Genprex Initiates Site Recruitment for Acclaim-2 Clinical Trial for the Treatment of Non-Small Cell Lung Cancer
May 04 2021 - 9:32AM
Business Wire
Acclaim-2 Clinical Trial Combines REQORSA™
immunogene therapy with Merck & Co’s Keytruda®
Company Expects to Recruit Approximately 15
Sites Across the United States
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, is
pleased to announce it has commenced clinical trial site
recruitment for its upcoming Acclaim-2 clinical trial for the
treatment of non-small cell lung cancer (NSCLC).
Acclaim-2 is an open-label, multi-center Phase 1/2 clinical
trial that combines Genprex’s lead drug candidate, REQORSA™
immunogene therapy, with Merck & Co, Inc’s Keytruda in patients
with late-stage NSCLC who are low expressors (1% to 49%) of the
protein programmed death-ligand 1 ("PD-L1").
“Our clinical team remains focused on engaging with leading
clinical investigators and esteemed research institutions in order
to further our mission of bringing hope to lung cancer patients who
are in need of new treatment options,” said Rodney Varner,
President and Chief Executive Officer of Genprex. “We look forward
to selecting the most optimal study sites, which will help to
further fuel the success of our clinical trials.”
The Company plans to conduct the Acclaim-2 clinical trial in
approximately 15 sites with about 150 patients in an adaptive Phase
1/2 design. The final protocol is subject to change based on input
from investigators.
Additional information on the Acclaim-2 clinical trial will be
posted on ClinicalTrials.gov.
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
AstraZeneca’s Tagrisso® (osimertinib) for patients with EFGR
mutations whose tumors progressed after treatment with
Tagrisso.
For more information, please visit the Company’s web site at
www.genprex.com or follow Genprex on Twitter, Facebook and
LinkedIn.
Cautionary Language Concerning 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. These forward-looking statements are made on the basis of
the current beliefs, expectations and assumptions of management,
are not guarantees of performance and are subject to significant
risks and uncertainty. These forward-looking statements should,
therefore, be considered in light of various important factors,
including those set forth in Genprex’s reports that it files from
time to time with the Securities and Exchange Commission and which
you should review, including those statements under “Item 1A – Risk
Factors” in Genprex’s Annual Report on Form 10-K.
Because forward-looking 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 timing and success of Genprex’s clinical trials and regulatory
approvals; the effect of Genprex’s product candidates, alone and in
combination with other therapies, on cancer and diabetes; Genprex’s
future growth and financial status; Genprex’s commercial and
strategic partnerships including the scale up of the manufacture of
its product candidates; and Genprex’s intellectual property and
licenses.
These forward-looking statements should not be relied upon as
predictions of future events and Genprex cannot assure you that the
events or circumstances discussed or reflected in these statements
will be achieved or will occur. If such forward-looking statements
prove to be inaccurate, the inaccuracy may be material. You should
not regard these statements as a representation or warranty by
Genprex or any other person that Genprex will achieve its
objectives and plans in any specified timeframe, or at all. You are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this press release.
Genprex disclaims any obligation to publicly update or release any
revisions to these forward-looking statements, whether as a result
of new information, future events or otherwise, after the date of
this press release or to reflect the occurrence of unanticipated
events, except as required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210504005405/en/
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
Genprex (NASDAQ:GNPX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Genprex (NASDAQ:GNPX)
Historical Stock Chart
From Sep 2023 to Sep 2024