- Multiple
patients have now exceeded 30 weeks on treatment
Boston (June 25, 2024)—Allarity Therapeutics,
Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2
clinical-stage pharmaceutical company dedicated to developing
personalized cancer treatments, today announced that multiple
patients in its Phase 2 clinical trial of stenoparib for advanced
recurrent ovarian cancer have been on treatment for more than 30
weeks.
The continued durability of clinical benefit further bolsters
the Company’s announcement in early May 2024 that stenoparib had
shown clear clinical benefit, including significant tumor shrinkage
and long-term disease stability, in patients who had been heavily
pre-treated for their ovarian cancer and otherwise have limited
life expectancy. These results provided clinical proof of concept
for stenoparib as a treatment in this patient population, prompting
the company to halt patient enrollment to focus its resources on
developing a follow-on trial designed to accelerate the path for
stenoparib toward regulatory approval.
Kathleen N. Moore, MD, MS, Deputy Director of the Stephenson
Cancer Center, Professor of the Section of Gynecologic Oncology and
the Virginia Kerley Cade Chair in Developmental Therapeutics,
serves as the Principal Investigator for the current Allarity
trial: “Inhibition of poly-ADP-ribose polymerase or PARP has been
transformational for the treatment of ovarian cancer with
first-generation agents significantly improving progression-free
and overall survival especially among patients with biomarkers for
their use. However, there are a significant number of patients who
either don’t benefit at all from inhibition of PARP or only
modestly and for them, continual development of next-generation
agents remains a high priority. The promising results observed with
stenoparib - particularly with the tolerability demonstrated so
far, warrant further development of this drug. I look forward to
continuing the discussions with the team at Allarity to refine the
future trial design and subsequently continue to investigate the
potential of this novel PARP/Tankyrase inhibitor.”
"The continued durability of clinical benefit from stenoparib
furthers our enthusiasm for stenoparib for patients who
traditionally have limited treatment options and often only a few
months of continued life expectancy. We continue to see patients
maintain their quality of life with minimal side effects for
extended periods,” stated Allarity Therapeutics CEO Thomas Jensen.
He elaborated, “Not only does the safety profile stand out when
compared to chemotherapies, which is often the alternative for this
patient group, but the safety metrics are indeed also favorable
when compared to first-generation PARP inhibitors. As we see it,
stenoparib may represent the next-generation alternative for
advanced ovarian cancer patients. Therefore, we are aggressively
working with Dr. Moore and other leading experts to design a trial
that will help advance and quicken stenoparib’s clinical progress
toward registration with the FDA.”
After conducting a detailed review of the stenoparib monotherapy
trial data, including the data announced today, the Company has
concluded that these data may be of significant interest among key
oncologists, potential commercial partners, and other relevant
stakeholders and therefore warrant presentation within a high-level
scientific conference. Further release of these clinical data is
intended to be staged to comply with the common rules of scientific
conferences, which do not allow data to be published before the
event.
The PARP inhibitor market saw a major shift in 2022 as
rucaparib, olaparib, and niraparib were withdrawn for heavily
pretreated ovarian cancer patients, underscoring the need for new,
effective PARP inhibitors with a more favorable safety profile. The
PARP inhibitor market is expected to reach $22 billion in revenue
by 2028, and has historically seen significant partnerships and
acquisitions. Recent interest in the market has focused on the
development of PARP inhibitors with improved tolerability and
safety profiles, leading to notable activity in the sector. For
example, one significant acquisition included a multi-asset deal
potentially totaling $1.5 billion, which featured an advanced PARP
inhibitor. Stenoparib is orally available and also shares an
advantaged safety profile relative to 1st generation PARP
inhibitors. It also inhibits the Tankyrase 1 and 2 enzymes, which
helps block the activity of the WNT/Beta-catenin pathway, a pathway
often overactive in ovarian and many other solid cancers. The
safety and unique, dual inhibitory activities of stenoparib make it
a differentiated and compelling potential therapeutic product.
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, all but two 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 and 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 impact of recent clinical and operational
achievements on future trial designs, potential commercial
partnerships, planning and carrying out registrational intent
clinical trials, the anticipated regulatory progress of stenoparib
following the early conclusion of our Phase 2 clinical trial, and
the possibility that there may not be any presentation at a
scientific event. 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, the
risks associated with maintaining compliance with Nasdaq's
continued listing requirements, the trading price of Allarity’s
shares of common stock may be volatile and other risks inherent in
Allarity’s business, including, the risk that the Company is not
able to raise sufficient capital to support its current and
anticipated clinical trials, the risk that early results of a
clinical study do not necessarily predict final results and that
one or more of the clinical outcomes may materially change
following more comprehensive reviews of the data, and as more
patient data become available, the risk that results of a clinical
study are subject to interpretation and additional analyses may be
needed and/or may contradict such results, the receipt of
regulatory approval for stenoparib or any of our other therapeutic
candidates and companion diagnostics or, if approved, the
successful commercialization of such products, the risk of
cessation or delay of any of the ongoing or planned clinical trials
and/or our development of our product candidates, and the risk that
the results of previously conducted studies will not be repeated or
observed in ongoing or future studies involving our therapeutic
candidates. 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
registration statement filed on April 17, 2024, and our Form 10-K
annual report on file with the Securities and Exchange Commission
(the “SEC”), 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 - Stenoparib Continues to
Show Extended Clinical Benefit in AOC
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