- All
evaluable participants, with prior PARP inhibitor therapy and
chemotherapy, showed significant tumor shrinkage including one
complete response
-
Early data follows Phase 2 dose optimization change from once-daily
to twice-daily
Boston (December 5, 2023) — Allarity
Therapeutics, Inc. (“Allarity” or the “Company”) (Nasdaq: ALLR), a
clinical-stage pharmaceutical company developing novel oncology
therapeutics together with drug-specific DRP® companion diagnostics
for personalized cancer care, today announced encouraging initial
results from its ongoing Phase 2 clinical trial evaluating the
efficacy of its PARP inhibitor, stenoparib, in women with advanced
ovarian cancer (AOC). Of the five evaluable patients included in
the initial data analysis, one patient experienced a complete
response and the other four demonstrated stable disease.
Investigators prescreened women with AOC using Allarity’s
DRP®-Stenoparib CDx, a complex transcriptomic signature
comprising 414 mRNA biomarkers indicative of response/resistance to
the drug. Each woman was assigned a DRP®-score, and those with
scores above 50%, which suggested a higher likelihood of benefiting
from treatment with stenoparib, were selected for treatment.
Selected patients received stenoparib in a twice daily (BID) dosing
regimen (200 mg morning, 400 mg evening) under a change in
protocol, implemented earlier in the year, from prior once-daily
dosing of 600 mg. Allarity implemented the protocol change to
optimize the drug exposure taking into account the half-life of
stenoparib in patients.
Of the 22 patients screened with the DRP®-Stenoparib CDx,
17 DRP® positive patients were identified. Eleven women have
entered treatment, and among the five evaluable participants
assessed up to the data evaluation cut-off, there were early signs
of clinical benefit in all cases:
- One patient experienced a complete response (CR) by scan (to be
confirmed by second scan) and by decreased levels of CA125 (a
biomarker of AOC).
- One patient experienced stable disease with tumor shrinkage of
19%.
- One patient experienced stable disease for more than 24 weeks
with tumor shrinkage of 11%.
- Two patients experienced stable disease with tumor shrinkage of
8%.
All five patients had previously been treated with another PARP
inhibitor. All five patients remain in treatment with stenoparib
and the four that did not have complete responses are showing
stable disease at this time.
“We are enthusiastic about these early, promising data
since the observed clinical benefit indicates
that stenoparib is active in advanced ovarian cancer patients
selected with the DRP® -Stenoparib CDx, even though these
women had prior PARP inhibitor therapy and chemotherapy. While
still early, these data suggest that BID dosing of this drug,
and the use of the DRP® -Stenoparib CDx for patient
selection and treatment, may provide advanced ovarian cancer
patients meaningful benefit. The DRP® -Stenoparib CDx, if
approved, may provide clinicians with an
important diagnostic to guide
patient treatment in this hard-to-treat patient
population," said Marie Foegh, M.D., Chief Medical Officer of
Allarity.
The initial data readout is from an ongoing Phase 2 open-label,
single-arm trial that Allarity is conducting at multiple sites in
the U.S. and Europe. The goal of the study is to evaluate the
anti-tumor effect of stenoparib as monotherapy in
DRP®-selected patients with locally recurrent or metastatic ovarian
cancer after previous PARP inhibitor and chemotherapy treatments.
The primary endpoint is objective response rate (ORR). Allarity
anticipates an interim data readout in Q1 2024.
The DRP®-Stenoparib CDx is a transcriptomic signature comprising
414 mRNA biomarkers that are collectively predictive of tumor
sensitivity or resistance to stenoparib. Using the
DRP® CDx to select likely responder patients while excluding
likely resistant ones, Allarity aims to improve the benefit-risk
ratio of stenoparib in metastatic or locally advanced ovarian
cancer. The initial data from Allarity’s ongoing DRP®-guided Phase
2 study of stenoparib suggests that the
DRP®-Stenoparib CDx may identify a subset of AOC patients
previously treated with a PARP inhibitor who may benefit from
treatment with stenoparib. The DRP®-Stenoparib CDx is a
clinical-stage companion diagnostic candidate and has not yet been
approved by the U.S. FDA or the EU’s EMA.
All preliminary data are subject to change until the final study
data readout. Early trial results may not be a reliable indicator
of subsequent trial results based on a larger patient
population.
