Genprex Enters Into Exclusive Worldwide Patent & Technology License Agreement for Combination of its TUSC2 Gene Therapy with ...
May 05 2020 - 8:17AM
Business Wire
New license agreement expands Genprex’s
oncology franchise
Licensed technologies include use of Genprex’s
TUSC2 gene therapy combined with immunotherapy drugs,
including:
- Pembrolizumab (Merck’s largest selling drug Keytruda®)
- Nivolumab (Bristol-Myers Squibb’s Opdivo®)
- Ipilimumab (Bristol-Myers Squibb’s Yervoy®)
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,
today announced that it has entered into a Patent and Technology
License Agreement (“License Agreement”) with The University of
Texas MD Anderson Cancer Center (“MD Anderson”) in which MD
Anderson granted to Genprex an exclusive worldwide license to a
portfolio of 16 patent applications and related technology
(“Licensed IP”) for the treatment of cancer using Genprex’s lead
drug candidate and TUSC2 gene therapy, known as “Oncoprex” or
“GEN-001,” in combination with immunotherapies. This is a distinct
therapeutic approach from that of combining Oncoprex with targeted
therapies such as osimertinib (marketed as Tagrisso® by
AstraZeneca).
Genprex was recently awarded U.S. FDA Fast Track designation for
use of Oncoprex combined with Tagrisso for the treatment of
non-small cell lung cancer (NSCLC) patients with EGFR mutations
whose tumors progressed after treatment with Tagrisso alone. The
Company is now preparing to file an Investigational New Drug
application to initiate a clinical trial of Oncoprex in combination
with pembrolizumab (marketed as Keytruda® by Merck) in NSCLC.
“We are pleased to advance the intellectual property that is
covered by this License Agreement,” said Rodney Varner, Genprex’s
Chairman and Chief Executive Officer. “We are excited to be
developing two distinct therapeutic approaches to lung cancer
utilizing the combination of our gene therapy with successful
targeted therapies, such as Tagrisso, and immunotherapies, such as
Keytruda, to potentially improve patient outcomes and increase the
number of patients who may benefit from these important
therapies.”
Immunotherapy or immunotherapy combined with chemotherapy is now
the first-line standard of care for the majority of lung cancer
patients. Published preclinical data indicate that when Oncoprex is
combined with immunotherapies such as Keytruda, Oncoprex is
synergistic with those drugs, meaning that the combination is more
effective than either drug alone. The combination of Oncoprex and
Keytruda may lead to better outcomes for many lung cancer
patients.
The Licensed IP covers the use of Oncoprex in combination with
one or more immunotherapies, including anti-PD1 antibodies,
anti-PDL1 antibodies, anti-PDL2 antibodies, anti-CTLA-4 antibodies
and/or anti-KIR antibodies for the treatment of cancer. These
immunotherapies include pembrolizumab (Merck’s largest selling drug
Keytruda), nivolumab (Bristol-Myers Squibb’s Opdivo), ipilimumab
(Bristol-Myers Squibb’s Yervoy), and others. Use of chemotherapy in
combination with Oncoprex and immunotherapy is also covered by the
Licensed IP. While the initial disease indication for Oncoprex is
NSCLC, the Licensed IP claims patent protection for combination use
of Oncoprex in all types of cancers.
The License Agreement also provides for payment to MD Anderson
of an up-front license fee and annual maintenance fees, with the
potential for milestone payments, sublicensing fees, and product
royalties.
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 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 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; 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; 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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