Third FDA Fast Track Designation Further
Validates the Potential of REQORSA
AUSTIN,
Texas, June 28, 2023 /PRNewswire/ -- 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, today announced that the
U.S. Food and Drug Administration (FDA) has granted Fast Track
Designation (FTD) for the Company's lead drug candidate, REQORSA®
Immunogene Therapy, in combination with Genentech, Inc.'s
Tecentriq® in patients with extensive-stage small cell lung cancer
(ES-SCLC) who did not develop tumor progression after receiving
Tecentriq and chemotherapy as initial standard treatment.
In the third quarter of 2023, Genprex expects to enroll the
first patient in its Acclaim-3 clinical trial, which is a Phase 1/2
dose escalation and clinical response study of maintenance therapy
evaluating REQORSA in combination with Tecentriq for this patient
population. The Company has previously received two other FTDs for
REQORSA, for REQORSA in combination with AstraZeneca PLC's
Tagrisso® in patients with late-stage non-small cell lung cancer
(NSCLC) whose disease progressed after treatment with Tagrisso, and
for REQORSA in combination with Merck & Co's Keytruda® in
patients with late-stage NSCLC whose disease progressed after
treatment with Keytruda.
"We are very pleased to receive a third Fast Track Designation
from the FDA for REQORSA, this time for patients with ES-SCLC in
combination with the checkpoint inhibitor Tecentriq," said
Rodney Varner, President, Chairman
and Chief Executive Officer at Genprex. "This is another exciting
achievement in our REQORSA development program, which further
validates REQORSA's potential not only in NSCLC but also in SCLC.
We look forward to accelerating the clinical development of
REQORSA, and potentially providing a new treatment option for
patients with SCLC."
Tumor suppressor genes are deleted or inactivated early in the
process of cancer development. REQORSA contains a plasmid that
expresses a tumor suppressor gene named TUSC2. Virtually 100% of
small cell lung cancers express decreased amounts of TUSC2 tumor
suppressor protein, and 41% completely lack TUSC2 protein
expression. ES-SCLC has a very poor prognosis, with a median
progression free survival (PFS) of only 5.2 months. Importantly,
median PFS for patients receiving Tecentriq as maintenance therapy
is only 2.6 months from the start of maintenance treatment, so
there is a great need for improvement in maintenance therapy.
"This Fast Track Designation for the Acclaim-3 patient
population is another validation of REQORSA's potential to treat
lung cancer," said Mark Berger, MD,
Chief Medical Officer at Genprex. "We are very excited to soon
begin treating patients in the Acclaim-3 clinical trial, which
positions REQORSA as a component of initial standard therapy for
SCLC rather than as treatment for relapse. That will allow us to
highlight the contribution of REQORSA to an earlier stage of
treatment. Based on our experience in other REQORSA trials, we have
reduced the Phase 1 portion of the study to two dose levels instead
of the three dose levels in our Acclaim-1 and Acclaim-2 clinical
trials. We believe this will shorten the Phase 1 portion of the
trial. In addition, the median PFS of only 2.6 months seen
with Tecentriq maintenance treatment will also shorten the time
needed to evaluate the combination of REQORSA and Tecentriq as
maintenance therapy for SCLC."
Patients in the Acclaim-3 clinical trial will be enrolled after
receiving initial treatment with 3-4 cycles of carboplatin,
etoposide, and Tecentriq, and achieving complete response, partial
response or stable disease. They will then receive treatment with
REQORSA and Tecentriq as maintenance therapy every 21 days until
disease progression.
The Phase 1 dose escalation portion of the Acclaim-3 clinical
trial is expected to enroll up to 12 patients at 3-5 U.S. clinical
sites to determine the Maximum Tolerated Dose (MTD). If no dose
limiting toxicities occur during Phase 1, then the highest dose
evaluated will be the Recommended Phase 2 Dose. The Phase 2 portion
of the study will then enroll approximately 50 patients at 5-10
sites. Patients will be treated with REQORSA and Tecentriq until
disease progression or unacceptable toxicity is experienced.
The primary endpoint of the Phase 2 portion of the trial is to
determine the 18-week progression-free survival rate from the time
of the start of maintenance therapy with REQORSA and Tecentriq in
patients with ES-SCLC. Patients will also be followed for survival.
A Phase 2 futility analysis will be performed after the
25th patient enrolled and treated reaches 18 weeks of
follow up.
FDA may award FTD if it determines that non-clinical or clinical
data demonstrate the potential for a drug to address an unmet
medical need for a serious or life-threatening disease or
condition. This provision is intended to facilitate development and
expedite review of such drugs so that a product, if approved, can
reach the market expeditiously.
FTD recipients may also be eligible for accelerated approval or
rolling review of the recipient's Biologics License Application
(BLA) if other qualifying criteria are met. In addition, Fast Track
product candidates could be eligible for priority review if
supported by clinical data at the time of BLA submission.
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. Genprex's oncology program
utilizes its proprietary, non-viral ONCOPREX® Nanoparticle Delivery
System which encapsulates the gene-expressing plasmids using lipid
nanoparticles. The resultant product is administered intravenously,
where it is taken up by tumor cells that then express tumor
suppressor proteins that were deficient in the tumor. The Company's
lead product candidate, REQORSA® (quaratusugene ozeplasmid),
is being evaluated in three clinical trials as a treatment for
non-small cell lung cancer (NSCLC) and small cell lung cancer
(SCLC). Both NSCLC clinical programs received a Fast Track
Designation from the Food and Drug Administration. Genprex's
diabetes gene therapy approach is comprised of a novel infusion
process that uses an adeno-associated virus (AAV) vector to deliver
Pdx1 and MafA genes directly to the pancreas. In models of Type 1
diabetes, GPX-002 transforms alpha cells in the pancreas into
functional beta-like cells, which can produce insulin but are
distinct enough from beta cells to evade the body's immune system.
In a similar approach, GPX-003 for Type 2 diabetes, where
autoimmunity is not at play, is believed to rejuvenate and
replenish exhausted beta cells.
Interested investors and shareholders are encouraged to sign up
for press releases and industry updates by visiting the Company
Website, registering for Email Alerts and by following 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 for the year ended
December 31, 2022.
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:
Genprex's ability to advance the clinical development,
manufacturing and commercialization of its product candidates in
accordance with projected timelines; 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, including Genprex's ability to continue to obtain
capital to meet its long-term liquidity needs on acceptable terms,
or at all; Genprex's commercial and strategic partnerships,
including those with its third party vendors, suppliers and
manufacturers and their ability to successfully perform and scale
up 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.
Genprex, Inc.
(877) 774-GNPX (4679)
GNPX Investor
Relations
investors@genprex.com
GNPX Media Contact
Kalyn
Dabbs
media@genprex.com
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SOURCE Genprex, Inc.