Full Press Release Details
Allarity Therapeutics Provides Updates for IXEMPRA
and Stenoparib Phase 2 Monotherapy Clinical Studies
Efforts underway to accelerate patient recruitment
to improve patient outcomes.
Interim data readouts for both studies anticipated
BOSTON - March 28, 2023 -
Allarity Therapeutics, Inc. (NASDAQ: ALLR) ("Allarity" or "the Company"), a clinical-stage pharmaceutical
company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized
cancer care, today announced updates to its ongoing phase 2 clinical programs evaluating IXEMPRA and stenoparib as monotherapies.
For both IXEMPRA and stenoparib monotherapy trials,
Allarity is taking steps to accelerate patient recruitment to support the goals for interim data readouts by the end of 2023. Due to slower
than anticipated patient enrollment in both studies, owing in part to impacts of the COVID pandemic on trial site staffing, Allarity has
expanded its collaboration with multiple contract research organizations (CROs) to substantially increase the number of active trial sites.
The Company has also made changes to the clinical trial protocols to increase the availability of eligible participants for both monotherapy
"Patient recruitment in oncology clinical
trials is an ongoing challenge and has delayed target date readouts across our sector. I am optimistic that our ongoing efforts to address
this challenge will make a positive impact on our goal of providing interim data readouts in our ongoing Phase 2 studies by year's
end," said James G. Cullem, Chief Executive Officer of Allarity Therapeutics. "Similarly, our trial protocol amendments
reflect Allarity's adaptability and commitment to seek optimal patient benefit in our clinical studies, guided by our unique DRP
companion diagnostics, to select and treat most likely-to-respond patients."
Allarity is sponsoring an ongoing DRP-guided Phase
2 clinical trial evaluating IXEMPRA as a monotherapy in metastatic breast cancer in Europe. In addition to expanding its CRO partnerships,
Allarity has implemented a trial protocol amendment that will lower the IXEMPRA-DRP companion diagnostic cut-off score, for enrollment,
from 67% to 33%. As a result, Allarity anticipates that it will have sufficient DRP-positive patient enrollment to support an interim
data readout from this study in late 2023.
The Company is also evaluating stenoparib as a
monotherapy in ovarian cancer in an ongoing DRP-guided Phase 2 clinical trial. Based on early data (unpublished) from this study and in
consultation with trial investigators and the Company's Scientific Advisory Board (SAB), Allarity has implemented a trial protocol
amendment to change patient dosing from once daily dose to a BID regimen (twice daily). The aim is to improve therapeutic benefit by providing
a consistent level of the drug in the patient throughout the treatment period. As a result of these efforts, Allarity anticipates that
it will have sufficient DRP-positive patient enrollment to support an interim data readout from this study in late 2023.
The dosing-related protocol amendment in the Phase
2 stenoparib monotherapy trial also aligns with the BID dosing strategy for Allarity's recently initiated Phase 1b combination study
of stenoparib and dovitinib for the treatment of advanced solid tumors.
Therapeutics, Inc. | 24 School Street, 2nd Floor | Boston, MA | U.S.A. | NASDAQ: ALLR | www.allarity.com
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.
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Therapeutics, Inc. | 24 School Street, 2nd Floor | Boston, MA | U.S.A. | NASDAQ: ALLR | 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
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 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 dovitinib or any of our other therapeutic candidates 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 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.
Senior V.P. of Investor Relations
Carrotize PR & Communications
Therapeutics, Inc. | 24 School Street, 2nd Floor | Boston, MA | U.S.A. | NASDAQ: ALLR | www.allarity.com