[헬스코리아뉴스 / 이순호] The era of biopharmaceuticals is fast approaching. It is a typical irony that war and infectious diseases led to the development of modern medicine and the pharmaceutical industry, but the novel coronavirus infection (COVID-19) also invariably developed the pharmaceutical industry one step further. In particular, the development of the biopharmaceutical field is continuing rapidly, and the COVID-19 messenger RNA (mRNA) vaccine is leading this.
An mRNA vaccine is a vaccine that induces an immune response by inserting a viral blueprint into the body to generate a viral protein in the body. The mRNA serves as the blueprint, and a cell organelle called the ribosome, a protein production factory, reads the genetic information of the mRNA and creates a coronavirus protein.
Since only mRNA engraved with the genetic information of the viral protein needs to be administered, there is no need to separately make the viral protein through external recombination as in the existing method. Therefore, in case of an outbreak of an infectious disease, it can respond faster than existing vaccines. Even in the current COVID-19 situation, mRNA vaccines were made and distributed first.
However, this is the first time that an mRNA vaccine has been commercialized despite these advantages. German biotech company Biontech (co-developed with Pfizer) succeeded in developing it for the first time, and American bio company Moderna succeeded in developing it for the second time.
The history of mRNA vaccine research is not long, around 10 years or so. Since there are not many development cases, verification of long-term safety is still insufficient. In particular, there is concern that when incorrect genetic information is engraved on the mRNA, which is the blueprint, a mutant protein is generated and it is not known what effect it will have on our body.
Nevertheless, COVID-19 mRNA vaccines are being vaccinated rapidly around the world. This is because the situation is urgent. As research on this vaccine has been lacking, governments and pharmaceutical companies are rushing to vaccinate mRNA and investing in follow-up research. The same goes for our country.
The government recently disclosed information on mRNA vaccine patent analysis to support drug development by domestic mRNA vaccine development companies. This report contains 691 patents derived from a comprehensive analysis of platform technologies related to mRNA vaccines and patents by company.
In particular, it has been summarized by technology from the researcher’s point of view so that researchers can easily grasp patent information related to mRNA vaccines. It is expected to serve as an important reference when developing mRNA vaccines in future companies and research institutes.
The government also launched a K-mRNA consortium with the Korea Pharmaceutical Biotechnology Association with the goal of developing a domestic mRNA COVID-19 vaccine. The consortium, in which five pharmaceutical and bio companies including Hanmi Pharm, ST Pharm, GC Green Cross, Dong-A ST, and Ecell, participated, is currently developing ‘STP2104’, a candidate mRNA for COVID-19 vaccine. The goal is to enter phase 1 clinical trial within this year and commercialize it following conditional approval in the first half of next year.
The Korea Biopharmaceutical Association and the Vaccine Safety Technology Support Center (Vaccine Center) will also launch the ‘mRNA bioventure consortium utilizing the infrastructure of the Vaccine Safety Technology Support Center’ on the 15th. In this consortium, domestic bioventures such as Curatis, Igene, Jinwon Life Sciences and vaccine producer Boryeong Biopharma will participate.
These four companies plan to utilize public infrastructure through a consortium and accelerate the development of mRNA vaccines through technological cooperation among bioventures.
Expanding mRNA technology to anticancer drugs
Indian DNA Vaccine Appears
mRNA technology is not limited to prophylactic vaccines. Recently, research has been actively conducted in the field of anticancer drug development.
Overseas, Moderna and Merck and CureVac and Biontech have joined forces with Roche and Genentech to conduct clinical research in combination with an mRNA anticancer vaccine and immunotherapy for solid cancer.
In Korea, ST Pharm and Theragen Bio started joint research and development of a neo-antigen mRNA anticancer vaccine and CDMO (consignment development and production) cooperation.
TheragenBio derives mRNA anticancer vaccine candidates through a new antigen prediction method through artificial intelligence (AI) gene sequencing, and ST Pharm has 5 prime-capping and lipid nanoparticles ( LNP) delivery platform will be provided. From clinical trials to commercialization, ST Pharm will be in charge of the CDMO of the mRNA-LNP vaccine stock solution.
The principle of the new antigen mRNA anticancer vaccine is to predict the optimized new antigen by analyzing major mutations and characteristics of cancer cell genes extracted from cancer patients. It is a method of treating cancer by inducing an immune response that responds specifically to cancer cells by administering mRNA that produces new antigens to cancer patients.
Recently, vaccines using DNA rather than mRNA have emerged. The main character is ZyCoV-D, a COVID-19 vaccine developed by Zidus Cadilla, an Indian pharmaceutical company. Recently, it received emergency use approval from the Indian government and became the world’s first commercialized DNA vaccine.
Genexine and Jinwon Life Sciences are also developing a COVID-19 DNA vaccine in Korea, but it is known that they are having a hard time recruiting clinical subjects and securing a control vaccine as vaccines are being vaccinated rapidly around the world.
Corona 19 promotes change in antibody treatment formulation
Celltrion in development of inhaled ‘Rekkorna’
COVID-19 is also accelerating the change in the formulation of antibody therapeutics. Currently, all commercially available antibody therapeutics are injections. This is the same for the treatment for COVID-19, so patients must administer intravenous administration for at least 60 minutes.
Although it is currently the only treatment method, it is compared to oral drugs that are still under development due to relatively low convenience and accessibility.
Due to this situation, pharmaceutical companies with COVID-19 antibody treatment are trying to change the formulation. Celltrion, a domestic company that independently developed the antibody treatment ‘Rekkorina’ (legdanvirab), started developing an inhaled formulation.
Last month, the company received an IND approval from the Australian Therapeutic Goods Administration (TGA) for the inhalational formulation of ‘Lekkorona’.
Inhalon Biopharma, an American bio company that has signed a contract with Celltrion and is developing an inhaled ‘Rekkorna’, will conduct this phase 1 clinical trial on 24 healthy subjects. Inhalon plans to evaluate the effectiveness of the inhaled ‘Rekkorina’ by starting a phase 2 clinical trial within the year after completing the phase 1 clinical trial.
Celltrion and Inhalon have been discussing the development of the inhaled ‘Rekkorna’ since July last year. The two companies conducted research focusing on the fact that the respiratory delivery of an inhaled drug is determined by the drug particle size, and confirmed that the aerosol particle size of ‘Rekkorina’ generated through the inhaler was suitable for respiratory delivery.
Inhaled ‘Rekkorina’ is a treatment method that delivers antibodies to the respiratory tract mucosa infected with the Corona 19 virus. As the drug is delivered directly to the lungs through the respiratory system, Celltrion expects that patients’ access to antibody therapy will be further enhanced.
An industry official said, “As biopharmaceuticals are playing a role in preventing COVID-19, it is clear that investment in related fields will be further strengthened.” “Pharma companies around the world will not want to miss this opportunity. There is a possibility that there will be a seismic change in the pharmaceutical market in the future.”
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