Current positive results with delta variant
B.1.617.2 follows previous pre-clinical tests,
including testing of alpha variant B.1.1.7 (“British”
variant),beta variant B.1351 (“South African” variant),
and gamma variant P.1 (“Brazilian” variant).
Allarity Therapeutics is planning to submit
findings to U.S. National Institutes of Health (NIH) for funding
opportunities as part of the new Antiviral Program for Pandemics
(APP)
Press
ReleaseHørsholm,
Denmark (November
11,
2021) – Allarity
Therapeutics A/S (“Allarity” or the “Company”) today announced
positive results from the further pre-clinical testing of the
antiviral activity of its oral PARP inhibitor, stenoparib, against
Coronavirus variant B.1.617.2 (delta variant).
The current in-vitro studies, focusing on
SARS-CoV-2 lineage B.1.617.2, follow previous, positive
pre-clinical test results with stenoparib as a treatment of
SARS-CoV-2 first announced on August 26, 2020, and since published
in the peer-review journal mBio (mbio.asm.org) on January 19, 2021.
The data announced in August 2020 showed that stenoparib inhibits
SARS-CoV-2 as a single agent, and, in combination with remdesivir,
was also active in inhibiting the virus. The concentration of
stenoparib required for virus inhibition was lower in the
combination study with remdesivir than in the single-agent study.
In addition, the Company announced, on August 5, 2021, further
pre-clinical tests that had shown stenoparib also inhibits
SARS-Cov-2 variants, including alpha variant B.1.1.7 (“British”
variant), beta variant B.1351 (“South African” variant), and gamma
variant P.1 (“Brazilian” variant).
The additional pre-clinical results announced
today show that stenoparib demonstrated antiviral activity
inhibiting the delta variant in a dose-dependent manner in Vero E6
cells. The delta variant used for the experiments carries an
additional deletion in ORF7a, a rapidly spreading mutation. The
tests have been conducted by the Viroclinics-DDL Diagnostics
Laboratory (Rotterdam, The Netherlands). A planned scientific
publication will provide additional details of the experimental
conditions.
Currently, the delta variant (lineage B.1.617.2)
has become the dominant strain of SARS-CoV-2. Stenoparib is one
therapeutic candidate that has been shown to be a potential
treatment for patients infected with SARS-Cov-2 or several of its
currently known variants based in ongoing or completed pre-clinical
tests conducted by two independent laboratories, Viroclinics-DDL
and the Pathogen and Microbiome Institute at Northern Arizona
University, a leading U.S. infectious disease research
center.
Steve Carchedi, CEO of the
Company, said, “Allarity Therapeutics remains committed to
developing novel treatments that change the course of disease in
areas of high unmet need. Our ongoing research and development work
with stenoparib as a potential anti-viral treatment for COVID-19 is
no exception, particularly as new variants emerge as an ongoing
problem. We are proud to be among the companies uncovering possible
new treatments for COVID-19 and its currently known variants.”
Allarity plans to submit pre-clinical findings
to the NIH as part of a new U.S. federal government program, the
APP. Funding opportunities include those under the newly announced
Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic
Concern within the U.S. National Institute of Allergy and
Infectious Diseases (NIAID). AViDD aims to develop safe and
effective antivirals to combat SARS-CoV-2, the virus that causes
COVID-19, as well as to build sustainable platforms for targeted
drug discovery and development of a robust pipeline of antivirals
against viruses with pandemic potential. The NIH has recently
stated its interest in identifying and supporting new
orally-administered, single pill drugs that can impede Coronavirus
function before the onset of the respiratory inflammatory response
that causes fatality from viral infection. Any funding received
would be used for further pre-clinical studies and possible
clinical trials which would be necessary before any application to
the U.S Food and Drug Administration or other non-U.S. governmental
authority could be made to market stenoparib as an anti-viral
treatment for COVID-19.
Allarity Therapeutics is currently advancing
stenoparib for the treatment of advanced ovarian cancer in a Phase
2 clinical trial at the Dana-Farber Cancer Institute using a DRP®
companion diagnostic to guide patient enrollment and improve
therapeutic outcome, and is currently expanding this study with
additional trial sites in the U.S. and Europe. Stenoparib is a
novel small molecule (oral), targeted inhibitor of Poly ADP-Ribose
Polymerase (PARP), a key DNA damage repair enzyme active in cancer
cells.
