• E-mail: matsuda-k@mbiotech.org
• Home Page: http://www.mbiotech.org

・The research and development of treatments such as revolutionary diagnostic products and the vaccines is promoted based on pioneering finding concerning the mycoplasma lipid-antigen.

・It aims at the establishment of the overall diagnosis-treatment system, which adjusted to the whole image of the mycoplasma infectious disease clarified by a revolutionary diagnostic system.

・The exploitation technology obtained for the lipid-antigen research is assumed to be a platform technology that has generality to be applied for other microorganisms (microorganism LIPIDOMICS).

・M Bio Technology Inc. introduces the microorganism lipid-antigen analysis technology into clinical diagnosis-treatment, and is challenging overcoming the disease to which the lipid-antigen is related.

・An open innovation and the global expansion are assumed to be a schematic plan, and technological development with the university and research laboratories and the tie-up and joint developments of the diagnostic product enterprise and the medicine manufacture enterprise are promoted.

・It is assumed to be a mission to put study results of the mycoplasma lipid antigen to practical use, and to contribute to the establishment of diagnosis-prevention-treatment method of the mycoplasma infectious disease.

・It challenges the vaccine, the antibody drug, and the research for the development of new drugs based on the technology of the mycoplasma lipid antigen.

・It challenges overcoming the mycoplasma infectious disease such as not only the mycoplasma pneumonia but also mycoplasma related diseases such as asthma.

・The microorganism lipid antigen analysis technology is introduced into clinical diagnosis-treatment, and it challenges overcoming the disease to which the lipid antigen is related.

・An open innovation and global development are promoted.　

・Community-aquired pneumonia is usual pneumonia. Affects 4 million adult per year in the United State, with an Annual cost of $9.7 billion.nearly 20% of whom are admitted to a hospital for treatment. Mycoplasma occupy 15-30%. In every day practice the etiology of CAP is unknown in up to 70% of patients. Mycoplasma pneumoniae is also one of the leading pathogens causing both upper and lower human respiratory infections, in all age groups. Mycoplasma infection is realy wide-spread disease.

・About 20% of Community-acquired Pneumonia is related to mycoplasma. 1-2% of infected individual become pneumonia. Cases occur throughout the year, with epidemics every 3-5 years. 1 year old: 40％、5 years old: 65％、Adult: 97% are affected. Schools and military installations, most cases occur sporadically or in families.

・Mycoplasma pneumoniae infections is not only respiratory diseases, but also diseases of the whole body, such as Extrapulmonary manifestations: Encepharitis, Pancreatitis, Hepatitis, Dermatitis, Nephritis, Arthritis. These exreapulmonary manifestations are seen 25% of infected individual This is a example of dermatitis.

・More importantly, Mycoplasma infection sometimes associated with serious illness. It causes chronic inflammatory diseases such as asthma, rheumatic diseases, neurological disorders.

・It is important to realize the seriousness of mycoplasma infection.

・Because of the seriousness of the diseases, diagnosis and therapy become more important.

・Mycoplasma is a cause of wide-spread and serious diseases. However, there had been no good diagnostic tool and vaccine.

・The CDC says at home page, about Mycoplasma pneumonia. Incidence of each year are estimated 2 million cases and 100,000 pneumonia-related hospitalizations occur in the United States. Trend is unknown, however, with improved diagnostic testing, more cases may be identified.

・Antibiotics used to treat Mycoplasma pneumonia are different from those for other bacteria, because mycoplasmas do not have cell walls. Drug resistant mycoplasmas is increasing.It is important to develop good diagnostic tool and therapeutic tool both. However, at the present, No vaccine is available for mycoplasma pneumoni, and appearance of drug-resistant mycoplasma is realy problem clinically.

・Vaccines have been the most effective tool for preventing and eliminating devastating infectious diseases, and thus improving the quality of life.

・Their role will be increasingly important in the medicine of the future because biotechnology has now broadened the targets of vaccination to include new infectious diseases, immunotherapy of tumours, chronic infections, autoimmunity and allergies.

・In the lipid constituent of the microorganism, there is strong immunity activation revitalization such as lipopolysaccharides (LPS), lipoteichioic acids (LTA), and lipoarabinomannan (LAM). These molecules might excessively stimulate the immunological system in non-peculiarity. There is no non-peculiar, excessive stimulation from the comprehensive analysis of the lipid

・As a result, it leads to the drug development that controls the molecular mechanism and the immunity system of an important immune response for understanding the pathogenesis.

・Kazuhiro Matsuda is involved in the research of the mycoplasma lipid antigen long, and has left the research achievement of top-level in the world. For instance, when Encyclopedia of Life Science (http://www.els.net/) is retrieved on the Internet, the life science encyclopedia to which the writing charge is done is a writer in this of the retrieval of Lipid Antigen of Immunology/ Antigen and their recognition /Antigens though it comes first.

