On August 4, 2020, Beroni Group Limited (“Beroni Group”) announced that it has signed an agreement with GenScript Biotech Corporation (“Genscript”) to collaborate in the development of a medical solution utilizing nanobody technology for COVID-19, especially in conducting pseudovirus neutralization test, humanization and affinity maturation of nanobodies with the objective of increasing the antibody affinity to target the antigen by five to ten-fold.
Genscript will provide these services to Beroni: (1) Perform pseudovirus neutralization assay with candidate antibody (2) Production and characterization of humanized antibodies and (3) Using PML (Precise Mutagenesis Library) and FASEBA (Fast Screening for Expression, Biophysical-Properties and Affinity) to carry out affinity maturation and purification of the antibodies. The process is expected to take 15-18 weeks.
Nanobody-based technology will not only have the potential to rapidly deliver an effective and safe testing and treatment solution for COVID-19, but also provide an economic, scalable, high-yield and large-scale production capability. These are key benefits for addressing the current pandemic and potential global treatment issues.
In May 2020, after identifying the 24 specific nanobodies with high affinity to the new coronavirus N- protein and S-protein antigens through high-throughput screening, Beroni’s R&D team has used structural biology, computational biology and biophysical methods to further analyze and improve the properties of these nanobodies. Through rational design and transformation, the affinity and specificity of these nanobodies have been greatly increased. The ELISA (Enzyme Linked Immunosorbent Assay) was successfully used to determine the affinities of antibodies, and nanobodies with good affinity are selected for affinity enhancement and humanization. The scientific team has also successfully established a prokaryotic expression and purification system for nanobodies in vitro. In this respect, they have expressed and purified the 16 S-protein nanobodies with a purity of 98%.
Jacky Zhang, Executive Chairman of Beroni Group, said, “We are pleased to be able to work with Genscript, one of the world’s largest molecular biology CDMO (Contract Development and Manufacturing Organization) companies, to use their leading CDMO platform to further advance our study into the use of nanobodies for treating COVID-19 patients. Nanobody, which has more natural advantages than traditional antibody, is more suitable as a neutralizing antibody to treat coronavirus patients. Nanobody treatment is fast emerging as an effective antibody drug in the market. We will do our utmost best to accelerate our clinical study so that we can produce a timely, safe and effective medical solution to help stop the global spread of this highly infectious disease.”
Brian Min, CEO of GenScript ProBio, said, “COVID-19 is still on the rise globally. During this period, we are pleased to collaborate with Beroni Group to use our CDMO platform to facilitate research on nanobodies for the treatment of COVID-19 patients. It is believed that with our joint efforts, this technology can appear in the market as soon as possible for the benefit of patients.”
Genscript Biotech Corporation, a global biotech company, is a leading life sciences research and application service provider that applies its proprietary technology to various fields from basic life sciences research to translational biomedical development, industrial synthetic products, and cell therapeutic solutions. It has business operations in over 100 countries worldwide with legal entities located in the United States, China, Japan, Singapore, Netherlands and Ireland.
Genscript will provide strong technical support for the humanized modification and affinity maturation of nanobodies of the project. The next stage of the study will further advance the preclinical research study such as live virus testing, animal testing and formulation development. It is expected that the animal testing will be completed towards end of 2020 and the clinical trials to commence in early 2021. The clinical trials will take about a year to complete. The nanobodies can be used for treatment of coronaviruses, which are not only for SARS-CoV-2 but also for other coronaviruses such as SARS coronavirus of 2003 and MERS coronavirus of 2012 which are members of the same coronavirus family.
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