Allarity Therapeutics to Begin Enrollment for New Phase 2 Protocol to Advance Stenoparib Toward FDA Approval in Advanced Ovarian Cancer Patients
24 2월 2025 - 10:00PM
- Patient
enrollment set to begin at leading U.S. clinical trial sites, new
drug product already delivered
- Trial
will advance stenoparib and the stenoparib-DRP Companion Diagnostic
toward FDA approval
- Two
patients in the ongoing phase 2 trial have now exceeded 17 months
on stenoparib treatment
Boston (February 24, 2025)—Allarity
Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a
Phase 2 clinical-stage pharmaceutical company dedicated to
developing stenoparib—a differentiated dual PARP/Wnt pathway
inhibitor—as a personalized cancer treatment using its proprietary,
drug-specific patient selection technology—the Drug Response
Predictor (DRP®)—today announced that the new protocol for its
Phase 2 clinical trial of stenoparib in ovarian cancer is set to
begin and will be expected to provide critical data by end of
summer 2026 for a pivotal registration trial.
The new protocol design was constructed following in-depth
review of the Company’s ongoing Phase 2 clinical data in
collaboration with key ovarian cancer thought leaders and treating
physicians, including the gynecologic oncologists who have been
treating patients with stenoparib in the ongoing phase 2 study.
This comprehensive review revealed compelling evidence for
stenoparib’s durable clinical benefit in platinum-resistant,
advanced ovarian cancer patients, including a complete, confirmed
response as well as two patients remaining on therapy without
progression for more than 17 months. The protocol reflects the
feedback of these gynecologic oncology experts as well as input
from the FDA. The protocol has now also been approved by the
Institutional Review Board of the first trial sites, paving the way
for the trial to begin patient enrollment immediately. Anticipating
IRB approval, to advance stenoparib, Allarity recently completed a
new drug manufacturing campaign and has readied finished drug
product for delivery to sites to expedite patient enrollment.
”The intensive review and finalization of this new protocol,
with feedback from the FDA, the IRB and our treating physicians
marks a critical milestone in our effort to accelerate stenoparib
as a potentially safer, more effective alternative to additional
lines of chemotherapy,” said Thomas Jensen, CEO of Allarity
Therapeutics. “Importantly, this new protocol simultaneously allows
us to accelerate the development of stenoparib alongside the
stenoparib-DRP as a companion diagnostic. Pushing both in parallel
will generate the critical data needed to support timely, connected
regulatory approval for both. We are very excited about the
thoughtful, unique design of this new protocol as it allows us to
quickly and effectively get stenoparib into the hands of the
world’s best gynecologic oncologists, benefiting patients who need
safer and more effective treatment options than the toxic
chemotherapy options they would otherwise have to rely upon. We are
particularly excited about the prospects of this trial advancing
stenoparib’s journey toward commercialization.”
This new protocol was designed expressly to enrich the
understanding of clinical benefit in a well-defined ovarian cancer
patient population with significant unmet medical need. In addition
to further deepening the clinical experience for stenoparib, this
trial will allow for the evaluation of the impact of stenoparib on
the Wnt pathway, a critical cellular signaling pathway implicated
in advanced ovarian cancer and multiple other malignancies,
including colon cancer. A deeper understanding of stenoparib’s role
in modulating the Wnt pathway would further differentiate
stenoparib in the $9B+ PARP inhibitor market. The ongoing Phase 2
study was the first stenoparib study to assess twice-daily dosing
and showed clear evidence for clinical benefit. The new protocol
will build upon this clinical experience with the current dose
while introducing an additional dose level to assess whether
clinical benefit can be further enhanced. Ultimately, this trial
will allow Allarity to address the FDA’s recent “Project Optimus”
guidelines and will set the stage for pivotal registration
studies.
Allarity expects to pursue multiple advantaged regulatory
pathways to expedite approval in the first half of 2025. Allarity
will also be presenting key data, with abstracts now accepted, at
multiple upcoming scientific and clinical conferences. Details will
be announced as embargo policies for these conferences allow.
