AstraZeneca's Coronavirus Antibody Therapy to Enter Late Stage
AstraZeneca plc AZN announced that it will initiate two Phase III studies to evaluate AZD7442, a combination of monoclonal antibodies used in the prevention and treatment of COVID-19, over the next few weeks.
One study evaluates AZD7442 for safety and effectiveness in preventing COVID-19 infection for up to 12 months, while another study evaluates the candidate for post-exposure prophylaxis and preventive treatment of the deadly coronavirus. The company also plans to initiate additional studies evaluating AZD7442 for the treatment of COVID-19.
We note that the company is accelerating development of AZD7442 after the start of its Phase I study in August 2020. AZD7442 is a combination of two monoclonal antibodies, AZD8895 and AZD1061, that are derived from convalescent patients with SARS- CoV-2 infection. The company in-licensed the same license from Vanderbilt University in the US in June.
In addition, AstraZeneca received approximately $ 486 million in funding under an agreement to develop and supply AZD7442 in the United States. The funding agreement was signed with the Department of Advanced Biomedical Research and Development ("BARDA") and the Executive Office of the Department of Defense's Joint Program on Chemical, Biological, Radiological and Nuclear Defense. Under the terms of this contract, AstraZeneca will deliver up to 100,000 cans from the end of this year. The U.S. government is entitled to an additional million cans in 2021 under a separate contract.
In July, the UK government announced a general agreement with AstraZeneca for the supply of one million cans of AZD7442. Deliveries are expected to begin as early as the first half of 2021 if AZD7442 should prove to be well tolerated and effective in clinical studies.
AstraZeneca's shares are up 9.8% so far this year, compared to the industry's 0.5% gain.
Significantly, AstraZeneca is working with Oxford University to develop a coronavirus vaccine candidate AZD1222 in several late-stage studies around the world. However, the US phase III study is being discontinued by the FDA.
Several other pharmaceutical companies are now developing treatments for COVID-19. Gilead's GILD Veklury (Remdisivir) is the only antiviral treatment to have received an Emergency Authorization ("EUA") for COVID-19 infection. In addition, several ongoing international phase III studies are evaluating the safety and effectiveness of remdesivir in combating SARS-CoV-2 infection.
Earlier this month, Regeneron REGN and Eli Lilly LLY filed with the FDA for an EUA of their two experimental COVID-19 treatments, REGN-COV2 and LYCoV555, respectively.
Regeneron's antibody treatment was recently hailed by President Donald Trump, who received the same treatment after testing positive for COVID-19. The company also signed an agreement with BARDA and the Department of Defense Joint Program for $ 450 million in funding for the manufacture and supply of REGN-COV2.
In addition, Vir Biotechnology, together with partner Glaxo, is evaluating its monoclonal antibody candidate VIR-7831 for the early treatment of COVID-19 in a phase III study.
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AstraZeneca currently has a Zacks Rank 3 (Hold). The full list of today's Zacks # 1 Rank (Strong Buy) stocks can be found here.
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