Joseph Kim Inovio, President, February 20 <뉴스1> Hosted by The BioLeaders Club 2020 held at Lotte Hotel in Central Seoul, the company is presenting the theme of “Strategies for The Development of New Infectious Diseases.” 2020.2.20/News1 ©News1
New coronavirus infection (Corona 19) is entering the fifth month after it was first discovered in Wuhan City, Hubei Province, China, and domestic and international companies that have jumped into the development of new drugs are increasing.
It is a view that the atmosphere is completely different from the situation in which many companies have been put on hold in development, such as in the past, such as the “Sars” (Severe Respiratory Syndrome) and Mers (Middle East Respiratory Syndrome) epidemic. Sars has already stopped trending, and mers are also a major reason for its ability to continue research and development in terms of revenue.
However, in the case of “Corona 19”, which has a very large propagation power, the possibility of establishing itself as a seasonal epidemic infectious disease is likely to increase, and this time, it is analyzed that there will be more companies completed research and development.
According to the 18-day bio-industry, the new drug development platform technology that these companies have proposed is diverse, such as antibodies and DNA (genes), chemical synthesis. It is evaluated that a full-fledged boulder screening has begun because it is currently undergoing clinical trials through new drugs made with each technology.
◇Gilliard Remdesivir is expected to be released in the year ahead, and the new drug for treatment with the fastest clinical rate is Remdesivir, a multinational pharmaceutical company based in the United States. Although no specific research data has yet been released that could be approved as a new drug, the results of the study, which have been published sporadically to date, are encouraging. If the safety and efficacy is already being carried out in the final phase of clinical phase 3, it may be possible to obtain a year-round permit.
Gilliard’s self-synthesized nucleotide analog antiviral substance “Lemdesivir” is undergoing a number of clinical trials, including multi-country clinical phase 3. Researchers from all over the world are also conducting their own research trials of Lemdesivir.
Korea is also included in the multi-country clinical phase 3 progress, which is used by some confirmers. Currently, two clinical phases are being conducted in Gyeongbuk University Hospital, National Central Medical Center, Seoul Medical Center, etc. by severe and moderate confirmed persons. The clinicians were approved by the Food and Drug Administration on March 2 at the same time. In addition, a separate clinical phase 3 phase has been approved and implemented on March 5 by Oh Myung-don, professor of infectious internal medicine at Seoul National University Hospital.
In the process, positive clinical results were released in the United States on 16 June (local time) to draw attention. The U.S. medical magazine Stats News reported that most of the patients in patients in Corona 19 were discharged from the hospital six days after the “Remdesivir” medication, which was significantly relieved of fever and respiratory symptoms, according to a clinical phase 3 study conducted at the University of Chicago.
The clinical trial is conducted for 125 patients, including 113 patients with corona 19. Researchers at the University of Chicago reported that most of the fever dropped rapidly when patients with high fever were given the drug, and some patients who were wearing ventilators were able to self-breathe within one day of dosing. Most were discharged for six days, and only three people needed more treatment. The death toll was only two.
However, this clinical study is not a comparison between Lemdesivir and the placebo group, so it is difficult to draw conclusions about the therapeutic effect, explains Kathleen Mullane, professor of infectious diseases at The University of Chicago. Furthermore, the results of the University of Chicago Hospital is published among the clinical trials that are being conducted in various clinical institutions, so the data is insufficient. This clinical trial appears to be a clinical phase 3 for severe confirmors that are also underway in korea.
According to the Financial Times, Gilliard issued a statement on the day, explaining, “While this clinical result is encouraging, there is no statistical verification necessary to reveal the safety and efficacy of Remdesivir.” In order to finally confirm the clinical results, all clinical data results must be compiled.
The multi-country clinical phase 3, which compares the placebo group to the “Lemdesivir” dosing group, is being conducted separately for moderate confirmors. Similarly, in Korea, we are evaluating the safety and antiviral activity between “Lemdesivir” and “standard therapies” in progress. The results of these clinicians are expected to be announced in the first half of the year. If the therapeutic effect and safety are proven, it is expected that as soon as the situation is in an emergency around the world, a permit will be granted as soon as possible.
◇Therapeutic scan, vaccine, inovio Support for research by the Centers for Disease Control
The National Institutes of Health, the Centers for Disease Control and Prevention, has decided to actively support development research with Celltrion and Inovio as companies that may soon be clinically available or likely to be effective.
The National Institutes of Health recently worked with Celltrion, which was selected for an emergency research competition, to obtain 38 antibody candidates that could be therapeutically effective from the blood of the corona 19 confirmer. Celltrion screened ‘corona 19’ virus and 106 antibodies showing a good binding force as a result of investigating the degree of incapacitating the virus, 38 species showed excellent ability antibodies.
The government aims to enter clinical trials within the year for these antibodies, and expects to release products that can be used for treatment in 2021 as early as 2021.
The government also agreed to support the development of the Corona 19 DNA vaccine, which is promoted by Inovio, a U.S. biotech company.
Inovio’s new drug “INO-4800” is the fastest development axis among vaccine development companies worldwide. In particular, if only about one type of dosing is being developed so that both prevention and treatment is more attention-intensive.
According to the World Health Organization, while many companies have jumped into the development of vaccines, INO-4800 is one of three vaccine candidates in the world that have been on the clinical development track to date. The other two are China’s CanSino Biological Inc., which is developing vaccines using the ‘adenovirus’ vector. And moderna, an American company that utilizes mRNA.
In this regard, Kwon Jun-wook, deputy director of the Central Defense Prevention Headquarters, said on 16 July, “The National Institute of Health plans to work with the International Vaccine Research Institute, an international organization, to conduct research on the first and second phases of clinical trials of corona 19 vaccine candidates in korea.” “INO-4800” has already been in clinical trials in the United States since June. The government predicted that clinical trials will begin in June in Korea due to multi-country clinical trials.
Korea Clinical Phase 1 will be inoculated with 40 healthy adults, analyzing and evaluating safety, and will continue clinical phase 2 with 160 people, including the elderly. Korea’s Clinical Research Agency, the Infectious Disease Innovation Coalition (CEPI), provides $6.9 million (approximately KRW 8.4 billion). Innovio plans to apply for commercial license after completing phase 2 of clinical trials.
Innovio is developing a vaccine through the “DNA vaccine” platform technology. This technique is a small circular gene in the ‘plasmid’ in some genes of the ‘corona 19’ virus and inserted together a ‘transcription factor’ to express it as a protein (antigen) and then injected it into the body to activate the immune T cells. Immune T cells are considered to be the most powerful weapon of the body’s immune cells. Therefore, it is expected that the “preventive” effect and the “therapeutic” effect of activating the immune cells to attack the virus even after the virus infection is injected into the body in advance.
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