About Stenoparib
Stenoparib is an orally-available, small molecule dual-targeted
inhibitor of PARP1/2 and telomerase maintenance enzymes (Tankyrase
1 and 2). At present, tankyrases are attracting significant
attention as emerging therapeutic targets for cancer, principally
due to their role in the Wnt signaling pathway. Aberrant
Wnt/β-catenin signaling has been implicated in the development and
progression of multiple cancers, potentially giving stenoparib a
unique, dual tumor inhibitory action. Stenoparib was
originally developed by Eisai Co. Ltd. and was formerly known under
the names E7449 and 2X-121. Allarity has the exclusive, global
rights for the development and commercialization of
stenoparib.
Some approved PARP inhibitors have recently been shown to be
associated with less favorable survival outcomes than initially
established. Allarity’s Phase 2 trial data for stenoparib to date
shows that the drug has much less myelotoxicity than the FDA
approved PARP inhibitors. Specifically, in 42 evaluable women in
Phase 2 studies with stenoparib, anemia (21%), neutropenia (2%) and
thrombocytopenia (0%) was lower than the approved PARP inhibitor
niraparib with anemia 51%, neutropenia in 20% and thrombocytopenia
oberved in in 52% of 463 patients. Allarity anticipates that this
lower myelotoxicity may make stenoparib a better candidate for
combination with other drugs. Allarity is studying the therapeutic
potential of stenoparib in combination with dovitinib (a
pan-targeted kinase inhibitor) in an ongoing Phase 1b trial, with
an anticipated data readout near early Q2 2024. The Company
believes that stenoparib may have broad therapeutic potential in
combination with other anti-tumor agents.
About Allarity
Therapeutics Allarity Therapeutics,
Inc. (Nasdaq: ALLR) develops drugs for personalized treatment of
cancer guided by its proprietary and highly validated companion
diagnostic technology, the DRP® platform. The Company has a
mature portfolio of three drug candidates: stenoparib, a PARP
inhibitor in Phase 2 development for ovarian cancer, and in Phase 1
development for advanced solid tumors in a combination treatment
with dovitinib, a pan-tyrosine kinase inhibitor (pan-TKI) that has
previously been developed through Phase 3 in renal cancer; and
IXEMPRA® (Ixabepilone), a microtubule inhibitor approved in
the U.S. and marketed by R-PHARM U.S. for the treatment of
second-line metastatic breast cancer, currently in Phase 2
development in Europe for the same indication. Additionally, the
Company has rights in two secondary assets: 2X-111, a liposomal
formulation of doxorubicin for metastatic breast cancer and/or
glioblastoma multiforme (GBM), which is the subject of discussions
for a restructured out-license to Smerud Medical Research
International AS; and LiPlaCis®, a liposomal formulation of
cisplatin and its accompanying DRP®, being developed via a
partnership with CHOSA Oncology AB for late-stage metastatic breast
cancer. The Company is headquartered in the United States and
maintains an R&D facility in Hoersholm, Denmark. For more
information, please visit the Company’s website
at www.Allarity.com.
About the Drug Response Predictor –
DRP® Companion
Diagnostic Allarity uses its
drug-specific DRP® to select those patients who, by the genetic
signature of their cancer, are found to have a high likelihood of
responding to the specific drug. By screening patients before
treatment, and only treating those patients with a sufficiently
high DRP® score, the therapeutic response rate can 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 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), including ongoing, prospective Phase 2 trials of
Stenoparib and IXEMPRA®. 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 peer-reviewed
literature.
Follow Allarity
on Social Media
LinkedIn: https://www.linkedin.com/company/allaritytx/
Twitter: 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 Allarity’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 the expected availability
of capital to fund its anticipated clinical trials, statements
related to advancing dovitinib in combination with stenoparib or
another therapeutic candidate or other approved drug, any
statements related to ongoing clinical trials for stenoparib as a
monotherapy or in combination with another therapeutic candidate
for the treatment of advanced ovarian cancer, or ongoing clinical
trials (in Europe) for IXEMPRA® for the treatment of
metastatic breast cancer, statements relating to the effectiveness
of the Company’s DRP® companion diagnostics platform in
predicting whether a particular patient is likely to respond to a
specific drug, and statements related to the Company’s ability to
regain compliance with the Nasdaq Listing Rule. 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, dovitinib 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, available at the Securities and Exchange Commission’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 Securities and
Exchange Commission. 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
U.S. Media
Contact: Mike
Beyer Sam Brown,
Inc. +1 (312)
961-2502
mikebeyer@sambrown.com EU
Media
Contact: Thomas
Pedersen Carrotize
PR &
Communications +45
6062 9390 tsp@carrotize.com
- Allarity Therapeutics - Press Release Initial Stenoparib
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