- Two
patients exceed 14 months on treatment in Phase 2 trial of advanced
ovarian cancer
- Allarity
maintains a cash balance of $18.5 million, sufficient to advance
and accelerate stenoparib’s clinical development toward FDA
approval
-
Expansion of Allarity Medical Laboratory into revenue-generating
services for external biotech clients
-
Continued focus on advancing stenoparib to address critical unmet
needs in ovarian cancer
Boston (November 18, 2024)—Allarity
Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a
Phase 2 clinical-stage pharmaceutical company dedicated to
developing personalized cancer treatments using its proprietary,
drug-specific patient selection technology, today provided a
corporate update highlighting three significant developments:
extended treatment duration for patients in its ongoing Phase 2
stenoparib trial, a strengthened cash position supporting
initiation of a follow-up FDA registrational trial, and new
revenue-generating activities from Allarity’s laboratory
services.
Key Progress in Phase 2 Stenoparib Trial Two
patients in Allarity’s Phase 2 clinical trial of stenoparib for
advanced, recurrent ovarian cancer have now been on treatment for
over 14 months, a remarkable duration of benefit given the heavily
pretreated status of these patients. This extended duration further
reinforces the potential of stenoparib as a promising treatment
option for advanced ovarian cancer patients who have already
undergone multiple lines of therapy, including prior PARP
inhibitors.
Strong Financial Position Supports Advancement of
Stenoparib ProgramWith a cash balance of $18.5 million as
of September 30, 2024, Allarity Therapeutics is well-positioned to
advance its clinical development programs. This solid financial
foundation enables the Company to confidently initiate the next
trial to advance stenoparib toward FDA registration.
Allarity Expands into Revenue-Generating Services for
External ClientsAllarity Therapeutics is also pleased to
announce that its in-house Allarity Medical Laboratory has expanded
from solely focusing on supporting internal drug development to
securing external service agreements, with multiple biotech
companies now leveraging the Company’s advanced gene expression and
diagnostic capabilities. This important expansion positions
Allarity Medical Laboratory as a direct provider of
revenue-generating, high-precision genomic services, establishing
it as a valuable complementary asset for the Company.
These service agreements include contracts for both Drug
Response Predictor (DRP®) analysis and comprehensive gene
expression services, reflecting Allarity’s leading technology and
ability to provide industry-leading insights to other innovators in
the biotech field. The revenue generated from such agreements
significantly reduce Allarity’s overall laboratory cost base while
advancing the position of Allarity’s proprietary DRP® platform
within the industry and supporting broader scientific advancements
in oncology.
Thomas Jensen, CEO of Allarity Therapeutics, commented, “Seeing
patients continue to benefit from stenoparib beyond 14 months is
very encouraging for us at Allarity, as it goes beyond our initial
hopes when we began the trial. We are pleased to see the lasting
clinical benefit in these very advanced patients and think this
reflects stenoparib’s unique therapeutic mechanism of action. We
are excited that our strengthened cash position now provides the
financial foundation to accelerate stenoparib’s clinical
development toward FDA approval”
He added, “I am also excited about our successful seamless
expansion into the service provider space. Over the years, our lab
team has developed deep expertise in advanced genetic analysis to
support cancer drug development, and naturally leveraging this to
build a revenue-generating analytics department is extremely
satisfying. In addition to generating meaningful revenue, this
expansion further establishes our company, our brand and the DRP®
platform within the oncology field.”
Background Information about the TrialThe
above-mentioned trial is a Phase 2, prospective open-label,
single-arm study with multiple sites in both the US and the UK.
Investigators prescreened women with advanced, recurrent ovarian
cancer using Allarity’s DRP® companion diagnostic (CDx), which
comprises a complex transcriptomic signature of 414 mRNA biomarkers
indicative of drug response or resistance. Each participant was
assigned a DRP score, and those with scores above 50 -suggesting a
higher likelihood of benefiting from treatment – were selected to
receive stenoparib. The selected patients were administered
stenoparib under a revised protocol implemented in Q1 2023, which
involved a twice-daily dosing regimen (200 mg in the morning and
400 mg in the evening) instead of the previous once-daily 600 mg
dose. This change was made to optimize daily drug exposure and
target inhibition.
The patients enrolled have advanced through multiple lines of
therapy, including platinum, taxanes, anti-angiogenesis inhibitors,
and even the recently approved Antibody Drug Conjugate, Elahere.
Importantly, most of the enrolled patients to date have been
previously treated with a PARP inhibitor. These patients have few,
if any, effective treatment options and typically advance through
available therapies after only a few months.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. Allarity has 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 proven its
ability to provide a statistically significant prediction of the
clinical outcome from drug treatment in cancer patients dozens of
clinical studies (both retrospective and prospective). The DRP
platform, which can be used 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® companion diagnostic for patient
selection in the ongoing phase 2 clinical trial, NCT03878849.
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, the potential impact of recent clinical,
financial, and operational achievements on future quarterly
performance, anticipated progress in regulatory milestones for
stenoparib, and potential revenue generation from external
laboratory services. 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 associated with securing regulatory approval for stenoparib,
achieving anticipated clinical trial results, and variability in
revenue from new laboratory services that could impact the
Company’s financial stability. 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 - Key Progress in Phase 2
Stenoparib Trial and Strategic Corporate Advancements
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