Ineffective against mutant strains, Eli Lilly’s double antibody therapy was stopped

[Text/Observer Net Tao Meng, Zhou Yi, Editor/Zhou Yuanfang]

Because of its ineffectiveness against some mutant strains, Eli Lilly’s "dual antibody therapy" was temporarily suspended in the United States
.

As a joint research and development party of one of the antibodies, Shanghai Junshi Biotechnology issued a clarification announcement today (28th) to explain the matter.

In the afternoon of the same day, Zhao Deyun, co-editor of Metz Medical/ Biological Valley, accepted an interview with Observer on this topic
.

Eli Lilly's new crown double antibody therapy is stopped, does not mean that antibody therapy is not feasible

Bio Valley

Picture source Eli Lilly company website

Picture source Eli Lilly company website

"May not provide people with protection against these two new coronavirus mutant strains"

"May not provide people with protection against these two new coronavirus mutant strains"

On June 25, the US health department suddenly announced that it would stop distributing Eli Lilly’s 1400mg etesevimab (JS016) and bamlanivimab (bamlanivimab, LY-CoV555) 700mg new crown double antibody therapy (hereinafter referred to as "Double antibody therapy") until further notice
.

The reason is that the US Centers for Disease Control and Prevention (CDC) has detected the P.
1/Gamma mutant (Gamma variant virus, first confirmed in Brazil) and B.
1.
351/Beta mutant (Beta variant virus, first in South Africa).
Confirmed) The total proportion in the United States has exceeded 11% and is on the rise
.

The results of in vitro analysis showed that Etesvizumab and banivirimab were not effective against the above-mentioned two virus mutant strains

This means that "dual antibody therapy" may not provide people with protection against these two new coronavirus mutant strains
.

Therefore, the US Department of Health recommends that healthcare providers across the country use other monoclonal antibody therapies, including Regeneron’s REGEN-COV and GlaxoSmithKline’s sotrovimab
.

Today (June 28), the Institute of Microbiology of the Chinese Academy of Sciences jointly developed esvirizumab and authorized the rights of the antibody outside the Greater China region to Eli Lilly’s Shanghai Junshi Biologics.
A clarification announcement was issued in response to the suspension.
The supply of "diabody therapy" is not withdrawing its emergency use authorization (EUA) in the United States
.

Previously, the "double antibody therapy" by the US Food and Drug Administration in February Management Authority ( the FDA ) emergency use authorization

Clarification announcement governs FDA

Junshi Bio also stated that according to the paper Tackling COVID-19 with neutralizing monoclonal antibodies published in the internationally authoritative academic journal "CELL" in June 2021 , the "dual antibody therapy" targets the B.
1.
1.
7/Alpha mutant.
(Alpha mutant virus was first confirmed in the UK and currently accounts for about 60% of SARS-CoV-2 in the United States) and B.
1.
617.
1 mutant (Kappa mutant virus, first confirmed in India) are both effective
.

In the past few months, the proportion of the mutation types of the new coronavirus in various regions of the United States has changed rapidly.

COVID-19

However, Junshi Bio also emphasized in the announcement that the supply of diabody therapy is related to the development of the U.
S.
epidemic and the approval of relevant regulatory authorities.
There is a high degree of uncertainty in its subsequent changes, and the impact on the company's future performance is also uncertain
.

Pharmaceutical products have the characteristics of high technology, high risk, and high value-added.

Subsequently, Junshi Biotechnology Innovation Board and Hong Kong stock prices were affected
.

In this afternoon, both Junshi Biotech's A shares and H shares fell sharply.

After pressing the "pause button", where is the way?

After pressing the "pause button", where is the way?

Zhao Deyun, co-editor of Metz Medical/Biological Valley, told Observer.
com that there is no specific medicine for the treatment of new coronary pneumonia , and clinical treatment methods are different depending on the condition
.

The suspension of the new crown double antibody therapy does not mean that "there is no way

Coronavirus disease

In addition to the increase in Gamma variant virus and Beta variant virus infections , Delta variant strain infections in the United States are also on the rise
.
In vitro studies have shown that this "dual antibody therapy" is currently unable to provide effective treatment for new variant strains
.
But for early Alpha variants, the therapy is still effective
.
With the emergence of new mutant strains one after another, whether the existing antibodies and their combination therapies are effective against the new mutant strains still needs further observation and research
.

Infect

It is worth adding that the Delta Plus variant (ie "Delta+", B.
1.
617.
2.
1 or AY.
1) formed by further mutation of the Delta variant virus is gradually arousing people's vigilance
.
It has a mutation in the spike protein called K417N
.
India’s top virologist Shahid Jameel once mentioned that K417N reduces the effectiveness of therapeutic monoclonal antibody mixtures, and has been found in Beta and Gamma variants
.
The New Crown Genome Sequencing Agency of the Government of India stated that Delta Plus is more communicable, binds to lung cell receptors stronger, and also brings potential reduction in antibody response
.

"At present, there is no specific fixed therapy for the treatment of
COVID-19 in clinical practice.
Combination therapy is the future direction .
" Zhao Deyun pointed out that depending on the condition, there may be both antibody therapy and other antiviral and anti-inflammatory treatments, including oxygen support.
Symptomatic treatment"
.
There may be some new drugs in the future, but due to the slow progress of their research and development, immunotherapy is still a general direction, and antibody therapy is still a more effective way
.
The more ideal future is the "multi-antibody" therapy: a certain antibody or a certain group of antibodies is not effective, and another antibody is mixed to produce a new "combined antibody", which may still have a strong virus neutralization effect
.

immunity

Recently, an in vitro experimental study conducted by the University of Washington based on Eli Lilly, Regeneron, AstraZeneca, GSK and other companies verified this point of view: a combination of antibodies against the new coronavirus made from two antibodies, even if one of the antibodies has been lost The ability to partially or completely neutralize the mutant strains, and the combination antibody therapy (even if the dose is relatively low) can still maintain the efficacy of treating the mutant strains
.

"Double antibody therapy" was pressed the "pause button"
.
Editor-in-chief Zhao Deyun said that while it is "ineffective" against some emerging virus variants, it may still be effective against other mutant strains
.
It should be pointed out that its emergency use authorization (EUA) has not been revoked, and it is unlikely to be revoked.
Instead, it is possible to resume the supply of the therapy combination
.

"When a treatment method fails, people will explore new methods
.
People will try a combination of different antibodies, or they can be further transformed into an "enhanced" neutralizing antibody therapy based on the original antibody therapy, so that it has more "Broad-spectrum" efficacy
.
The virus is actually fighting against humans, and it will also produce a certain degree of drug resistance.
Our antibody treatment strategy will also change accordingly
.
In the future , we may pay more attention to drug resistance.
If the epidemic does not get If it is well controlled, the new coronavirus will have continuous new mutations, which will bring more new challenges.
We must continue to monitor the effectiveness of antibody therapy
.
Combination therapy may be required to deal with the new coronavirus infection .
"

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