TIDMAZN
RNS Number : 7043B
AstraZeneca PLC
12 October 2020
9 October 2020 21:30 BST
COVID-19 Long-Acting AntiBody (LAAB) combination AZD7442
rapidly advances into Phase III clinical trials
Two trials of AZD7442 will enrol over 6,000 adults for the
prevention of COVID-19 with additional trials enrolling 4,000
adults for the treatment of SARS-CoV-2 infections
US Government to invest $486m for development and supply
of up to 100,000 doses and can acquire another one million
doses
AstraZeneca's long-acting antibody (LAAB) combination, AZD7442,
will advance into two Phase III clinical trials in more than 6,000
participants at sites in and outside the US that are due to begin
in the next weeks. The LAABs have been engineered with
AstraZeneca's proprietary half-life extension technology to
increase the durability of the therapy for six to 12 months
following a single administration. The combination of two LAABs is
also designed to reduce the risk of resistance developed by the
SARS-CoV-2 virus.
The Company has received support of around $486m from the US
Government for the development and supply of AZD7442 under an
agreement with the Biomedical Advanced Research and Development
Authority (BARDA), part of the Office of the Assistant Secretary
for Preparedness and Response at the US Department of Health and
Human Services, and the Department of Defense Joint Program
Executive Office for Chemical, Biological, Radiological and Nuclear
Defense.
One trial will evaluate the safety and efficacy of AZD7442 to
prevent infection for up to 12 months, in approximately 5,000
participants. The second trial will evaluate post-exposure
prophylaxis and pre-emptive treatment in approximately 1,100
participants.
AstraZeneca is planning additional trials to evaluate AZD7442 in
approximately 4,000 patients for the treatment of COVID-19.
AstraZeneca plans to supply up to 100,000 doses starting towards
the end of 2020 and the US Government can acquire up to an
additional one million doses in 2021 under a separate
agreement.
Pascal Soriot, Chief Executive Officer, said: "This agreement
with the US Government will help accelerate the development of our
long-acting antibody combination which has the potential to provide
immediate and long-lasting effect in both preventing and treating
COVID-19 infections. We will be evaluating the LAAB combination in
different settings from prophylaxis, to outpatient treatment to
hospitalisation, with a focus on helping the most vulnerable
people."
LAABs mimic natural antibodies and have the potential to treat
and prevent disease progression in patients already infected with
the virus, as well as to be given as a preventative intervention
prior to exposure to the virus. A LAAB combination could be
complementary to vaccines as a prophylactic agent, e.g. for people
for whom a vaccine may not be appropriate or to provide added
protection for high-risk populations. It could also be used to
treat people who have been infected.
Today's agreement builds on previous funding of more than $25m
from US government agencies BARDA and the Defense Advanced Research
Projects Agency for the discovery and evaluation of the monoclonal
antibodies, as well as the Phase I clinical trial started in August
2020(1) to assess safety, tolerability and pharmacokinetics of
AZD7442 in healthy individuals.
Financial considerations
The agreement is not anticipated to impact the Company's
financial guidance for 2020 as the US Government funding is being
offset by expenses to progress the clinical trials of AZD7442 as
well as manufacturing process and upscaling costs. Should the Phase
III trials prove successful and AZD7442 become an approved
medicine, the Company anticipates providing the medicine at
commercial terms during and after the current coronavirus
pandemic.
AZD7442
AZD7442 is a combination of two LAABs derived from convalescent
patients after SARS-CoV-2 infection. Discovered by Vanderbilt
University Medical Center and licensed to AstraZeneca in June 2020
, the LAABs were optimised by AstraZeneca with half-life extension
and reduced Fc receptor binding. The half-life extended LAABs
should afford six to 12 months of protection from COVID-19.(2-5)
The reduced Fc receptor binding aims to minimise the risk of
antibody-dependent enhancement of disease - a phenomenon in which
virus-specific antibodies promote, rather than inhibit, infection
and/or disease.(6)
In a recent Nature publication, the LAABs were shown in
pre-clinical experiments to block the binding of the SARS-CoV-2
virus to host cells and protect against infection in cell and
animal models of disease.(7)
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development and commercialisation of prescription medicines,
primarily for the treatment of diseases in three therapy areas -
Oncology, Cardiovascular, Renal & Metabolism, and Respiratory
& Immunology. Based in Cambridge, UK, AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. Please visit astrazeneca.com and
follow the Company on Twitter @ AstraZeneca .
Contacts
For details on how to contact the Investor Relations Team,
please click here. For Media contacts, click here.
References
1. ClinicalTrials.gov. NCT04507256.
https://clinicaltrials.gov/ct2/show/NCT04507256?term=NCT04507256&draw=2&rank=1
.
2. Robbie, G.J., et al., A novel investigational Fc-modified
humanized monoclonal antibody, motavizumab-YTE, has an extended
half-life in healthy adults. Antimicrob Agents Chemother, 2013.
57(12): p. 6147-53.
3. Griffin, M.P., et al., Safety, Tolerability, and
Pharmacokinetics of MEDI8897, the Respiratory Syncytial Virus
Prefusion F-Targeting Monoclonal Antibody with an Extended
Half-Life, in Healthy Adults. Antimicrob Agents Chemother, 2017.
61(3).
4. Yu, X.Q., et al., Safety, Tolerability, and Pharmacokinetics
of MEDI4893, an Investigational, Extended-Half-Life,
Anti-Staphylococcus aureus Alpha-Toxin Human Monoclonal Antibody,
in Healthy Adults. Antimicrob Agents Chemother, 2017. 61(1).
5. Domachowske, J.B., et al., Safety, Tolerability and
Pharmacokinetics of MEDI8897, an Extended Half-life Single-dose
Respiratory Syncytial Virus Prefusion F-targeting Monoclonal
Antibody Administered as a Single Dose to Healthy Preterm Infants.
Pediatr Infect Dis J, 2018. 37(9): p. 886-892.
6. Van Erp EA, Luytjes W, Ferwerda G and van Kasteren PB.
Fc-Mediated Antibody Effector Functions During Respiratory
Syncytial Virus Infection and Disease. Front. Immunol. 2019.
https://doi.org/10.3389/fimmu.2019.00548.
7. Zost SJ et al. Potently neutralizing human antibodies that
block SARS-CoV-2 receptor binding and protect animals. Nature.
2020. DOI: 10.1038/s41586-020-2548-6.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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