Allarity holds global, exclusive rights to
stenoparib under an existing license with Eisai Co., Ltd. (Tokyo,
Japan) in the fields of cancer therapy as well as anti-viral
therapy.
About Allarity
Therapeutics Allarity Therapeutics (Nasdaq First
North Growth Market Stockholm: ALLR.ST) develops drugs for
personalized treatment of cancer guided by its proprietary drug
response predictor technology, the DRP® platform. The Company has a
mature portfolio of five drug candidates, including compounds in
the pre-registration stage. The product portfolio includes:
stenoparib (2X-121), a PARP inhibitor in Phase 2 for ovarian
cancer; dovitinib, a pan-TKI in post-Phase 3 for renal cell
carcinoma; IXEMPRA® (Ixabepilone), a microtubule inhibitor approved
in the U.S. for the treatment of breast cancer; LiPlaCis®, a
liposomal formulation of cisplatin in Phase 2 trials for breast and
prostate cancer, currently being developed by Smerud Medical
Research International; and 2X-111, a liposomal formulation of
doxorubicin under manufacturing for Phase 2 in breast cancer,
currently being developed by Smerud Medical Research International.
In 2021, Allarity sold the global rights to Irofulven, a DNA
damaging agent in Phase 2 for prostate cancer, back to Lantern
Pharma, Inc.
About
VIROCLINICS-DDLVIROCLINICS-DDL is a global leading
specialty contract research organization, serving the
biopharmaceutical community with a broad range of pre-clinical
research, clinical diagnostic, assay development, and clinical
trial logistic services. A global reach is offered to our clients
through a network of 35 processing laboratories. VIROCLINICS-DDL’s
extensive experience with clinical and pre-clinical studies for
viruses, including its specialty in respiratory and blood borne
viruses, puts the company at the forefront in supporting the
development of vaccines, antibodies, and antiviral compounds
targeting viral infectious diseases. Our in-house state of the art
pre-clinical and clinical BSL-2 and BSL-3 laboratories allow for
complex experiments with highly pathogenic organisms.
VIROCLINICS-DDL is based in Rotterdam, Rijswijk, Schaijk, (The
Netherlands) and employs more than 300 well-trained, dedicated
scientists and technical experts.
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, the response rate can be
significantly increased. The DRP® method builds on the comparison
of sensitive vs. resistant human cancer cell lines, including
genomic information from cell lines combined with clinical tumor
biology and prior clinical trial outcomes. DRP® is based on
messenger RNA from the patient’s biopsies. DRP® has proven its
ability to provide a statistically significant prediction of the
clinical outcome from drug treatment in cancer patients in nearly
40 clinical studies that were examined, including an ongoing,
prospective Phase 2 trial. The DRP® platform can be used in all
cancer types and is patented for more than 70 anti-cancer
drugs.
Follow us on social media:
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https://www.linkedin.com/company/allaritytx/ Twitter:
https://twitter.com/allaritytx
Forward-looking statements This
announcement includes forward-looking statements that involve
risks, uncertainties and other factors, many of which are outside
of Allarity’s control and which could cause actual results to
differ materially from the results discussed in the forward-looking
statements. Forward-looking statements include statements
concerning Allarity’s plans, objectives, goals, future events,
performance and/or other information that is not historical
information. All such forward-looking statements are expressly
qualified by these cautionary statements and any other cautionary
statements which may accompany the forward-looking statements.
Allarity undertakes no obligation to publicly update or revise
forward-looking statements to reflect subsequent events or
circumstances after the date made, except as required by law.
###
Investor Contacts:
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
Certified Adviser: Svensk
Kapitalmarknadsgranskning AB, Email: ca@skmg.se. Tel: +46 11 32 30
732
This information is information that Allarity
A/S is obliged to make public pursuant to the EU Market Abuse
Regulation. The information was submitted for publication
on November 11,
2021.
- Press Release_Stenoparib COVID Delta Variant
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