- The stenoparib Phase 2 monotherapy trial in advanced, recurrent
ovarian cancer continues to show promise, prompting shift in
resources to accelerate stenoparib development
- Further development of IXEMPRA® and dovitinib is
de-prioritized
- The Company has been able to reduce costs materially
Boston (March 27, 2024) — Allarity
Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a
clinical-stage pharmaceutical company dedicated to developing
personalized cancer treatments, today announced a strategic pivot
aimed at advancing its clinical-stage candidate stenoparib, a novel
PARP/Tankyrase dual inhibitor, toward registration in advanced
recurrent ovarian cancer, leveraging its DRP® platform to identify
and enroll only the patients most likely to derive clinical
benefit.
This decision is the outcome of an extensive analysis of the
Company’s strategic opportunities, initiated immediately after
Thomas Jensen stepped into his role as Interim CEO in early
December 2023. In partnership with Executive Advisor Jeremy R.
Graff, PhD and in agreement with the Board of Directors, this
analysis was meticulously carried out with a dual objective: to
rapidly channel the Company’s proprietary DRP® technology towards
benefiting a patient population with an unmet medical need while at
the same time taking the clinical risk/reward balance as well as
commercial and regulatory probabilities of success into
consideration.
This decisive shift in priorities is driven by the compelling
initial data from the Phase 2 monotherapy trial evaluating
stenoparib in advanced, recurrent ovarian cancer patients, as
announced on December 5, 2023.
For this trial, 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.
Emerging and maturing data continue to show that the clinical
benefit and duration on stenoparib are substantially exceeding
expectations:
- Clinical benefit has now exceeded 20 weeks for each of the five
patients originally mentioned in the December release, with the
first patient on trial remaining on treatment for more than ten
months.
- The Complete Responder, referenced in the December release, has
confirmed continued response through multiple additional scans and
remains on therapy.
- Durable clinical benefit is evident in patients with:
- Platinum-sensitive or resistant disease.
- Homologous repair proficient or deficient tumors; and
- both BRCA-wt or mutant cancers.
- These points highlight the differentiated mechanism of
therapeutic action for stenoparib and accentuate the benefit of
pre-selecting patients with DRP®.
These data have prompted the Company to funnel its finances and
internal resources to accelerate stenoparib development for this
advanced patient population.
Interim CEO of Allarity Thomas Jensen stated, “There remains a
clear unmet medical need in patients with advanced ovarian cancer
whose treatment options are limited to standard, older
chemotherapies that provide limited benefit and come with
significant toxicity. Based on the favorable tolerability with
stenoparib and the emerging clinical benefit evident in our
patients so far, we have decided to focus on re-tooling our company
to accelerate development of stenoparib toward registration as
quickly as possible for these desperately ill patients.”
As part of this strategic shift, the Company will deprioritize
the other clinical trials for dovitinib and IXEMPRA®.
An additional outcome of the strategic review is that Allarity
Therapeutics has been able to materially reduce its ongoing costs
and cash burn and still prioritize stenoparib to better align with
its new strategic priorities.
Several factors outside the Company have been included in the
above-mentioned analysis of the Company’s strategic opportunities.
This includes that the PARP inhibitor market, expected to reach $22
billion in revenue by 2028, has historically seen significant
partnerships and acquisitions. A recent notable example occurred
earlier this year with Merck KGaA’s agreement with Jiangsu Hengrui
Pharmaceuticals, involving an upfront payment of approx. $176
million for a PARP inhibitor (HRS-1167) and an antibody-drug
conjugate, potentially altogether totaling around $1.5 billion. In
terms of availability of treatments, 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. Extensive clinical experience with
stenoparib has continuously shown a favorable toxicity profile. In
addition, stenoparib is unique in its mechanism of action,
inhibiting PARP as well as the novel cancer target, tankyrase.
Tankyrase inhibition would restrain the WNT pathway, which is
commonly upregulated not only in ovarian cancers but in many other
solid cancers. Given the unique, dual mechanism of action for
stenoparib—coupled with its favorable safety profile—stenoparib may
represent the next-generation alternative in the evolving market
for advanced ovarian cancer patients.
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
Diagnostic Allarity uses its drug-specific DRP® to select
those patients who, by the 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 in 37 out
of 47 clinical studies that were examined (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 related to any statements related to
the de-prioritization of the other clinical trials for dovitinib
and IXEMPRA®, and any statements concerning an acceleration of the
stenoparib development. 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 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, the risk that the results of previously conducted
studies will not be repeated or observed in ongoing or future
studies involving our therapeutic candidates, and the risk that the
current COVID-19 pandemic will impact the Company’s current and
future clinical trials and the timing of the Company’s preclinical
studies and other operations. 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 - Strategic Pivot to Focus Solely on
Accelerating Stenoparib
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