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Regeneron says antibody for COVID-19 could be ready this year

Two antibody cocktails for COVID-19 could be available as early as this autumn

Clinical trial

Regeneron has kicked off an accelerated development programme for two antibody cocktails for COVID-19 that could be available as early as this autumn – assuming it works as hoped in clinical trials.

Those trials should get underway in June, according to Regeneron chief scientific officer George Yancopoulos, who told investors on a conference call that the drugs have emerged from the same antibody discovery platform as its Ebola drug EB3, which is heading towards an FDA verdict in October.

The biotech is simultaneously working to rapidly scale-up manufacturing of the drug with a goal to have ‘hundreds of thousands’ of doses of the two cocktails available by the end of August.

They have been selected from thousands of potent antiviral fully human antibodies generated against the coronavirus, said Yancopolous.

“With Ebola, we set the record of nine months from initiating the project to starting human trials. Now, we hope to break that record with five months from project initiation to the clinic,” he added.

The hope is that the antibodies could be used both to prevent infection and treat people who are already infected with SARS-CoV-2, the virus that causes COVID-19.

“We think that there's a very significant chance that these specifically designed, very potent neutralising antibodies will have a significant impact on the disease,” said Yancopolous.

Regeneron is already working with partner Sanofi to try to repurpose their anti-IL-6 antibody Kevzara (sarilumab) – approved to treat rheumatoid arthritis – as a COVID-19 treatment, and specifically for patients with acute respiratory distress syndrome (ARDS).

A small Chinese study gave an inkling that Kevzara could have a benefit, and so Regeneron started a phase 2/3 trial to test that hypothesis further in severely and critically ill COVID-19 patients.

Results in the severe group were disappointing, but there was some sign of efficacy in the critical group, and the study is continuing in these patients, while other trials are looking at higher doses across both patient groups.

The update was given as Regeneron reported a 33% surge in first-quarter revenues to $1.83bn, driven by Sanofi-partnered atopic dermatitis and asthma drug Dupixent (dupilumab) which rocketed up by 129% to $855m.

The gains were made despite some weakness for age-related macular degeneration blockbuster Eylea (aflibercept), which was affected by postponed treatments during the pandemic, particularly in March. Like many of its peers, Regeneron is expecting the pandemic’s impact to peak in the second quarter, with a recovery in the latter half of the year.

Eylea brought in $1.17bn in the three-month period, up by 9%, while checkpoint inhibitor Libtayo (cemiplimab) for skin cancer continued its steady build – growing by 179%. Regeneron books US sales of the drug, which were $62m, with Sanofi recording another $13m in ex-US revenues.

2020 could see a lot more momentum behind Libtayo, if its developers can translate positive results in non-small cell lung cancer (NSCLC) and basal cell carcinoma (BCC) into regulatory approvals.

Article by
Phil Taylor

7th May 2020

From: Research



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