Two new SARS-CoV-2 antibodies could neutralize COVID-19 strains with high efficacy

This scanning electron microscope image shows SARS-CoV-2 in yellow. [Image courtesy of NIAID RML]

Researchers at Tel Aviv University have identified two monoclonal antibodies that are broadly effective against SARS-CoV-2 variants.

The researchers investigated the activity of nine anti-SARS-CoV-2 monoclonal antibodies (mAbs) against several variants of concern, including alpha, beta, gamma, delta and omicron.

The scientists at the Tel Aviv University’s Sackler Faculty of Medicine suspect that the antibodies may reduce the future need for regular boosters.

The research was published in Communications Biology.

Natalia Freund and doctoral students Michael Mor and Ruofan Lee at Tel Aviv University led the research in collaboration with Ben Croker of the University of California at San Diego. Other research partners included Ye Xiang, a professor at Tsinghua University in Beijing and professors Me…

Read more
  • 0

AstraZeneca paying up to $157M for broad-spectrum monoclonal antibodies against COVID

RQ Biotechnology (London) emerged from stealth mode today, saying that AstraZeneca will pay it up to $157 million plus royalties for its existing mAbs against SARS-CoV-2.

“Our vision is to build on our successful debut with neutralizing antibody therapy for SARS-CoV-2 and develop innovative medicines to address current and evolving unmet needs in other viral infectious diseases,” said Hugo Fry, a former Sanofi executive who is CEO of RQ Bio.

“By combining our expertise and innovative excellence in core areas, we have created a smarter approach to antibody generation, making us uniquely positioned to deliver fast patient impact,” Fry said in a news release.

The agreement gives AstraZeneca an exclusive worldwide license to develop, manufacture and commercialize mAbs against SARS-CoV-2.

“The COVID-19 pandemic has changed the landscape for immune therapies, including the use of monoclonal antibodies to protect vulnerable patien…

Read more
  • 0

Lilly to supply up to 600,000 doses of investigational COVID antibody to U.S. government

Monoclonal antibodies were one of the first weapons to emerge in the battle against COVID-19, but only a single antibody therapy, sotrovimab from Vir Biotechnology and GSK, retains potency against the omicron variant. Two weeks ago, FDA recommended limited use of Eli Lilly’s (NYSE:LLY) bamlanivimab and etesevimab and Regeneron’s (NSDQ:REGN) REGEN-COV (casirivimab and imdevimab), given their diminished protection against omicron.

Eli Lilly, however, said it has found its investigational antibody bebtelovimab retains full neutralizing activity against the variant based on pseudovirus and authentic virus testing.

Lilly also noted that the antibody retains neutralization against the BA.2 subvariant.

Now, the company has reached an agreement with the U.S. government to supply up to 600,000 doses for a price tag of at least $720 million. The supply agreement asks for delivery of that number of doses by March 31. The U.S. has the option of purchasing an additio…

Read more
  • 0

Lonza bolsters drug manufacturing services in Switzerland

Contract development and manufacturing organization Lonza has announced a series of expansion projects during the pandemic. Most recently, the Basel-based company revealed plans to expand its drug product manufacturing services on its home turf in Switzerland.

Included in the expansion will be an installation of a new aseptic fill and finish line in the city of Stein in northern Switzerland. The filling line will enable the company to process various drug types such as monoclonal antibodies, bioconjugates and viral vectors. The company aims to finish the expansion by 2023.

The company is also beefing up its drug product services in nearby Basel. Specifically, its investments in Stücki Technologiepark in Basel will increase its offerings for early and late clinical stages. The expansion will also add to its capabilities related to integrated drug substances and drug products. Lonza aims to finish this expansion in 2024.

In late August, the company unveile…

Read more
  • 0

Regeneron exec shares how Ebola inspired COVID-19 treatment

The speed that pharmaceutical companies developed COVID-19 treatments and vaccines was “seemingly miraculous,” said Dr. George Yancopoulos, co-founder of Regeneron (NSDQ: REGN), in remarks when receiving a Titans of Global Health award.

“But these miracles were actually born many decades earlier,” he said at the virtual event ceremony from the American Friends of the Hebrew University.

NIAID director Dr. Anthony Fauci and fellow Regeneron co-founder Dr. Leonard Schleifer also were honored at the event. 

Scientists had been working on mRNA on vaccines for more than a decade before the emergency use authorizations of COVID-19 vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE). “Similarly, the technologies we use to develop our REGN-COV2 antibody cocktail were not available 10 or 20 years ago,” shared Yancopoulos, who is currently president and chief scientific officer of Regeneron. “We had to invent them and perfect them.” 

The antibody treat…

Read more
  • 0

FDA nixes EUA for Lilly’s bamlanivimab

On April 16, Lilly announced that it was requesting FDA to revoke the emergency use authorization (EUA) for the monoclonal antibody bamlanivimab (LY-CoV555) when used alone.

Hours after, the agency agreed to rescind the EUA on the grounds that bamlanivimab is potentially ineffective against some SARS-CoV-2 variants.

Bamlanivimab, however, won’t be disappearing as a COVID-19 treatment but will be paired with another monoclonal antibody known as etesevimab.

Get the full story from our sister site, Drug Discovery & Development.

Read more
  • 0

U.S. government classifies threat levels of SARS-CoV-2 variants

Image courtesy of Wikipedia

The number of SARS-CoV-2 variants with enhanced transmissibility and resistance to antibodies is increasing, prompting the U.S. government to issue guidance on how to classify them.

The criteria divide variants into three categories including the following:

Variant of interest: This virus type has genetic markers that have been linked to a potentially increased risk. Examples include mutations that could change how the virus enters cells and responds to antibodies from vaccination or infection. Such a virus could also potentially enhance transmissibility or disease severity. Variant of concern: This class includes variants with evidence of increased transmissibility, severe disease or reduction in neutralization by antibodies from infection or vaccination. Such a variant may also pose a higher risk of eluding testing. See the table below for examples. Variant of high conseque…
Read more
  • 0

Lilly’s bamlanivimab and etesevimab cut COVID-19 hospitalization and deaths in study

A recent Phase 3 trial found that bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) administered jointly led to an 87% reduction in hospitalization and deaths in high-risk patients recently diagnosed with COVID-19.

The randomized, double-blind, placebo-controlled trial administered 700 mg of bamlanivimab (LY-CoV555) and 1400 mg of etesevimab (LY-CoV016) to 511 patients in the treatment arm. FDA granted emergency use authorization to the dosing regimen, which is also supported by the European Medicines Agency’s Committee for Medicinal Products for Human Use. A total of 258 patients in the cohort of the BLAZE-1 study received a placebo.

There were no deaths in the treatment arm but four deaths in the placebo arm. All of the deaths were considered related to COVID-19.

The BLAZE-1 trial has been ongoing for several months, giving Lilly the ability some indication that its monoclonal antibodies are effective against a range of SARS-CoV-2 varia…

Read more
  • 0