BOSTON and SYDNEY (July 31, 2023) — Allarity Therapeutics, Inc.
(Nasdaq: ALLR) (“Allarity”), a clinical-stage pharmaceutical
company developing novel oncology therapeutics together with
drug-specific DRP® companion diagnostics for personalized cancer
care, and Detsamma Investments Pty. Ltd. trading as “FivepHusion,”
an advanced clinical-stage biotechnology company developing
Deflexifol™, an optimized all-in-one formulation of the
chemotherapeutic agent 5-fluorouracil (5FU) and its biomodulator
leucovorin (LV), announced today that the two companies have
entered into a Clinical Collaboration Agreement. Under this
agreement, Allarity will support FivepHusion’s future clinical
development of Deflexifol™ for the treatment of solid tumors by
using certain of Allarity’s drug-specific DRP® companion
diagnostics, including its validated DRP®-5FU companion diagnostic,
to potentially select patients for enrollment and treatment in
clinical trials of Deflexifol™ as a monotherapy and in combination
with other drugs.
Deflexifol™ is a novel anti-cancer drug reformulation designed
to address the safety and efficacy limitations of standard-of-care
5FU chemotherapy. It combines, in a single infusion, 5FU and LV, a
drug that potentiates 5FU anti-tumor activity, to improve the
therapeutic activity of 5FU. FivepHusion expects to start a phase
1b/2a study investigating Deflexifol™ in combination with
oxaliplatin (“DEFLOX”) and bevacizumab in the 1st line treatment of
unresectable metastatic colorectal cancer (mCRC) patients in H2
2023. This ~50 patient trial is designed to evaluate the safety,
tolerability and pharmacokinetics of Deflexifol™ in the DEFLOX plus
bevacizumab regimen, to enable selection of the optimal Deflexifol™
dose to be utilized in a Phase 3 pivotal trial in 1st line
treatment of unresectable mCRC. A secondary endpoint is the
assessment of objective response (eight-week scan) and overall
survival of patients treated with DEFLOX plus bevacizumab.
Allarity’s DRP®-5FU is a companion diagnostic (CDx) that has
been retrospectively validated and shown to predict patient
response to 5FU treatment in late-stage colorectal cancer. Clinical
data showing the predictive ability of the DRP®-5FU CDx in
colorectal cancer were presented at the annual congress of the
European Society for Medical Oncology (ESMO) in Barcelona on
September 29, 2019, and were later the same year published in the
scientific journal Annals of Oncology.
Dr. Christian Toouli, CEO and Managing Director of FivepHusion,
said, “We are excited to collaborate with Allarity Therapeutics to
evaluate the drug-specific DRP® companion diagnostic technology as
part of our upcoming Deflexifol™ phase 1b/2a trial in 1st line
unresectable metastatic colorectal cancer. This collaboration has
the potential to develop an exciting precision medicine companion
diagnostic for oncologists, facilitating administration of
Deflexifol™ to likely patient responders as a superior treatment
for a range of solid tumours with significant unmet medical
need.”
James G. Cullem, CEO of Allarity Therapeutics, added, “Allarity
is thrilled to work together with FivepHusion to support the
clinical advancement of their lead Deflexifol™ program by
evaluating the potential of DRP® companion diagnostics to select
cancer patients most likely to respond to this novel and improved
formulation of the widely-used chemotherapeutic 5FU. Together with
the FivepHusion team, we look forward to advancing true
personalized cancer care by using DRP® companion diagnostics to
help provide Deflexifol™ to patients that will most likely benefit
from this promising therapeutic candiate.”
The Clinical Collaboration
Agreement
Under the terms of the Clinical Collaboration Agreement,
Allarity will initially support FivepHusion’s planned Phase 1b/2a
trial of DEFLOX plus bevacizumab in 1st line treatment of
unresectable mCRC, which will be conducted at trial sites in
Australia. Allarity will receive patient biopsies from the trial
and analyze them using the DRP® companion diagnostics technology to
identify patients most likely to respond or not respond to the
DEFLOX plus bevacizumab regimen. This analysis will be conducted
blindly (without knowledge of any patient data and/or actual
clinical response to the drug), so as to enable the retrospective
analysis of the DRP® companion diagnostics predictive power
following the completion of the Phase 1b/2a trial. FivepHusion will
receive a first option to negotiate and obtain from Allarity a
global, exclusive license to use and commercialize the DRP®-5FU CDx
(together with other DRP® CDx relevant to drug combinations
including Deflexifol™) through Phase 3 registration trials,
regulatory approval, and to market.
