Self-built GMP mRNA production and synthesis system.
It is learned that the mRNA drug platform Small Microorganisms has completed nearly A million yuan of Series A financing, including Zhangjiang Torch Venture Capital, Zhuhai Longmen No., Jiuyou Wisdom, Yitai Jiuyou and Fanghua Investment, Angel Wheel Investment Fanglong Investment Investment. It is reported that this round of financing will be used for the construction of microbial mRNA drug GMP production center, carry out clinical trials in three hospitals and IND declaration of personalized tumor vaccine projects, and simultaneously promote the preliminary research of follow-up pipelines.
Spiral microbes have established two platforms for nano-delivery and mRNA synthesis, which are currently used for the development of mRNA vaccines, involving mRNA individualized cancer vaccines, mRNA infectious disease vaccines, protein defects Disease mRNA drugs, as well as genetic diseases mRNA drugs.
It is reported that the first product line of microbes, SM-Neo-Vac-1, is a new antigen-individualized mRNA vaccine for patients with advanced digestive system tumors. It can predict the patient’s new antigen by whole exon sequencing and transcriptome sequencing, make a tumor vaccine according to the specific conditions of each patient, and deliver it to the patient through subcutaneous injection for subsequent immune process. . Sp. Microorganisms will issue IND declarations for gastrointestinal tumors, lung cancer, and melanoma-related products by 2020.
At present, S. Microorganisms has established cooperative relationships with Shanghai Changhai Hospital, Shanghai Oriental Hospital, Zhengda First Affiliated Hospital, Ruijin Hospital and other domestic top three hospitals, and has carried out some scientific research. Among them, the clinical research in Shanghai Changhai Hospital, Shanghai Oriental Hospital, Zhengda First Affiliated Hospital has been incorporated into the group through ethical review. Up to now, patients receiving treatment have initially shown good safety and immune response.
Spirit Microbi CEO Li Hangwen revealed that in addition to the mRNA tumor vaccine, the company will also deploy infectious diseases such as influenza, MERS virus, tumor immunotherapy, antibodies, rare diseases and gene therapy. The field is even prevention. It is worth mentioning that Small microorganisms began in 2019 self-built GMP mRNA production and synthesis system to ensure self-synthesis IVT mRNA andproductionhigh-end nanoformulation. Li Hangwen revealed that the next in addition to pushingIn addition to the construction of the production line, it is necessary to improve the efficiency of the product process system.
About the mRNA vaccine, it is an in vitro synthesized mRNA fragment encoding a nascent antigen. The basic mechanism of action is that after nano-material packaging, it is delivered to human cells, and the subsequent translation process is completed in the human body. The patient-specific new antigen is expressed to stimulate the body’s own immune response, allowing the immune system to recognize and kill. Dead tumor cells carrying new antigens. The new antigen is a kind of abnormal protein that can be recognized by the immune system. Due to the abnormal protein produced by cancer cell mutation, it is one of the focuses of tumor immunity.
At present, in addition to the mRNA pathway, the therapeutic vaccine against new antigens has a polypeptide pathway, which directly synthesizes a polypeptide of a new antigen in vitro to cause an immune response. It is reported that has a potential advantage in terms of effectiveness, safety, coverage and cost compared to peptides; in addition, is prepared In terms of peptide preparation, the peptide vaccine has the problems of high difficulty in synthesis, water solubility, high preparation cost and long cycle. However, the mRNA vaccine does not have the above problems, and the mRNA tumor vaccine does not need HLA typing, and the antigen expressed in vivo is not. Direct immunogenicity.
Based on this, the industry generally believes that the mRNA drug platform is expected to become a disruptive iterative product. At present, the head of therapeutic vaccines worldwide has made mRNA vaccines an important research and development direction, such as Moderna, CureVac, BioNTech.
About the team, Professor Tang Dingguo, founder of the microbes, is a tenured professor of the original MD Anderson Cancer Center, director of the Department of Pharmacology and Clinical Therapy at Roseville Cancer Center, American AFS Fellow (Fellow/Academician of the American Association for the Advancement of Science); co-founder and CEO Dr. Li Hangwen received his Ph.D. from the Anderson Cancer Center at the University of Texas at the University of Texas. He has 16 years of research experience in RNA therapy, cancer therapy and immunotherapy. He is now an assistant professor at the Roseville Cancer Center and the Oriental Hospital affiliated to Shanghai Tongji University. Shen Haifa is an associate professor at the Houston Methodist Hospital of Cornell University and a famous cancer nanomedicine expert.