- The DRP®-Dovitinib companion diagnostic
demonstrated an ability to identify advanced renal cell carcinoma
patients that have improved clinical benefit from dovitinib
treatment, as compared to unselected patients
BOSTON (August 30, 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, announced today the publication of
its clinical validation of a novel drug-specific DRP®-companion
diagnostic (CDx) for dovitinib in the peer-reviewed journal PLOS
ONE. Data showed that the DRP®-Dovitinib CDx was able to identify a
subgroup of advanced renal cell carcinoma (RCC) patients that have
improved clinical benefit from treatment with dovitinib, as
compared to unselected patients. PLOS ONE published the paper
online today titled, “A novel drug-specific mRNA biomarker
predictor for selection of patients responding to dovitinib
treatment of advanced renal cell carcinoma and other solid
tumors.”
“Having our work published in PLOS ONE underscores the
importance and potential impact of our DRP®-Dovitinib CDx in
oncology,” said Allarity’s Chief Scientific Officer and Study
Author Dr. Steen Knudsen. “This is the first validated predictive
biomarker in renal cell carcinoma, a long-standing goal in
potentially improving the treatment of these patients. An
additional prospective trial would be required before RCC patients
that are candidates for dovitinib can benefit from this diagnostic
breakthrough. This DRP® publication marks yet another important
step forward in Allarity’s mission to redefine cancer treatment
paradigms and realize true personalized cancer care.”
Dovitinib is a pan-targeted kinase inhibitor (pan-TKI) formerly
developed through Phase 3 clinical studies. The DRP®-Dovitinib
CDx is a complex transcriptomic signature comprising 58 mRNA
biomarkers that are collectively predictive of tumor response to
the drug. In the study evaluating pre-treatment
biopsies of 135 advanced RCC patients, the DRP® positive subgroup
(indicating that the patient was likely to respond) (N=49) had a
median overall survival of 15 months (96% CI 12.94-26.25), whereas
the DRP® negative subgroup (N=86) had a median overall survival of
9.13 months (95% CI 7.49-13.2). The hazard ratio was 0.60 (95% CI
0.39-0.91).
In addition to the 135 RCC biopsies, the DRP®-Dovitinib showed
equally promising data in a number of other solid tumors, such as
hepatocellular carcinoma (HCC), thereby demonstrating that it is
independent of tumor type and has applicability beyond RCC.
The PLOS ONE article is Allarity’s 14th peer-reviewed
publication of data from clinical validations of DRP® companion
diagnostics for a range of different cancer therapeutics, further
establishing the robustness of the DRP® platform.
Dovitinib has been the focus of numerous clinical studies,
showing promising properties as an anti-cancer agent, but is not
yet approved for the treatment of any cancer type. It is currently
being advanced by Allarity in an ongoing Phase 1b clinical study
exploring the potential synergy of dovitinib and stenoparib (a PARP
inhibitor) for the treatment of advanced solid tumors, including
ovarian cancer. In addition, in partnership with Allarity,
Oncoheroes Biosciences has an ongoing program to develop dovitinib,
together with the DRP®-dovitinib CDx, as a treatment for pediatric
osteosarcoma. 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,”
“towards,” “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 maintain 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
- Allarity Therapeutics - Press Release PLOS ONE
DRP-Dovitinib
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