Full Press Release Details
Allarity Therapeutics' Dual PARP/Tankyrase
Stenoparib, Continues to Show Extended Clinical Benefit in Advanced Ovarian Cancer
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.
Allarity Therapeutics, Inc. I 24 School Street, 2nd Floor I Boston, MA I U.S.A. I NASDAQ: ALLR I www.allarity.com
Background Information about the Trial
The 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.
Stenoparib 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/ -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
Allarity 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 Therapeutics
Allarity 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.
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Allarity Therapeutics, Inc. I 24 School Street, 2nd Floor I Boston, MA I U.S.A. I NASDAQ: ALLR I www.allarity.com
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