Genprex Completes Manufacturing Technology Transfer for Novel Gene Therapy
December 08 2020 - 8:16AM
Business Wire
Successful Completion of Engineering Batch with
Transfer from Research Institution to Commercial Contract
Development and Manufacturing Organizations with Clinical
Production Underway
Manufacturing Technology Transfer Marks Major
Company Milestone
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 successfully completed the technology
transfer of its manufacturing process for the production of
REQORSA™ immunogene therapy, the Company’s lead drug candidate,
from the major cancer research institution where it was previously
manufactured to experienced, commercial Contract Development and
Manufacturing Organizations (CDMOs).
The completed technology transfer marks a significant
achievement for Genprex. For the first time, REQORSA was
manufactured at commercial scale in a current Good Manufacturing
Practices (cGMP) compliant facility, outside of the research
institution where REQORSA was discovered. The Company believes
production and process improvements will result in a reliable,
scalable, reproducible and stable drug product suitable for
storage, shipment and patient use. The Company believes that it is
on track to complete manufacturing of clinical grade REQORSA to
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 2021.
“The successful completion of our manufacturing technology
transfer represents a major milestone for Genprex,” said Rodney
Varner, President and Chief Executive Officer of Genprex. “We are
delighted to collaborate with leading, global CDMOs that have
enabled us to complete the successful engineering batch. We are now
focused on the completion of commercial scale production of
REQORSA, for use in our two upcoming clinical trials. At the same
time, our clinical group is engaging with clinical trial sites who
will recruit and treat patients related to our clinical
trials.”
All components of the manufacturing processes, including the
final drug product, have been manufactured at commercial CDMOs.
Furthermore, Genprex’s engineering run met all specifications.
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.
Earlier this year, Genprex announced an agreement with Aldevron,
LLC to manufacture the TUSC2 plasmid DNA used in REQORSA.
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 FDA approval 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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