- Durable Clinical Benefit Observed Beyond a Year
on Treatment in Heavily Pre-Treated Patients
Boston (September 16, 2024) — Allarity
Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a
clinical-stage pharmaceutical company dedicated to developing
personalized cancer treatments, today announced that two patients
enrolled in its Phase 2 clinical trial of stenoparib for advanced,
recurrent ovarian cancer have now exceeded one year on therapy.
The patients had been pre-screened using Allarity’s Drug
Response Predictor (DRP®) companion diagnostic, which identified
them as having a high likelihood of benefiting from stenoparib, the
Company’s novel dual PARP/Tankyrase inhibitor.
This remarkably lengthy treatment period highlights the
potential of stenoparib to provide durable clinical benefit, even
in heavily pre-treated ovarian cancer patients who have limited
treatment options. The trial continues to evaluate stenoparib’s
safety and efficacy, showing a confirmed, complete response as well
as long term disease stability for multiple patients.
Thomas Jensen, CEO of Allarity Therapeutics, commented on this
clinical achievement:
“We are incredibly encouraged by the sustained clinical benefit
seen in these patients, who have now been on stenoparib for over a
year. For heavily pre-treated ovarian cancer patients, extending
life by 52 weeks is particularly noteworthy. Stenoparib’s unique
mechanism of action, as both a PARP and Tankyrase inhibitor, sets
it apart from other treatments. These results reinforce our belief
in stenoparib’s potential as an important new therapy for ovarian
cancer patients who have exhausted other treatment options.”
Dr. Fernanda B. Musa, Director of Clinical Research in
Gynecology Oncology and site Principal Investigator at the Swedish
Cancer Institute for the trial added:
“We have been surprised and excited to see a long duration of
response to a single-agent oral therapy in patients with ovarian
cancer who had failed multiple other types of treatment. I credit
the success to personalized medicine: the pairing of the therapy to
the patient’s specific tumor profile. I look forward to seeing
further development of this program!”
Allarity is actively planning the further advancement of its
stenoparib program, with a focus on accelerating its path toward
regulatory approval. The Company remains dedicated to exploring
stenoparib’s long-term clinical benefit in DRP®-selected patients
and is preparing for the next phase of development. Additional
updates on the program’s progress and future trials will be shared
in the coming months.
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 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, statements regarding the clinical progress of
stenoparib, including the long-term benefit observed in patients,
and the Company's plans to advance stenoparib toward regulatory
approval]. 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, Allarity’s ability
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, 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 October
30, 2023, as amended 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 - Two Patients Now
Exceeding One Year of Treatment with Stenoparib
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