Efforts underway to accelerate patient
recruitment and amend protocols
to improve patient outcomes.
Interim data readouts for both studies
anticipated in H2 2023.
Press
release
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 studies.
“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 Based on early data (unpublished) from this study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.
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
Facebook:
https://www.facebook.com/AllarityTx
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: Thomas
Jensen Senior V.P.
of Investor
Relations 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 - Clinical Update
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