FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of August 2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Phase I clinical trial initiated for monoclonal antibody
combination for the prevention and treatment of
COVID-19
25 August 2020 07:00 BST
Phase I clinical trial initiated for monoclonal antibody
combination
for the prevention and treatment of COVID-19
First participants dosed in trial of AZD7442 to assess
safety,
tolerability and pharmacokinetics of the combination
The first participants have been dosed in a Phase I trial of
AZD7442, a combination of two monoclonal antibodies (mAbs) in
development for the prevention and treatment of
COVID-19.
The trial, called NCT04507256, will evaluate the safety,
tolerability and pharmacokinetics of AZD7442.1 The
trial will include up to 48 healthy participants in the UK
aged 18 to 55 years and is funded by the Defense Advanced Research
Projects Agency (DARPA), part of the US Department of Defense, and
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.
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "This trial is an important milestone in the
development of our monoclonal antibody combination to prevent or
treat COVID-19. This combination of antibodies, coupled to our
proprietary half-life extension technology, has the potential to
improve both the effectiveness and durability of use in addition to
reducing the likelihood of viral resistance."
Should AZD7442 prove to be tolerated and have a favourable safety
profile in the trial, AstraZeneca will progress it into larger
late-stage Phase II and Phase III trials to evaluate its efficacy
as a potential preventative and treatment approach against
COVID-19.
Synthesised in the laboratory, mAbs aim to mimic natural
antibodies. The treatment has the potential to be given as a
preventative option for people exposed to the virus, and to treat
and prevent disease progression in patients already infected by the
virus.
AZD7442
AZD7442 is a combination of two mAbs derived from convalescent
patients with SARS-CoV-2 infection. Discovered by Vanderbilt
University Medical Center and licensed to AstraZeneca in June 2020,
the mAbs were optimised by AstraZeneca with half-life extension and
reduced Fc receptor binding. The half-life extended mAbs should
afford at least six months of protection from
COVID-19.2-5 In
a recent Nature publication,
the mAbs were shown preclinically to block the binding of the
SARS-CoV-2 virus to host cells and protect against infection in
cell and animal models of disease.6
NCT04507256
NCT04507256 is a Phase I, first time in human, randomised,
double-blind, placebo-controlled, and dose escalation study that
aims to evaluate the safety, tolerability and pharmacokinetics of
AZD7442 in healthy participants.1 Data
readout is anticipated in the second half of
2020.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: 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. 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
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
25 August
2020
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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|
Title:
Company Secretary
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