The world’s first antibody therapy begins clinical trials

The world’s first potential antibody therapy against novel Coronavirus has entered human clinical trials, which may be the best hope before the novel coronavirus vaccine.

On June 2, Beijing time, Eli Lilly & Company (” Lilly “) announced that its major antibody, Ly-COV555, developed in collaboration with Canadian biotechnology company AbCellera (” AbCellera “), has entered phase 1 human trials.

Source: Visual China

A phase 1 clinical trial of the antibody therapy is currently under way at medical centers in New York City and Los Angeles, with results expected by the end of June.

Lilly said that if it can demonstrate good safety and tolerance, it plans to expand the trial to novel Coronavirus patients who are not inpatient or infected with the virus.
If the trial is successful, the treatment is expected to be rolled out in the autumn.

After the announcement, LILly rose 0.92 percent to $153.86 per share on June 2, and continued to rise to $155.45 per share before time Went to press.

Chen Ren, director of the Infection department of Guangdong Provincial People’s Hospital, told Time Financial on June 2 that antibody drugs are expected to be used for coVID-19 treatment and prevention before the arrival of coVID-19 vaccine, but the effectiveness and side effects of the research and development process need to be further improved.

The first novel coronavirus drug to enter the clinic

In fact, antibody therapies designed to “neutralize” the coronavirus are considered by many scientists to be the most promising drugs.

Neutralizing antibodies are therapeutic antibodies that protect cells from being damaged by neutralizing or inhibiting the biological activity of pathogens, Chen told Time Financial.
“In the absence of coVID-19 specific drugs and vaccines, the development of antibody drugs will play an important role in the treatment and prevention of coVID-19.”

The “protagonist” of this clinical experience so far, the antibody LY-COV555, was identified from the first north American blood samples from coVID-19 survivors.
According to AbCellera’s website, LY-COV555 is a highly effective neutralizing monoclonal antibody against IgG1. Its mechanism of action is to prevent and treat COVID-19 by preventing the virus from attaching to and entering human cells and neutralizing the virus.

When novel Coronavirus invades the cell, the thorn protein (S protein) binds to ACE2, the surface receptor of human cells, and then the virus is internalized, enters the cell, replicated by transcriptase in the cell, and reassembled into a large number of new viruses, which continue to infect other cells, thus invading the human body.

Based on this, blocking the binding domain of virus surface receptor and cell surface receptor becomes an idea to develop antiviral drugs.

So far, doctors at NYU Langone Health have administered intravenous injections to the first study participants.

If the results of the phase 1 study show that the antibody is safe to use, the next phase of the test will be conducted to test the efficacy of LY-COV555 in non-inpatient coVID-19 patients.
Lilly also said it would study the drug in a preventive setting, focusing on vulnerable groups of patients.

“Antibody therapies such as LY-COV555 may have dual potential to prevent and treat COVID-19, and may be of particular importance to populations most affected by disease, such as the elderly and those with compromised immune systems,” said Dr. Daniel Skovronsky, Chief Scientific Officer of Eli Lilly and President of Lilly Research Laboratories.

The side effects of antibody drugs are still unknown

Neutralizing antibodies are different from vaccines, which use an antigen to induce antibodies in the body. Neutralizing antibodies are treated by direct injection.

To jen, although antibody development time is short and the curative effect is rapid, but now will be coronavirus understand phase, is still in antibody therapy there are a lot of security problems, “such as plasma treatment, after high-profile survivors, the person that weigh in at first will be used for the treatment of patients with, not only has the will but survivors plasma antibodies against coronavirus, there are other antibodies and proteins, are injected directly into the body, easy to cause allergies, shock, etc.”
Jen said.

Director of Beijing’s people’s liberation army (PLA) 302 hospital infection branch clinical Lin Yi also told The Times of finance and economics (a pseudonym), in addition to the potential unsafe factors, plasma treatment is based on past experience, survivors for plasma using dosage and the effect of the antibodies in plasma was not exact data, so that not enough progress has been made in many patients after injection of convalescent plasma effect.

In Lin’s opinion, the research and development of antibody drugs should not only break through the safety and effectiveness, but also follow the rules of scientific research and development, which requires a long clinical trial process.

Time Finance learned from a researcher in a third-grade A hospital in Guangzhou that the hospital had previously tried to develop a study on novel Coronavirus antibody therapy, but the study “died young” due to a series of side effects.
“The study of antibody drugs is not complicated in theory, but in practice it exposes many problems, such as the body’s allergy to protein, the effect of antibody injection on patients and so on, which is a very large project,” the researcher said.

According to Lilly, the trial will begin mass production while studying the safety and effectiveness of the LY-COV555.

Daniel Skovronsky says that if ly-COV555 is part of the immediate solution, hundreds of thousands of doses are expected to be available by the end of the year.

However, time finance in a number of industry experts learned that the development of domestic and foreign antibody drugs is still in the exploratory stage, want to develop high quality, high purity antibody drugs, and achieve mass production, in the short term may be difficult to achieve.

Mass production requires sufficient antibody sources and purification, a process that is difficult to accomplish in a short time, Chen said.

Global race to develop antibody drugs

At present, there is a global race against time for the research on novel Coronavirus. There is mixed news in the field of vaccine and the research and development of antibody drugs also starts to race.

Lilly has entered into a partnership agreement with Junth Biomedical Technologies (hereinafter referred to as “Junth Biotech”) to submit another novel Coronavirus clinical trial application and initiate clinical research in the Second quarter in China and the United States.

In response to the latest development of the clinical trial, Time Finance repeatedly called jun Shi Biological Director’s office on June 3, but no one answered the phone until press time.

On May 26, the results of a preclinical study on neutralizing antibody, jointly developed by Junshi Biology and the Institute of Microbiology of the Chinese Academy of Sciences, were published online in the journal Nature, Time Finance noted.

In this study, two novel Coronavirus (SARS-COV-2) specific neutralizing antibodies were found to have strong novel neutralizing activity, among which the antibody named CB6 can significantly inhibit virus infection in animal experiments of rus monkeys, showing therapeutic and preventive effects and having the value of clinical transformation.

Recently, xie Xiaoliang, director of the Biomedical Frontier Innovation Center at Peking University, Chen Wei, academician of the Academy of Military Medicine of the Academy of Military Sciences, zhou Qiang Laboratory of West Lake University and other teams have made certain progress in the research of neutralizing antibodies.

The research results of Xie xiaoliang’s team have been published in the international famous academic journal Cell on May 17

In addition, Lilly’s rival Regeneron Pharmuticals said it plans to begin clinical studies in June testing its antibody cocktail therapy against Novel Coronavirus, with the goal of making hundreds of thousands of prophylactic drugs available by the end of August.

Chen Ren believes that the development and production of antibody drugs cannot be separated from the cooperation of multiple forces, including human, material, financial input and policy support.

Lin yi also said that the global research on coVID-19 antibody is still in the initial stage of clinical trials, and many external factors still need to be broken through before the drug can be successfully developed and put into large-scale production. The multi-party cooperation in developing coVID-19 antibody drugs at home and abroad is expected to further improve the success rate and speed of research and development.

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