldevron’s GMP facility and campus buildout ensures we
can meet the future manufacturing demands of companies experiencing
significant growth such as Genprex; thereby enabling our ultimate
goal of impacting the lives of patients.”
Oncoprex consists of TUSC2 plasmid DNA encapsulated in a lipid
nanoparticle. The TUSC2 gene is the active agent in Oncoprex. Data
indicate that the resultant product when transfected into cancer
cells both induces cell signaling that triggers programmed cell
death and modulates the immune system so that the cancer cells are
more susceptible to treatment.
About Aldevron
Aldevron serves the biotechnology industry offering in-stock
products and custom production of nucleic acids, proteins, and
antibodies. Thousands of clients use Aldevron-produced plasmids,
RNA and gene editing enzymes for projects ranging from discovery
research to clinical trials to commercial applications. These
products are critical raw materials and key components in
commercially available drugs and medical devices. Aldevron
specializes in GMP manufacturing and is known for inventing the
GMP-Source™ quality system. It is currently constructing a second
manufacturing site on its headquarter campus in Fargo, North
Dakota, more than doubling its production capacity. It has
additional facilities in Madison, Wisconsin, and Freiburg, Germany.
To learn more, visit www.aldevron.com.
About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company
developing potentially life-changing technologies for patients with
cancer and diabetes. Genprex’s technologies are designed to
administer disease-fighting genes to provide new treatment options
for large patient populations with cancer and diabetes who
currently have limited treatment options. Genprex works with
world-class institutions and collaborators to in-license and
develop drug candidates to further its pipeline of gene therapies
in order to provide novel treatment approaches. The Company’s lead
product candidate, Oncoprex™, is being evaluated as a treatment for
non-small cell lung cancer (NSCLC). Oncoprex has a multimodal
mechanism of action that has been shown to interrupt cell signaling
pathways that cause replication and proliferation of cancer cells;
re-establish pathways for apoptosis, or programmed cell death, in
cancer cells; and modulate the immune response against cancer
cells. Oncoprex has also been shown to block mechanisms that create
drug resistance. In January 2020, the U.S. Food and Drug
Administration granted Fast Track Designation for Oncoprex
immunogene therapy for NSCLC in combination therapy with
osimertinib (AstraZeneca’s Tagrisso®) for patients with EFGR
mutations whose tumors progressed after treatment with osimertinib
alone. For more information, please visit the Company’s web site at
www.genprex.com or follow Genprex on Twitter, Facebook and
LinkedIn.
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. Because such 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 effect of Genprex’s product candidates, alone and in
combination with other therapies, on cancer and diabetes, regarding
potential, current and planned clinical trials, regarding the
Company’s future growth and financial status and regarding our
commercial partnerships and intellectual property licenses. Risks
that contribute to the uncertain nature of the forward-looking
statements include the presence and level of the effect of our
product candidates, alone and in combination with other therapies,
on cancer; the timing and success of our clinical trials and
planned clinical trials of Oncoprex™, alone and in combination with
targeted therapies and/or immunotherapies, and whether our other
potential product candidates, including our gene therapy in
diabetes, advance into clinical trials; the success of our
strategic partnerships, including those relating to manufacturing
of our products; the timing and success of obtaining FDA approval
of Oncoprex™ and our other potential product candidates including
whether we receive fast track or similar regulatory designations;
costs associated with developing our product candidates and whether
patents will ever be issued under patent applications that are the
subject of our license agreements. These and other risks and
uncertainties are described more fully under the caption “Risk
Factors” and elsewhere in our filings and reports with the United
States Securities and Exchange Commission. All forward-looking
statements contained in this press release speak only as of the
date on which they were made. We undertake no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made.
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Genprex, Inc. (877) 774-GNPX (4679)
Investor Relations GNPX Investor Relations (877) 774-GNPX
(4679) ext. #2 investors@genprex.com
Media Contact Genprex Media Relations Kalyn Dabbs (877)
774-GNPX (4679) ext. #3 media@genprex.com
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