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  • CEO Kim Yong-sang of Repure Life Science -

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  • 2020-09-18
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"Differentiated from other treatments... Securing neutralizing antibody protein sequence this year-Development in the second quarter of next year" 


With the rapid spread of COVID-19 around the world, governments and pharmaceutical and bio companies are actively developing COVID-19 vaccines and treatments. Among them, the development of a therapeutic agent using plasma of a cure for COVID-19 is drawing attention.

 

Repure Life Science, Yonsei University Severance Hospital, and Kyungnam Biopharma started a joint research aimed at developing COVID-19 antibody treatments on June 10th. According to them, this plasma-derived antibody treatment differentiates it from other COVID-19 treatments.


Repure Life Science CEO Kim Yong-sang (photo) said, “The antibody treatment to be developed is a highly efficient treatment because it is developed by mass-producing and selecting neutralizing antibodies in the plasma of cured patients through the officially known antigenic proteins of SARS-CoV-2 and immunoprecipitation. We are looking forward to developing it.” We introduce interview of CEO Yong Sang Kim about the antibody treatment being developed.


∆ Among the treatments for COVID-19, treatment using ‘plasma’ is often discussed.


- As a treatment using plasma, there is a kind of medical practice in which blood plasma in the recovery period of the cured person is directly transfused into COVID-19 infected patients as component blood donations. In April, Prof. Jun-Yong Choi's team at Yonsei University Severance Hospital confirmed the effectiveness of treatment using plasma from recovered patients for two severely ill patients with COVID-19, and on the 23rd (local time), the US FDA urgently approved on the use of plasma treatment for COVID-19 patients.


However, treatment with plasma is difficult to prove safety. Providing alternatives to potential risk factors implicated in plasma, e.g. careless transmission from other infectious agents, allergic reactions, thrombotic complications, blood transfusion-related circulatory overload, transfusion-related acute lung injury (TRALI), antibody-dependent infection enhancement, etc. Not only is there a problem with the movement of blood products between countries, but also the fact that there are no drugs approved for blood products within the FDA is an obstacle.


In fact, even in the case of a blood treatment drug that was urgently approved by the U.S. FDA, the clinical evaluation of the FDA was not completely performed, and the effectiveness was confirmed only in 20,000 out of 70,000 patients among experts, so whether the potential benefit from this outweighs the potential risk? Opinions are divided.


Accordingly, several treatment companies have begun developing “plasma treatment” using therapeutic substances that exist in plasma beyond simple “plasma treatment”. 'Plasma treatment' is a drug whose efficacy and safety have been confirmed through elaborately designed clinical trials unlike simple plasma administration. In the case of simple plasma administration, about 500ml of plasma should be administered to treat one patient with COVID-19 infection, which requires cured plasma from two or three recovered patient.


However, plasma treatments can be produced on a large scale because the treatments are developed using plasma from recovered patient COVID-19.


'Plasma Fractionation Treatment', one of the plasma treatments using plasma, is a method of injecting hyperimmune globulin made from only the immune protein in the plasma of recovered patients from COVID-19. Korean company G is developing a plasma fractionation treatment, and is currently developing it with the goal of completing the phase 2 clinical trial by the end of this year with approval for phase 2 clinical trial.


∆ What is an antibody treatment


-Another method besides plasma treatment, 'antibody treatment', is a method of extracting antibody-producing B cells present in the plasma of recovered patient to obtain a gene sequence that can make neutralizing antibodies, or to develop a treatment by selecting neutralizing antibodies in plasma.


Representatively, R, a global pharmaceutical company in the United States, entered phase 3 clinical trials in June with a combination treatment of two antibodies, and Company ‘I’ in the United States developed an antibody treatment with the National Institute of Allergy Infectious Diseases (NIAID) and ‘A’, a Canadian bio company, in July. I entered a phase 3 clinical trial. As for domestic companies, “Kyungnam Biopharma/Repure Life Science” and Company ‘C’ are developing antibody treatments.


