Genprex Achieves Major Manufacturing Milestone for REQORSA™ Immunogene Therapy for Upcoming Trials to Treat Non-Small Cell ...
January 13 2021 - 9:00AM
Business Wire
Company passes final release tests of scaled-up
clinical grade production to supply drug product for upcoming
Acclaim-1 and Acclaim-2 clinical trials in lung cancer
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 met all specifications and passed all
of the final release tests for its first scaled-up clinical-grade
manufacturing run of REQORSA™ immunogene therapy, in advance of its
upcoming Acclaim-1 and Acclaim-2 clinical trials for the treatment
of non-small cell lung cancer (NSCLC).
“The successful completion of this final step in our scaled-up
clinical grade manufacturing of REQORSA marks a key manufacturing
milestone for Genprex, and is credited to the hard work and
commitment of both our internal manufacturing group and our
manufacturing partners,” said Rodney Varner, President and Chief
Executive Officer of Genprex. “This production provides supply of
REQORSA for our two upcoming Acclaim clinical trials and advances
our mission to develop innovative new treatments for non-small cell
lung cancer patients greatly in need of effective therapy
options.”
Genprex recently announced the successful completion of the
technology transfer of its manufacturing process for the production
of REQORSA from the major research institution where it was
previously manufactured to experienced commercial Contract
Development and Manufacturing Organizations (CDMOs). The Company
also reported the completion of the manufacturing scale-up for the
clinical-grade production of REQORSA, subject to final testing that
was underway. Passing all lot release specifications marks the
successful completion of Genprex’ manufacture of REQORSA 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.
Clinical-grade REQORSA has been shipped and delivered to its
first cold storage depot. From there, REQORSA supply will be
delivered to the clinical trial sites pending FDA clearance to
commence the clinical trials. This production run 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.
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, 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 necessary approvals
to commence clinical trials 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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