Following conclusion of the Phase 1b/2a study, FivepHusion will
determine whether the ability of the DRP® companion diagnostics
technology to select patients responsive to DEFLOX plus bevacizumab
and/or Deflexifol™ monotherapy warrants prospective use of the
companion diagnostic(s), to select and enroll mCRC patients, in an
international, Phase 3 registration study for the drug. Allarity
will receive patient biopsies from the trial and analyze them using
the DRP® companion diagnostics technology to prospectively identify
patients most likely to respond or not respond to
Deflexifol™. Allarity will further assist FivepHusion
in the preparation and submission of any regulatory approvals,
including Investigational Device Exemptions (IDEs) and Pre-Market
Approvals (PMAs), required to use the DRP® companion diagnostics
technology in such a Phase 3 trial and to use and market the CDx
following any regulatory approval of Deflexifol™.
Financial terms of the clinical collaboration, option and
potential license are not disclosed. If FivepHusion exercises its
option right and receives a license to the Allarity DRP® companion
diagnostic technology related to Deflexifol™, Alliarty will receive
certain milestone payments triggered by regulatory approvals of
Deflexifol™ and attainment of drug sales benchmarks.
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; dovitinib, a pan-tyrosine kinase inhibitor
previously 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, and is 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.
About FivepHusion and
Deflexifol™
FivepHusion (www.fivephusion.com) is an advanced clinical-stage,
globally focused biotechnology company whose purpose is to optimise
chemotherapy to improve patient treatment and quality of life. Its
lead program, Deflexifol™, is a proprietary, novel, and optimized
physiological pH formulation of the chemotherapeutic agent
5-fluorouracil (5FU) and its biomodulator leucovorin (LV) for the
treatment of solid tumours. Current formulations of 5FU and LV are
the standard of care for modern treatment of metastatic colorectal
cancer (mCRC) and are also frequently utilized to treat a range of
other highly incident tumors, including colorectal, breast,
gastric, head & neck and pancreatic cancers. However, current
formulations of 5FU and LV suffer from limitations in their safety,
tolerability, effectiveness and pharmacological compatibility.
These disadvantages contribute to limited treatment response rates,
unpleasant side effects and toxicities, and a reduced quality of
life experienced by cancer patients. Deflexifol™ has been designed
to address these limitations, with clinically demonstrated
improvements in safety and tolerability and the potential to offer
superior anti-tumor efficacy, better quality of life, and overall
enhanced clinical benefit for cancer patients.
FivepHusion is developing Deflexifol™ as a bioequivalent,
chemotherapy replacement of sub-optimal standard of care
formulations of 5FU and LV for the treatment of mCRC, and other
tumors with a projected global incidence of greater than 6 million
patients. Deflexifol™ is also being developed as a new therapy for
cancers with high unmet medical need, such as pediatric ependymoma;
a rare and deadly brain cancer which afflicts very young
children.
Deflexifol™ is a trademark of FivepHusion.
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Allarity 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,” “toward,” “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 Company’s ability to
maintain compliance with the Nasdaq Listing Rule, use of proceeds
from the offering, that the closing of offering will occur or will
occur on the anticipated closing date, ability to raise capital,
statements related to the expected availability capital to fund its
anticipated clinical trials, statements related to advancing
dovitinib in combination with 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, and 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, including, but not limited to,
Deflexifol™. 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
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 S-1 registration statement 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.
FivepHusion Forward-Looking
Statements
This announcement (and any attachments) may contain
certain forward-looking statements that are based on any number of
assumptions and estimates which may prove incorrect and relate to
circumstances and events that may not take place. Forward-looking
statements involve known and unknown risks, uncertainties, and
other factors (such as significant business, economic and
competitive uncertainties and contingencies, and regulatory and
clinical development risks and uncertainties) which may cause the
actual future plans, results or the performance of FivepHusion and
its drug Deflexifol™ to differ materially from the plans, results
or performance expressed or implied by such forward-looking
statements. Past performance is not a reliable indicator of future
performance. There can be no assurance that any forward-looking
statements will be realised. FivepHusion does not make any
representation or give any warranty as to the likelihood of
achievement or reasonableness of any forward-looking
statements.
###
Allarity Company
Contact: investorrelations@allarity.com
Allarity U.S. Media
Contact: Mike
Beyer Sam Brown,
Inc. +1 (312)
961-2502
mikebeyer@sambrown.com Allarity
EU Media
Contact: Thomas
Pedersen Carrotize
PR &
Communications +45
6062 9390
FivepHusion Company and Media Contact:
Dr. Christian Toouli
CEO & Managing Director
c.toouli@fivephusion.com
- Allarity and FivepHusion Clinical Collaboration Press
Release
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