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Regeneron Looks to Achieve “Passive Vaccination” with COVID-19 Antibody Cocktail
COVID-19 has already affected over 100 million people and claimed approximately 2.2 million lives. However, the arrival of several vaccines, notably the ones from Moderna, Pfizer, and AstraZeneca, have given hope to several countries. Yet, the demand for these vaccines is far higher than their supply necessitating other companies to continue exploring other ways to combat the pandemic.
On January 26th, New York-based Regeneron Pharmaceuticals announced that their cocktail antibody has shown 100% prevention of symptomatic infections. REGEN-COV (casirivimab and imdevimab) reduced levels and duration of viral shedding in asymptomatic infections in an ongoing Phase 3 trial that evaluated people at high risk of contracting COVID-19 due to exposure from family members [1].
The company believes that the cocktail has the potential to provide passive vaccination for the prevention of COVID-19. The announcement resulted in Regeneron’s shares rising by 1.6%. Interestingly, the data from the trial is also far superior to its competitor Eli Lilly’s bamlanivimab, which decreased the risk of COVID-19 infection by 80% in nursing home residents.
“These data using REGEN-COV as a passive vaccine suggest that it may both reduce transmission of the virus as well as reduce viral and disease burden in those who still get infected,” said George D. Yancopoulos, M.D., Ph.D., President, and Chief Scientific Officer at Regeneron.
“Even with the emerging availability of active vaccines, we continue to see hundreds of thousands of people infected daily, actively spreading the virus to their close contacts. The REGEN-COV antibody cocktail may be able to help break this chain by providing immediate passive immunity to those at high risk of infection, in contrast to active vaccines, which take weeks to provide protection.
Impressive Trial Data
REGEN-COV, a combination of two potent monoclonal antibodies, has received federal funds for manufacturing and development from the Biomedical Advanced Research and Development Authority (BARDA).
The cocktail antibody binds non-competitively to the virus’s spike protein, thus making it effective against mutations of the viral strain. Regeneron is expected to supply approximately 1.5 million doses to the US government.
The clinical trial, which is being run jointly with the National Institute of Allergy and Infectious Diseases, recruited approximately 2000 patients. The first set of data with 409 patients showed high efficiency of the antibody, which has already received emergency use authorization (EUA) from the FDA as of November 2020 for treating mild-moderate patients.
Adverse events were observed more frequently in the placebo group when compared to the group receiving the antibody (18% vs. 12%). One death and one COVID-19-related hospitalization were recorded in the placebo group, while none were in the treatment group. The complete Phase 3 results are expected in the second quarter.
“There are also many individuals who unfortunately may be immunocompromised and not respond well to an active vaccine or are otherwise unable to be vaccinated, and REGEN-COV has the potential to be an important option for these individuals. Overall, the REGEN-COV development program has demonstrated definitive anti-viral activity, and the collective data strongly suggest it can be effective both as a therapeutic and as a passive vaccine,” added Yancopoulos.
Capturing the Market
With vaccine supply shortage, challenges in logistics, absence of a national plan, Regeneron enters with a tremendous potential to capture the market. Although other biopharma can step up to fill up the vaccine shortage, it would take a while to do so.
Merck recently announced dropping out of the COVID-19 vaccine race citing poor data and focus on other COVID-19 treatments instead. Meanwhile, Johnson and Johnson is waiting on its Phase 3 data to begin production.
Based on their extremely promising data, Regeneron said it would discuss the results with federal regulators to potentially expand the antibody cocktail’s current EUA. This would not only help millions of people worldwide but also provide the company with a slight edge over the vaccine makers.
Related Article: Moderna Applies Two-Pronged Strategy to Fight against Coronavirus Variants
References
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Regeneron Secures $4.5 Billion Worth of Contracts from the US for Combating COVID-19
COVID-19: After Lilly, Regeneron Bags EUA for its Antibody Therapy
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