・Matsuda pays attention to the cell membrane lipid antigen of the mycoplasma, clarifies the structure of the lipid antigen in advance of the world, and has succeeded in chemosyntheses. As a result, excellent diagnostics is established, and, in addition, development with the vaccine is aimed at. This is a technology that leads to the contribution of reformative diagnosis-prevention and the treatment system of asthma, the rheumatic disease, and diseases of the nervous system to construction.

・A unique lipid antigen of the microorganism of mycoplasma becomes an important clue to develop the treatment like the condition clarification and the vaccine etc. of the mycoplasma infectious disease. This platform technology becomes a world first with the lipid antigen that becomes the world standard material. If this technology is achieved, prevention and the treatment of the mycoplasma infectious disease become possible.

・We have established the method of quantitatively measuring the change of the antibody value by the mycoplasmal infection that has used the lipid antigen already. Development and the condition of the sensitive diagnostic procedure of the mycoplasma infectious disease have been clarified.

・In addition, the technology of the treatment method such as the vaccines that uses this lipid antigen has been developed. The finding of the application from the pure research into the physiology revitalization like the immunological responsiveness etc. of the mycoplasma lipid antigen to the vaccine, the antibody drug, and the immunotherapy has been accumulated.

・The method of making the vaccine of the pathogenic microbe by using the synthesized antigen is an unparalleled, new technology in the world.

・Moreover, this technology can be applied to other microorganisms and the drug developments by the generality having extremely.・M Bio Technology Inc. have succeeded to determine the structures of the specific-lipid antigens of them and also succeeded to synthesize them completely by chemical synthesis. Base on these high-technology, we are developing diagnostic tools and aiming novel type of drugs. 　

・Mycoplasmas, the smallest free-living organisms known, are prokaryotes that are bounded only by a plasma membrane.

・We found Mycoplasma pneumoniae and Mycoplasma fermentans have species-specific lipid-antigens.And determined the structures. Lipid-antigens of M. pneumoniae and M. fermentans, and named GGLs (GGL Glc-type or GGL Gal-type) and GGPLs (GGPL-I or GGPL-III), respectively.

・The structure of the lipid-antigens have been well characterized, is an advantage for the further study of molecular mechanisms, for devising strategies for regulation of the immune system and for drug discovery.

・The mycoplasma vaccine is simplest component vaccine, whose component are chemically-synthesized lipid-antigen, cholesterol and phosphocholine.

・This type of vaccine is the first one in human and there is no maycoplasma vaccine available for human at present.

・In 1970s, there was clinical trials using lived vaccine or inactivated vaccine made from cultured mycoplasma, however, they failed.

・Mycoplasma mimetic particles could induce specific IgG antibodies, and had inhibition activities.

・Mycoplasma ferementans was inocurated to rabbit. Anti-M. fermentans lipid antigen IgG were elevated in rabbits. The arthritis induced by M. fermentans inoculation were significantly decreased with the pre-treatment by lipid-antigen. The arthritis is prevented by the pre-immunization with lipid-antigen.

・The process to made up the new vaccine is as follows: (First step) chemical synthesis of the lipid antigen at GLP level, (Second step) liposome process at GMP level.

・The mycoplasma vaccine induce specific antibodies in animal (mouse, rabbit etc.). The sera from immunized mouse inhibited the growth of mycoplasma (de novo study).

・Three times of subcutaneous injection, 2 weeks and 1 month intervals, IgM then IgG antibodies against the lipid-antigen are induced.

・Challenge test, pneumonia induction by mycoplasma inhalation, is under investigation at non-GLP laboratory level.

・We are planning a prophylactic vaccine against respiratory mycoplasma pneumoniae infection. Three times of subcutaneous injection, 2 weeks and 1 month intervals.  The marker is the increase of antibody titer which can be measured our novel ELISA. It was said that 100 person become mycoplasma pneumoniae pneumona in 10,000 healthy man per year.

・We are preparing for a 5-year funding application. We are considering to conduct phase I/II trial (50 subjects in 4 groups) for the efficacy and safety.

・If we can confirm the efficacy and safety with the above mentioned trial, we can do the licensing partnering with big pharmaceutical companies for the phase II study with 5000 subjects.

・Lipid-antigens are important in immune reaction. It could be used for development of vaccine prevention and therapy.

･Microorganism lipid antigen analysis (tubercle bacilli, pneumococcus, influenza bacillus, and animal mycoplasma, etc.)

・To achieve diagnosis-treatment of the mycoplasma infectious disease, a lot of fields such as a synthesis of the mycoplasma lipid antigen, a liposome formulation of the mycoplasma lipid antigen, construction of the diagnostic system, a system of the clinical examination, a clinical system, the drug development support, the drug developments, and clinical practices are related.

・Therefore, the construction of alliance with the tie-up enterprise becomes an important management strategy while promoting making of the antibody diagnosis medicine of mycoplasma of the diagnostic product a business as soon as possible.

・We want to advance the alliance construction such as the enterprise in not only the country but also Europe, the United States, and Australia, the clinical diagnosis medicine sales companies, and the clinical trial companies.