$157 Million! AstraZeneca Introduces Early-stage covid-19 Drug

On May 17, AstraZeneca announced a partnership with RQ Biotechnology to introduce an early-stage novel coronavirus monoclonal antibody. AstraZeneca will pay up to US$157 million for the exclusive global license of the drug. Specific information about the drug has not yet been disclosed.

With the deal, London-based RQ Biotechnology announced today. The company develops therapeutic and preventive therapies based on potent broad-spectrum monoclonal antibodies that provide immediate and long-lasting immunity to people at risk of serious illness or death from existing, emerging viral infections. The management comes from well-known pharmaceutical companies or research institutions such as Sanofi, Pfizer, Imperial College London, and Oxford University.

Previously, AstraZeneca has a long-acting neutralizing antibody combination AZD7442 (Evusheld, Tixagevimab + Cilgavimab) approved for marketing, for severely immunocompromised adults and adolescents over the age of 12 and those who should not be vaccinated against the new crown vaccine or immune response to the new crown vaccine Pre-exposure prophylaxis for underrepresented populations. The drug is the first neutralizing antibody combination approved for prevention, and has a long-acting advantage. A single intramuscular injection can achieve preventive immune protection for up to 12 months, which is more than 3 times that of ordinary neutralizing antibodies.

AZD7442 is a combination of two long-acting antibodies, tixagevimab (AZD8895) and cilgavimab (AZD1061), extracted from B cells of convalescent patients infected with SARS-CoV-2. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020. AstraZeneca uses its proprietary YTE half-life extension technology to optimize neutralizing antibodies to reduce Fc receptor and complement C1q binding for long-acting effects.

The drug's approval was based on data from the Phase III PROVENT study. The study included high-risk and immunocompromised subjects, more than 75% of whom had comorbidities. 5197 subjects were randomized 2:1 to receive 300 mg of AZD7442 (n = 3,460) or placebo (n = 1,737).

6-month follow-up data from prevention trials showed that a single intramuscular injection of the long-acting antibody combination reduced the risk of symptomatic COVID-19 by 83%; a separate treatment trial showed that treatment within three days of symptom onset reduces the risk of severe COVID-19 The risk of -19 or death was reduced by 88%.

In addition to the PROVENT study for prevention in high-risk patients, AstraZeneca started the Phase III TACKLE study in outpatients, announcing its positive results in mid-November 2021.