About StenoparibStenoparib is an orally
available, small-molecule dual-targeted inhibitor of PARP1/2 and
tankyrase 1/2. At present, tankyrases are attracting significant
attention as emerging therapeutic targets for cancer, principally
due to their role in regulating the Wnt signaling pathway. Aberrant
Wnt/β-catenin signaling has been implicated in the development and
progression of numerous cancers. By inhibiting PARP and blocking
Wnt pathway activation, stenoparib’s unique therapeutic action
shows potential as a promising therapeutic for many cancer types,
including ovarian cancer. Allarity has secured exclusive global
rights for the development and commercialization of stenoparib,
which was originally developed by Eisai Co. Ltd. and was formerly
known under the names E7449 and 2X-121.About the Drug
Response Predictor – DRP® Companion DiagnosticAllarity
uses its drug-specific DRP® to select those patients who, by the
gene expression signature of their cancer, are found to have a high
likelihood of benefiting from a specific drug. By screening
patients before treatment, and only treating those patients with a
sufficiently high, drug-specific DRP score, the therapeutic benefit
rate may be significantly increased. The DRP method builds on the
comparison of sensitive vs. resistant human cancer cell lines,
including transcriptomic information from cell lines, combined with
clinical tumor biology filters and prior clinical trial outcomes.
DRP is based on messenger RNA expression profiles from patient
biopsies. The DRP® platform has shown an ability to provide a
statistically significant prediction of the clinical outcome from
drug treatment in cancer patients in dozens of clinical studies
(both retrospective and prospective). The DRP platform, which may
be useful in all cancer types and is patented for more than 70
anti-cancer drugs, has been extensively published in the
peer-reviewed literature.
About Allarity TherapeuticsAllarity
Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage
biopharmaceutical company dedicated to developing personalized
cancer treatments. The Company is focused on development of
stenoparib, a novel PARP/tankyrase inhibitor for advanced ovarian
cancer patients, using its DRP® technology to develop a companion
diagnostic that can be used to select those patients expected to
derive the greatest clinical benefit from stenoparib. Allarity is
headquartered in the U.S., with a research facility in Denmark, and
is committed to addressing significant unmet medical needs in
cancer treatment. For more information, visit www.allarity.com.
Follow Allarity on Social MediaLinkedIn:
https://www.linkedin.com/company/allaritytx/X:
https://twitter.com/allaritytx
Forward-Looking Statements This press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements provide the Company’s current expectations or forecasts
of future events. The words “anticipates,” “believe,” “continue,”
“could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,”
“possible,” “potential,” “predicts,” “project,” “should,” “would”
and similar expressions may identify forward-looking statements,
but the absence of these words does not mean that a statement is
not forward-looking. These forward-looking statements include, but
are not limited to, statements regarding the continued development
and regulatory progress of stenoparib, as well as plans to
implement a new clinical protocol, including collaboration with
leading U.S.clinical trial sites. Any forward-looking statements in
this press release are based on management’s current expectations
of future events and are subject to multiple risks and
uncertainties that could cause actual results to differ materially
and adversely from those set forth in or implied by such
forward-looking statements. These risks and uncertainties include,
but are not limited to, risks related to the successful execution
of clinical trials for stenoparib, securing regulatory approval,
and other operational and financial risks that could impact the
Company’s ability to achieve its goals. For a discussion of other
risks and uncertainties, and other important factors, any of which
could cause our actual results to differ from those contained in
the forward-looking statements, see the section entitled “Risk
Factors” in our Form S-1/A registration statement filed on April
17, 2024, our Form 10-K annual report on file with the Securities
and Exchange Commission (the “SEC”) and our Form 10-Q quarterly
report filed with the SEC on November 14, 2024, available at the
SEC’s website at www.sec.gov, and as well as discussions of
potential risks, uncertainties and other important factors in the
Company’s subsequent filings with the SEC. All information in this
press release is as of the date of the release, and the Company
undertakes no duty to update this information unless required by
law.
###
Company Contact:
investorrelations@allarity.com
Media
Contact: Thomas
Pedersen Carrotize
PR &
Communications +45
6062 9390 tsp@carrotize.com
- Allarity Therapeutics Press Release - Allarity to Begin
Enrollment for New Phase 2 Protocol
Allarity Therapeutics (NASDAQ:ALLR)
과거 데이터 주식 차트
부터 1월(1) 2025 으로 2월(2) 2025
Allarity Therapeutics (NASDAQ:ALLR)
과거 데이터 주식 차트
부터 2월(2) 2024 으로 2월(2) 2025
