AstraZeneca plc AZN announced the initiation of phase I study on AZD7442, a monoclonal-antibody combination for the prevention and treatment of COVID-19. AZD7442 is a combination of two monoclonal antibodies, AZD8895 and AZD1061, which were derived from convalescent patients with SARS-CoV-2 infection, which AstraZeneca licensed from Vanderbilt University in the United States in June 2020.
The phase I study (NCT04507256) will include 48 healthy participants in the UK aged 18 to 55 years and will evaluate the safety, tolerability and pharmacokinetics of AZD744. Data from the study is expected later this year. If the data is positive, AstraZeneca will progress AZD7442 into larger late-stage phase II and phase III studies.
AstraZeneca has secured funding support from the Defense Advanced Research Projects Agency, part of the U.S. Department of Defense and BARDA for the phase I study and for manufacturing AZD7442.
In July, the UK government announced an agreement in principle with AstraZeneca for the supply of one million doses of AZD7442, with deliveries anticipated to start as early as first half of 2021, should AZD7442 prove to be tolerated and effective in clinical studies.
AstraZeneca identified AZD7442, after the evaluation of more than 1,500 antibodies for their ability to bind and neutralize the SARS-CoV-2 virus spike protein.
Regeneron Pharmaceuticals REGN is also developing an antibody-cocktail treatment, REGN-COV2, which is being tested in two phase II/III clinical studies to treat COVID-19.
AstraZeneca shares have risen 14.3% so far this year compared with the industry’s increase of 2%.
AstraZeneca is also developing a COVID-19 vaccine, AZD1222 in partnership with Oxford University. AZD1222 is currently being evaluated in phase II/III study in the UK, Brazil and South Africa with a late-stage study due to start in the United States with 30,000 participants in the third quarter of 2020. Data from the phase I/II study on AZD1222 announced in July, showed that the vaccine candidate generated strong antibody and T-cell responses in the majority of patients. Moreover, the company has signed supply deals with several countries under which it has committed to supply more than 2 billion doses of the vaccine, if it is successfully developed. Meanwhile, it has received more than $1 billion in funding from BARDA for the development, production and delivery of the AZD1222 vaccine. The company targets to file a regulatory application to the FDA later this year. Earlier this week, a Financial Times report stated that the FDA may grant emergency use authorization (EUA) to AZD1222.
AstraZeneca is one of the dozen companies developing a vaccine for the deadly coronavirus disease. Of these, other than AstraZeneca/Oxford University, Moderna MRNA, Pfizer PFE and its Germany-based partner, BioNTech have initiated phase III studies on a coronavirus vaccine. J&J expects to initiate a pivotal phase III study in September.
AstraZeneca currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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