Genprex™ Manufacturing Partner Aldevron Completes Significant Step in Manufacturing for Oncoprex™ Clinical Development Pr...
August 06 2019 - 08:00AM
Business Wire
Newly manufactured plasmids will be used in
clinical trials evaluating Oncoprex™ in combination with targeted
therapies and immunotherapies
Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy
company, announced that its manufacturing partner, Aldevron, has
successfully completed the manufacturing of the TUSC2 (Tumor
Suppressor Candidate 2) plasmid DNA pursuant to the manufacturing
agreement between Genprex and Aldevron that was announced in
September 2018.
Genprex’s initial product candidate, Oncoprex™ consists of a
TUSC2 plasmid DNA manufactured by Aldevron encapsulated in a
nanovesicle made from lipid molecules with a positive electrical
charge. Historically, the manufacturing steps of combining the
plasmid DNA with the lipid nanovesicles of Oncoprex, has been done
for Genprex at MD Anderson Cancer Center. Since Genprex’s IPO, the
company has been working to transfer and scale up these processes
through other contract manufacturers.
“Each successful release of plasmid DNA batches is an important
milestone for Genprex as it allows us to not only demonstrate
continued progress in coordinating scale-up manufacturing of
Oncoprex, but it takes us one step closer to re-entering the clinic
with both our EGFR program and our immunotherapy combination
programs. Biologics manufacturing, especially for lipid
nanoparticle (or LNP) delivered gene therapy, is a complex process,
but one we tackle with pride alongside dedicated partners such as
Aldevron, through a similar vision to deliver innovative therapies
to patients with significant unmet medical needs,” said Julien
Pham, MD, Genprex’s President and Chief Operating Officer.
The U.S. Food and Drug Administration (FDA) has made
manufacturing a top priority for cell and gene therapy companies.
The FDA’s former Commissioner, Scott Gottlieb, noted in 2018 that
the agency devotes approximately 80 percent of its focus during
reviews of gene therapy candidates to manufacturing and quality
concerns. FDA’s Director of the Center for Drug Evaluation and
Research, Janet Woodcock, M.D., noted in July 2019 that the agency
is adapting to the flood of new drug applications stemming from
advances in gene therapy and is shifting its stance toward drug
development more than in recent years. This shift emphasizes the
need for gene therapy companies to not only demonstrate clinical
efficacy but also be able to manufacture these drugs on a large
scale.
Genprex has made manufacturing one of its top priorities since
its IPO in 2018. During that time, Genprex has been building out
its manufacturing process development to support this expansion and
advance its commercial scaling capabilities.
Earlier this year, Genprex strengthened its senior team with the
appointment of Eric Chapdelaine as Senior Director of
Pharmaceutical Sciences and Manufacturing to support the company’s
manufacturing, technical operations, and supply chain
management.
About Genprex, Inc.
Genprex, Inc. is a clinical stage gene therapy company
developing potentially life-changing technologies for cancer
patients, based upon a unique proprietary technology platform,
including Genprex’s initial product candidate, Oncoprex™ immunogene
therapy for non-small cell lung cancer (NSCLC). Genprex’s platform
technologies are designed to administer cancer fighting genes by
encapsulating them into nanoscale hollow spheres called
nanovesicles, which are then administered intravenously and taken
up by tumor cells where they express proteins that are missing or
found in low quantities. Oncoprex 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, or programmed cell death, in cancer cells,
and modulates the immune response against cancer cells. Oncoprex
has also been shown to block mechanisms that create drug
resistance. 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 TUSC2 on cancer, the effect of products and services
provided by Aldevron and our other commercial partners on the
development of Oncoprex™, the build-out, transfer and scale-up of
our manufacturing processes, our current and planned clinical
trials, and the commercialization of our product candidates. Risks
that contribute to the uncertain nature of the forward-looking
statements include the presence and level of TUSC2’s effect on
cancer, our ability to utilize the products and services of
Aldevron and our other commercial partners, the ability of those
products and services to influence the development of Oncoprex™,
our ability to successfully build-out and scale-up our
manufacturing process, our ability to successfully transfer
manufacturing processes to commercial maufacturers, as well as the
timing and success of our clinical trials and planned clinical
trials of TUSC2 and Oncoprex™ and our other potential product
candidates and the timing and success of obtaining FDA approval of
Oncoprex™ and our other potential product candidates. 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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