Fast-moving Regeneron eyes summer clinical trial for COVID-19 antibody cocktail therapy

During the 2018 outbreak of Ebola in Congo, Regeneron quickly developed a promising monoclonal antibody triplet therapy that’s now under review by the U.S. FDA. Now, amid the ongoing coronavirus pandemic, the biotech is at it again.

Regeneron scientists have isolated hundreds of neutralizing antibodies against the SARS-CoV-2 virus from a humanized mouse model as well as from humans who have recovered from COVID-19, the company said Tuesday.

The goal is to select the top two antibodies for a cocktail therapy, which can either be administered to at-risk people before exposure as a vaccine or as treatment for those already infected. If everything goes as planned, Regeneron aims to enter clinical studies by early summer.

All coronaviruses have a cell surface protein called the spike protein. It helps the virus binds to the host cell for an infection. Regeneron’s SARS-CoV-2 antibodies will target the spike protein in an attempt to block the interaction of the virus with the host.

Regeneron used its proprietary VelociSuite technologies to produce fully human antibodies against the novel coronavirus from genetically edited mice. It's the same platform the company used to design the Ebola antibody cocktail, called REGN-EB3, which it advanced into clinical studies four months after the August 2018 outbreak. In an interim analysis, the company said the therapy performed better at reducing the death rate than did an antibody triplet control, a single monoclonal antibody and Gilead Sciences’ small-molecule drug remdesivir, which is now billed as the most promising drug against COVID-19.

This time it took Regeneron a little over a month from when it expanded a collaboration with the U.S. Department of Health and Human Services (HHS) to focus on the novel coronavirus to isolating all those neutralizing antibodies for further screening.

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Regeneron is preparing for clinical-scale production with the goal of making hundreds of thousands of low prophylactic doses per month by the end of summer. It’s also working with the HHS’ Biomedical Advanced Research and Defense Authority to ramp up manufacturing capacity even further.

The idea of using blood from patients who have recovered from COVID-19 as a treatment against the novel coronavirus emerged about a month ago. During the early days of the outbreak, state-owned China National Biotec Group said that convalescent plasma showed positive outcomes when used on about a dozen critically ill patients in Wuhan, where the virus was first uncovered. At that time, antibodies were not separated from the plasma.

In a viewpoint article published last week in The Journal of Clinical Investigation, two researchers from Johns Hopkins University and Albert Einstein College of Medicine also argued that antibody-containing blood serum from recovered patients could be used in COVID-19, as there are no vaccines, monoclonal antibodies or drugs available to treat the disease.

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Several other teams are also working on antibodies to treat COVID-19. Takeda recently started development of a polyclonal antibody therapy dubbed TAK-888 that also works by concentrating the pathogen-specific antibodies from plasma collected from recovered patients or vaccinated people.

Scientists at Utrecht University, Erasmus University Rotterdam and its spinout biotech Harbour Antibodies recently described an antibody that targets the spike glycoproteins on the viral surface. It showed cross-neutralizing activity in lab dishes against both SARS-CoV-2 and the SARS coronavirus that caused an outbreak in 2002 and 2003. The study’s co-senior author Frank Grosveld recently told Erasmus Magazine that the team is trying to get a pharma company on board to produce the candidate on a large scale.

Harbour Antibodies’ parent company, Chinese firm Harbour BioMed, has recently entered into a multiyear collaboration with Mount Sinai Health System to develop antibodies for various diseases, including the new coronavirus.

Meanwhile, Vir Biotechnology is in coronavirus monoclonal antibody collaborations with WuXi Biologics and Biogen.