Full Press Release Details
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:
Therapeutics, Inc. I 24 School Street, 2nd Floor I Boston, MA I U.S.A.
I NASDAQ: ALLR I www.allarity.com
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
"We are enthusiastic about these early, promising
data since the observed clinical benefit indicates that stenoparib is active in 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.
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/ -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.
Therapeutics, Inc. I 24 School Street, 2nd Floor I Boston, MA I U.S.A.
I NASDAQ: ALLR I www.allarity.com
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
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.
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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 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