COVID drugs come in 3 flavors; it’s time for more diversity

A scanning electron microscope image shows SARS-CoV-2 (yellow). Credit: NIAID-RML

Our industry’s response to COVID-19 defied the conventional wisdom that it takes years to deliver new drugs.

Makers of monoclonal antibodies led the pack, most notably Regeneron (NSDQ:REGN), which manufactured the 8-g, two-antibody cocktail administered to then-President Donald Trump last fall. Eli Lilly (NYSE:LLY) and Vir Biotechnology (NSDQ:VIR) pulled off similar feats. Prior speed records were measured in years, not months.

Vaccine developers moved even larger mountains. The colossal trials required to assess efficacy and safety — 30,000 to 60,000 volunteers each — were planned, executed and submitted to the FDA in under a year. Most thought it couldn’t be done in under a decade.

And small-molecule drug makers made important contributions too. Despite all the controversy surrounding the red herrings hydroxychl…

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Novel COVID-19 vaccine could offer broad immune responses across SARS-CoV-2 variants

The emerging biotech Gritstone Bio (NSDQ:GRTS) has dosed the first patient with its second-generation COVID-19 vaccine known as GRT-R910. The University of Manchester and Manchester University NHS Foundation Trust are jointly overseeing the U.K.-based Phase 1 study.

The GRT-R910 vaccine uses self-amplifying mRNA (SAM), which could optimize antigen expression at lower doses relative to conventional mRNA. The GRT-R910 vaccine targets antigens from the spike protein and highly conserved non-spike proteins on the SARS-CoV-2 virus.

Emeryville, California–based Gritstone believes the vaccine could offer a strong and durable immune response to various SARS-CoV-2 variants. It may also eliminate the need for repeat boosters, the company concluded.

The company believes that the technology will outperform the first generation of mRNA COVID-19 vaccines in those 60 and older.

“Our SAM COVID vaccine is designed to drive robust CD8+ T cell responses, in addition…

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How Delta could change the COVID-19 landscape

[Image courtesy of CDC]

Delta is “an extremely transmissible variant and has taken us all for a loop,” said Dr. Monica Gandhi, a professor of medicine and associate division chief of the division of HIV, infectious diseases and global medicine at University of California, San Francisco.

But despite Delta’s hurricane-like ascent, the volume of infections it drives are likely to fall just as quickly after peaking, Gandhi said in a webinar from the Bay Area Council.

Delta could peak anywhere from mid-August to mid-October, according to several experts quoted in WebMD.

In the interim, Delta will remain most threatening for the unvaccinated and those without prior COVID-19 infections, although the variant will likely continue to drive breakthrough infections in vaccinated individuals.

In highly vaccinated areas of the U.S. where the vaccine has spread, there has been a “decou…

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Moderna’s COVID-19 vaccine holds its own against Delta variant in study

A small study indicated that Moderna’s messenger RNA COVID-19 vaccine was effective against the Delta variant.

Using serum samples from eight Phase 1 participants drawn one week after administering the second dose of the vaccine, the analysis found a 2.1-fold reduction in neutralizing titers against the Delta (B.1.617.2) variant relative to the ancestral strain of the virus.

The World Health Organization has urged the public  — including the fully vaccinated — to continue wearing masks and practice social distancing to reduce the spread of the Delta variant.

In related news, Moderna’s COVID-19 also won emergency use authorization in India, where scientists first identified the Delta variant.

The variant is gaining traction in the U.S. and will likely gain dominance in the coming weeks.

The vaccine appears to also offer protection against the Beta (B.1.351), Gamma (P.1), Kappa (B.1.617.1) and Eta (B.1.525) variants, although the reduction in…

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HHS halts distribution of Lilly’s bamlanivimab/etesevimab antibody cocktail

U.S. government authorities have decided to immediately pause the distribution of Eli Lilly’s bamlanivimab and etesevimab over concerns that the monoclonal antibody cocktail is ineffective against some SARS-CoV-2 variants.

CDC recently concluded that the Gamma variant (P.1) and the Beta variant (B.1.351) make up 11% of COVID-19 infections. They are also continuing to become more dominant, as is the Delta variant (B.1.617.2). CDC has determined that the Delta variant is possibly less responsive to some monoclonal antibody treatments.

The Beta and Gamma variants are significantly less responsive to bamlanivimab and etesevimab than other viral lineages.

Bamlanivimab and etesevimab image courtesy of Lilly.

FDA is recommending Regeneron’s REGEN-COV and GSK’s sotrovimab as more robust antibody therapies.

In related news, FDA recently granted emergency use authorization to tocilizumab, a monoc…

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