Who will succeed in COVID-19 treatment?

Remdesivr entered Phase III clinical trial

Competing for their mechanism among natural antibody re-infusion·genetic manipulation·chimeric DNA

As pharmaceutical companies around the world are plunging into the development of vaccines and treatments for COVID-19 treatment, attention is focused on who will succeed in commercialization.

 

Among the treatments, Gilead Sciences entered Phase III of clinical trials, and in the field of vaccines, it entered Phase I by Moderna Therapeutics.

 

However, it is not the first to release it because it may fail clinically.

 

Among the other candidates that follow, the mechanism is slightly different, and it is also a concern that they may be able to get the title of a COVID-19 treatment or COVID-19 vaccine.

 

▲Treatment = Pre-Clinical ~ Phase III There are two ways to respond to the COVID-19.

 

There is a 'therapeutic agent' that suppresses the proliferation of the virus after infection, and there is a 'vaccine' that focuses on preventing infection.

 

COVID-19 is a type of RNA virus that shares its roots with SARS and MERS.

 

A similar principle is that previously used Ebola treatments are used to treat COVID-19.

 

#Remdesivir, an Ebola treatment that Gilead Science is developing, has a mechanism to inhibit RNA polymerase necessary for virus replication and proliferation.

 

It is for this reason that it quickly entered phase III clinical trials.

 

On the 26th of last month, Gilead started phase III of Remdesivir in the United States and China, followed by investigational new drug application on the 2nd of this month in Korea and completed clinical preparation.

 

In fact, Seoul National University Hospital on the 9th concluded a clinical research agreement with the National Institutes of Health and started enrolling patients immediately from this day, so it is expected that the results will be confirmed in the first half of this year.

 

The main goal is whether to lower the boby temperature and get cured within two weeks at the same time.

 

However, it is still unknown whether Ebola virus clinical trials will lead to commercialized products in that it failed with a high mortality rate compared to competing drugs.

 

The rest of the treatment remains in the Pre-Clinical, except that Remdesivir is in Phase III clinical trials.

 

This means that it takes at least one or two years to confirm the reality.

 

Johnson & Johnson is approaching COVID-19 as a treatment and vaccine development based on its past experience in developing Ebola and Zika viruses.

 

Johnson & Johnson is developing a virus-inactivating vaccine at the preclinical stage, and is also working with the Biomedical Advanced Research and Development Authority (BARDA) to develop therapeutics for patients who are already infected.

 

Through this, it is examined whether existing medicines, such as Remdesivir, an Ebola treatment, Kaletra, an AIDS treatment, and Avigan, a flu drug developed in Japan, are effective in suppressing COVID-19.

 

US bio-company Regeneron Pharmaceuticals is focusing on the development of antibody therapeutics through genetic engineering.

 

Although it is still in the preclinical stage, Regeneron plans to develop an antibody therapy against COVID-19 through mouse genetic manipulation technology capable of producing human antibodies.

 

The candidate is expected to go into animal testing soon, and is preparing for human clinical trials by the third quarter of this year.

 

In fact, during the Ebola incident in 2015, Regeneron had experience in developing a mixed-antibody drug that doubled the patient's survival rate.

 

Vir Biotechnology is also developing antibody-based therapeutics.

 

The difference from Regeneron is that instead of generating antibodies by genetic manipulation, antibodies that are naturally produced after infection with similar corona-like viruses such as SARS in the past are used.

 

In fact, this method has been applied to MERS and SARS in the past.

 

A method of collecting serum from a patient who formed a natural antibody and administering it to a serious patient was achieved.

 

Vir Biotechnology is investigating whether the SARS virus is similar to COVID-19, so that antibodies from patients recovering from SARS can be isolated and applied to COVID-19.

 

#Vir is in the early stages of development in cooperation with Chinese company WuXi Biologics, and it is not clear when the clinical trial is expected.

 

▲Vaccine = Pre-Clinical ~ Phase I Currently, phase I is at the forefront from vaccine development.

 

Modena therafutics developed the vaccine candidate mRNA-1273 only 42 days after the nucleotide sequence of the COVID-19 was confirmed and jumped to the promising group.

 

mRNA has a mechanism in the body that allows cells to form antibodies on their own.

 

Modena is expected to begin research next month with healthy volunteers in cooperation with the National Institutes of Health (NIH).

 

Once the safety of mRNA-1273 has been demonstrated, Phase II will be undertaken to confirm the effectiveness of the vaccine in hundreds.

 

However, Modena, which is developing mRNA or mRNA designed for cells in the body to produce antibodies against viruses, has not been approved by the FDA as a related drug.

 

Except for Modena, vaccines of various mechanisms are still in the Pre-Clinical.

 

CureVac, like Modena, develops a vaccine that promotes the production of antibody proteins using synthetic mRNA.

 

It is expected to be ready for clinical trials within a few months.

 

China's Clover Biopharmaceuticals, was transferred its technology to a proprietary adjuvant compound that improves the effectiveness of the vaccine from GSK in February and started developing vaccines.

 

The company is developing a vaccine against infection by injecting a protein that stimulates the immune response and activating body immunity, but the clinical trial plan has not yet been detailed.

 

Inovio, the United States, has been developing DNA medicines for the past 40 years, and has received subsidies for the development of DNA-based vaccines from the Coalition for Epidemic Preparedness Innovations (CEPI).

 

In partnership with Chinese manufacturer Beijing Advaccine Biotechnology, INO-4800 candidate vaccine is in Pre-Clinical, and clinical trials are expected in the second half of this year.

 

Sanofi, which has successfully developed a yellow fever and diphtheria vaccine, is working with the BARDA to develop COVID-19 vaccine.

 

Sanofi aims to create a chimeric DNA vaccine that activates the patient's immunity by mixing a portion of the DNA of COVID-19 with the genetic material of the harmless virus.

 

The vaccine candidate is expected to be tested in the laboratory within 6 months, and the clinical trial is expected to be available within 1 to 18 months.

 

Sanofi said the technology has been applied to SARS.

 

However, Sanofi expects to take at least three years to get approval.

 

Experts say it is too early to make a positive outlook, as various therapeutics and vaccines are still in the Pre-Clinical of exploring candidates and evaluating safety.

 

Professor Ki-seok Jeong of the department of Pulmonology at Hallym University said, "I think it is difficult to cure the drug in the near future.

 

However, in the case of Remdesivir, an ebola drug, it would be better if indications were added as much as it promotes clinical trials in Korea".

 

"An RNA virus has many mutations, so it is not easy to develop a therapeutic drug and it is more difficult to develop a vaccine.

 

Considering that multinational companies spend ￦1 trillion on new drug development, a government-level investment in development is necessary" he advised.