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October 13, 2020 / / -- At present, the new crown pneumonia epidemic is still spreading rapidly around the world.
according to Baidu's Real-Time Big Data Report on the Outbreak of New Coronavirus Pneumonia, as of 18:00 on October 13, 2020, more than 38.08 million cases and more than 1.086 million deaths had been confirmed worldwide.
, AstraZeneca announced that it will launch two Phase III clinical trials in the coming weeks to evaluate two combination therapies for long-acting antibodies (LAAB), the COVID-19 antibody cocktail therapy AZD7442.
the two trials will bring more than 6,000 subjects into the U.S. and a foreign group.
LAAB uses AstraZenecom's proprietary half-life extension technology to achieve durability of up to 6 to 12 months after a single drug is given.
combination of two LAAB types can also reduce the risk of drug resistance from new coronavirus (SARS-CoV-2).
AZD7442 is an antibody cocktail therapy for the prevention and treatment of COVID-19, consisting of two monoclonal antibodies from recovery patients with SARS-CoV-2 infection.
two types of monoantigens were discovered by Vanderbilt University Medical Center and licensed to AstraZeneta in June 2020.
AstraZeneca optimized these two monoantibodies, extending their half-life and reducing Fc-subject binding.
with extended half-life, LAAB should provide 6-12 months of protection against COVID-19.
reducing Fc-binding is designed to minimize the risk of disease's antibody dependence enhancement (ADE), a viral-specific antibody that promotes, rather than inhibits, infections and/or diseases.
Under an agreement with the U.S. Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Agency (BARDA), AstraZeneta has received approximately $486 million from the U.S. government to support the development and supply of AZD7442.
two Phase III trials initiated by the
program, one of which will recruit approximately 5,000 subjects, will assess the safety and effectiveness of AZD7442 in preventing infection for up to 12 months, and the other will recruit approximately 1,100 subjects to evaluate AZD7442 for post-exposure prophylaxis and pre-emptive treatment (pre-emptive treatment).
astraZeneta is planning more trials to evaluate AZD7442 for COVID-19 in about 4,000 adult patients.
plans to supply up to 100,000 doses by the end of 2020, and under another agreement, the U.S. government could get another 1 million by 2020.
Pascal Soriot, chief executive of AstraZeneta, said: "This agreement with the U.S. government will help accelerate the development of our long-acting antibody portfolio, which has the potential to deliver immediate and lasting results in the prevention and treatment of COVID-19 infections.
we will evaluate this LAAB combination in different contexts, from prevention and outpatient treatment to hospitalization, with a focus on helping the most vulnerable.
in a recent study published in the journal Nature, LAAB was shown in preclinical trials to block the binding of SARS-CoV-2 viruses to host cells and protect against infection in cell and animal disease models.
LAAB simulates natural antibodies and has the potential to provide a preventive therapy for people exposed to SARS-CoV-2 virus, as well as a treatment for patients infected with SARS-CoV-2 virus and to prevent progression.
LAAB combination therapy has the potential to be a complementary preparation for vaccines, for example, for people who are not suitable for vaccination or to provide additional protection for high-risk groups, it can also be used to treat infected people.
In addition to AstraZenecon, Regeneratives is also developing a COVID-19 antibody cocktail therapy REGN-COV2, which consists of two monoantigens, targeting two separate, non-overlapping bits in the SARS-CoV-2 ratchet protein binding region, with synergies that reduce the risk of virus mutation escape.
non-human primate data show that REGN-COV2 can prevent SARS-CoV-2 infection and treat infected animals by accelerating virus removal.
REGN-COV2 has been developed to treat and prevent COVID-19 infections.
currently, two Phase II/III clinical trials are being evaluated for the treatment of COVID-19 and one Phase III clinical trial is being evaluated for the prevention of COVID-19 in family contacts of infected persons.
mid-August this year, Roche and Regeneration Reached a partnership to develop, manufacture and distribute REGEN-COV2 around the world.
the therapy promises to provide an urgently needed treatment option for people who already have symptoms of COVID-19 and has the potential to slow the spread of the global pandemic by preventing infection among people at high risk of exposure to the virus.
, the two sides will increase the supply of REN-COV2 by at least 3.5 times from its current capacity and have the potential to further expand capacity, according to a joint statement.
will greatly increase the available doses for people in the United States and around the world.
() Original source: COVID-19 Long-Acting AntiBody (LAAB) group AZD7442 rapidly advances into Phase III clinical trials.