Boston (February 6, 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 plans for the next step in
advancing the clinical development of stenoparib toward FDA
approval in advanced ovarian cancer. With this new phase 2
protocol, Allarity will capitalize and expand on the ongoing phase
2 clinical trial data to optimize the dose of stenoparib and to
refine the DRP® patient selection criteria in order to maximize the
clinical benefit from stenoparib.
An in-depth review of Allarity’s maturing clinical data, in
collaboration with leading clinical investigators, prompted
Allarity to design this new Phase 2 protocol to enable a more
aggressive push of stenoparib toward regulatory approval. The
protocol will enable new enrollment expressly focusing on patients
with advanced, recurrent, platinum-resistant disease, a group that
has shown durable clinical benefit from stenoparib in the current
phase 2 trial and who have only limited treatment options following
standard chemotherapy. In addition to expanding and deepening the
clinical data set necessary for regulatory approval, this trial is
also designed to enhance the understanding of stenoparib’s unique
therapeutic mechanism of action. Of particular interest will be the
impact of stenoparib treatment on the Wnt pathway, a key cellular
pathway repeatedly shown to be involved in advanced ovarian cancers
as well as many other advanced cancer types, most notably colon
cancers. A richer understanding of stenoparib’s potential for
controlling the Wnt pathway—a key aspect of the newly designed
trial—could further distinguish stenoparib as a unique
investigational cancer treatment.
The protocol will also further refine Allarity’s understanding
of the stenoparib-DRP® for identifying patients most likely to
benefit from stenoparib treatment. As part of the trial, a DRP
score will be assessed for all enrolled patients to generate the
deeper, more robust data set necessary to refine the DRP cut-off
that would ring-fence patients most likely to benefit from
stenoparib. These data will be fundamental for supporting any
regulatory approval for the stenoparib-DRP as a companion
diagnostic (CDx) specific to stenoparib.
The Company has previously announced long-lasting clinical
benefit for advanced, recurrent ovarian cancer patients, with some
of these patients continuing on therapy for more than 14 months.
Based upon these encouraging clinical benefit data, Allarity
intends to pursue an advantaged regulatory path toward approval to
further enable stenoparib’s clinical development.
Patient enrollment is expected to begin in the first half of
2025, subject to final protocol review by regulatory authorities.
Recruitment will commence at leading U.S. trial sites, with the
potential inclusion of additional sites in the U.K. as
warranted.
“Until now, patients receiving stenoparib have had diverse and
often extensive treatment histories, with many being very heavily
pretreated. Based on data we have gathered to date from our
clinical trials, and through in-depth analysis and consultation
with leading gynecologic oncologists, we have developed a new
clinical trial protocol focused on a well-defined, commercially
significant patient population in desperate need of newer, safer
treatment options beyond more chemotherapy, which comes with
well-documented side effects,” said Thomas Jensen, CEO of Allarity
Therapeutics. “We are therefore pleased to have submitted this
trial design and are eager to begin patient enrollment as soon as
we receive the final green light from the regulatory authorities,
including the FDA.”
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 selelct 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. 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 - Expansion of Phase 2
Clinical Trial to Accelerate Development of Stenoparib
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