∆ Antibody therapy development proceeds in some way, and the difference between ‘Repure Life Science’

-In general, when developing antibody therapeutics, B cells (white blood cells that produce antibodies) are detected in the plasma of the person who healed, and then the genetic information that produces antibodies is extracted from them. Antibody candidates are selected based on the obtained genetic information, and neutralizing antibodies with high effectiveness are screened/secured through double neutralization testing.


However, the antibody treatments developed by Repure Life Science/Yonsei University Severance Hospital/Kyungnam Biopaga are primarily effective in neutralizing antibodies present in the plasma of the recovered  person through a neutralizing ability test, and then the plasma with high neutralizing ability is selected. SARS-CoV-2 (Coronavirus) antigen protein is used to secure neutralizing antibodies. In addition, we take a differentiated strategy to develop as a COVID-19 antibody treatment by securing the protein sequence of the obtained neutralizing antibodies.


In addition, most of the researches on developing neutralizing antibodies mainly use Spike protein, one of the surface proteins of SARS-CoV-2, as an antigen. Spike protein is an outer dendritic protein of SARS-CoV-2 that binds to the host cell surface receptor ACE2 (Angiotensin Converting Enzyme2) and allows the virus to penetrate into the host cell. Therefore, we are trying to develop a neutralizing antibody that can inhibit the binding of the virus's spike protein to the host cell's ACE2 receptor.


∆ Current progress


-Repure Life Science does not use only the spike protein of SARS-CoV-2 as an antigen, but with the envelope protein, which is the structural protein of the remaining COVID-19virus, and membrane glycoprotein (which is involved in the formation and release of viral particles). Membrane glycoprotein; embedded in the lipid bilayer membrane of the virus and wrapped around a helical nucleocapsid protein), Nucleocapsid protein; a COVID-19virus genetic material, RNA single strand (ssRNA) and an unstable RNA genetic material surrounding it It uses both HE protein (Hemagglutinin-esterase dimer protein; an important role in viral host cell surface adhesion and release process) as antigens to detect neutralizing antibodies in plasma of COVID-19 patients. Use.


Therefore, it has a plan to develop a more effective antibody treatment, leaving the possibility of detecting all neutralizing antibodies that can neutralize the COVID-19virus with another action as well as neutralizing antibodies targeting the virus's spike protein.


In addition, since antibody therapeutics are developed targeting all of the structural proteins of the virus, it is expected to be able to flexibly cope with various strains of COVID-19virus such as S, V, L, G, GH, and GR, so a wider range of COVID-19 infected patients I think it can be applied to.


Developing therapeutic substances in a differentiated way from the existing one can be said to be a valuable research approach that can enable the development of new and flexible therapeutics for the outbreak of new infectious diseases in the future. Developing new drugs with such diverse and differentiated research methods is an advantage and reason for existence as a bio venture company.


∆ Future development schedule and plan


-As a result, we aim to secure the protein sequence of COVID-19 neutralizing antibodies within this year and complete the development of antibodies for COVID-19 treatment within the second quarter of 2021.


In addition, Repure Life Science will prepare for domestic phase 3 clinical trials for vaccines that have already passed phase 1 and 2 clinical trials abroad and entered phase 3 clinical trials, and will use samples collected from the oropharynx, nasopharynx and sputum. We are planning to develop an in vitro diagnostic kit for COVID-19 that can quickly diagnose Coronavirus infection with fluorescence immunity.


Antigen diagnostic kits have very high sensitivity and specificity, and have the advantage of being able to diagnose very quickly compared to diagnosis by genetic testing using existing RT-PCR technology. Repure Life Science in vitro diagnostic kit is a study on the development of antibodies. We plan to develop using the results.


Through this, Repure Life Science is expected to possess all technologies that can encompass both prevention, diagnosis, and treatment of COVID-19 in the future.


In addition, as a new drug development bio-venture company that develops therapeutic antibodies and new therapeutic substances to treat incurable diseases such as cancer and fibrosis, we are currently developing monoclonal antibodies for treatment targeting new intractable cancer target proteins. In addition, the molecular mechanism that induces refractory fibrotic diseases in tissues such as lungs, liver and kidneys has been identified using epigenetic research methods, and new treatments for fibrotic diseases using novel specific inhibitors are also being developed.