Genprex Completes Manufacturing Scale-Up for Clinical-Grade Production of REQORSA™ Immunogene Therapy for Upcoming Acclaim-...
December 22 2020 - 9:32AM
Business Wire
Major Manufacturing Milestone Positions the
Company for Success In the Lung Cancer Therapeutics Market,
expected to grow to $26.3 Billion by 2023
Achievement Highlighted by Important Process
Improvements and Significantly Improved Economies of Scale
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,
announced today that it has completed the manufacturing scale-up of
REQORSA™ immunogene therapy. The clinical-grade production is
intended to supply the Company’s upcoming Acclaim-1 and Acclaim-2
clinical trials for the treatment of non-small cell lung cancer,
subject to passing final testing that is currently underway. The
Company recently announced the successful manufacturing technology
transfer to commercial Contract Development and Manufacturing
Organizations (CDMOs) and the successful engineering run of
REQORSA, that passed all testing specifications.
For the first time, REQORSA was manufactured in a scaled-up
clinical production in accordance with the current Good
Manufacturing Practices (cGMP) required by the U.S. Food and Drug
Administration (FDA) in advance of commercial approval of a drug
product. This product will supply the Company’s upcoming Acclaim-1
and Acclaim-2 clinical trials that combine REQORSA with Tagrisso®
(marketed by AstraZeneca) and with Keytruda® (marketed by Merck
& Co., Inc.), respectively, both of which are on track to be
initiated in the first-half of 2021. This production includes
process improvements that resulted in significantly higher yields
and lower costs than prior manufacturing campaigns. Previously,
REQORSA was manufactured at the major cancer research institution
where it was invented.
“The scaled-up production of clinical-grade REQORSA is yet
another significant manufacturing milestone for the Company,” said
Michael Redman, Executive Vice President and Chief Operating
Officer of Genprex. “Utilizing advanced processes, we were able to
successfully improve our production yield multi-fold with
significantly improved economies of scale. This production is
intended to provide REQORSA for our upcoming Acclaim clinical
trials. Furthermore, this achievement positions Genprex with the
manufacturing capability for potential future commercialization in
the rapidly growing lung cancer therapeutics market, which is
projected to grow to $26.3 billion by 2023.”
Upon completion of testing and lot release, REQORSA will be
transported to cold storage depots. These depots will facilitate
shipments to the clinical trial sites following FDA clearance to
commence the upcoming clinical trials. Unlike some biologicals that
require shipment and storage at -80°C temperatures, REQORSA
requires storage at only 2-8°C.
REQORSA is comprised of TUSC2 plasmid DNA (the active agent in
REQORSA) encapsulated in non-viral nanoparticles that are
administered intravenously and designed to target tumor 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. The Company’s lead product
candidate, REQORSA™ (quaratusugene ozeplasmid), is being evaluated
as a treatment for non-small cell lung cancer (NSCLC). REQORSA 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. REQORSA 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
REQORSA 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 REQORSA™ immunogene therapy
drug, alone and in combination with targeted therapies and/or
immunotherapies, and whether our other potential product
candidates, including GPX-002, our gene therapy in diabetes,
advance into clinical trials; the success of our strategic
partnerships, including those relating to manufacturing of our
product candidates; the timing and success at all of obtaining any
FDA approvals of REQORSA and our other potential product candidates
including whether we receive or benefit from fast track or similar
regulatory designations; costs associated with developing our
product candidates, whether we identify and succeed in acquiring
other technologies and whether patents will ever be issued under
patent applications that are the subject of our license agreements
or otherwise. 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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