Boston,
MA (July 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 initial results from its
European Phase 2 clinical trial evaluating the efficacy of IXEMPRA®
in metastatic breast cancer (mBC) patients selected with the
DRP®-IXEMPRA® companion diagnostic (CDx) candidate. Researchers
prescreened mBC patients using Allarity’s DRP®-IXEMPRA® CDx, a
complex transcriptomic signature comprising multiple mRNA
biomarkers of drug response/resistance. Patients were assigned a
DRP®-score, and those with scores above 67% were selected for
treatment with IXEMPRA®.
Of the 36 patients screened with the
DRP®-IXEMPRA® CDx, investigators identified five DRP® positive
patients. Among the evaluable patients assessed up to the data
evaluation cut-off, there were promising signs of clinical benefit
in four out of four evaluable cases:
- One partial responder (PR) (tumor
shrinkage of 66%).
- One partial responder (PR) (tumor
shrinkage of 59%).
- One patient experienced 24 weeks of
stable disease.
- One patient experienced 19 weeks of
stable disease.
“We are enthusiastic about these promising very
early trial results since the observed clinical benefit rate
exceeds what has been historically observed for IXEMPRA® treatment
without the DRP®-IXEMPRA® CDx patient selection. While still early,
these data suggest that the use of the DRP®-IXEMPRA® CDx for
patient selection and treatment may help identify mBC patients most
able to benefit from this course of treatment. Accordingly, the
DRP®-IXEMPRA® CDx, if approved, may provide clinicians with an
important diagnostic to guide patient treatment in this
hard-to-treat population," said Marie Foegh, M.D., Chief Medical
Officer of Allarity.
The study is in a very early stage of an ongoing
open-label, single-arm trial, at multiple sites in Europe,
evaluating the anti-tumor effect of IXEMPRA® in patients with
locally recurrent or metastatic breast cancer after previous
chemotherapies, including a taxane and an anthracycline. The
included patients received a maximum of three prior lines of
chemotherapies in the metastatic setting. Allarity recently amended
the clinical trial protocol, lowering the DRP® cut-off score in
order to include more likely responder patients while still
excluding those unlikely to respond to the drug. The ultimate
objective is to further refine the DRP®-IXEMPRA® CDx criteria and
broaden the enrollment of mBC patients who may substantially
benefit from this treatment. The Company anticipates an additional
interim data readout before the end of this year.
The DRP®-IXEMPRA® CDx is a transcriptomic
signature comprising 191 mRNA biomarkers that are collectively
predictive of tumor sensitivity or resistance to IXEMPRA®. Using
the DRP® CDx to select likely responder patients while excluding
likely resistant ones, Allarity aims to improve the benefit-risk
ratio of IXEMPRA® in metastatic or locally advanced breast cancer.
The U.S. FDA-approved IXEMPRA® label currently indicates a
monotherapy efficacy with an objective response rate (ORR) of 12.4%
and a clinical benefit rate (CBR) of 24.8% in metastatic or locally
advanced breast cancer. However, the initial data from the ongoing
DRP®-guided Phase 2 study of IXEMPRA® suggest that the
DRP®-IXEMPRA® CDx may identify a subset of patients who potentially
have an improved ORR and CBR as compared to monotherapy efficacy
indicated by the U.S. FDA-approved label for the drug. The
DRP®-IXEMPRA® CDx is a clinical stage companion diagnostic
candidate and has not yet been approved by the U.S. FDA or the
EMEA. Early trial results are insufficient to show statistical
significance and may not be a reliable indicator of subsequent
trial results based on a larger patient population.
IXEMPRA® was originally developed by Bristol
Myers Squibb and is approved for metastatic breast cancer patients
in the U.S., where it is marketed by R-PHARM U.S., LLC. Allarity
has the exclusive option rights for the development and
commercialization of IXEMPRA® in Europe.
Allarity’s Chief Executive Officer, James G.
Cullem, further stated, “We are encouraged by these promising,
early clinical data suggesting that mBC patients selected for
treatment with IXEMPRA® using our DRP® companion diagnostic
candidate for the drug may have substantially improved clinical
benefit versus unselected patients. Allarity looks forward to fully
enrolling and completing our ongoing Phase 2 trial for IXEMPRA®,
and remains enthusiastic about advancing this program towards
market approval in Europe and, if approved, providing European mBC
patients with first-time access to this beneficial drug.”
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 clinical-stage pipeline
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 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.
###
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 - press release - initial Ixempra data
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