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Publication of research and development results of industrialized new PD-1 nanoantibody drug expressed by Pichia pastoris
2019-10-16
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In October 2019, the latest research result of Shanghai Luoqi Biotechnology Co., Ltd., "Blocking the PD-1-PD-L1 axis by a novel PD-1specific Nanobody expressed in year as a potential thermal forever", was published in the journal of Biological and Biophysical Research Communications under ELSEVIER.


Monoclonal antibody drugs targeting PD-1/PD-L1 are currently revolutionary therapeutic means for a variety of malignant tumors. FDA has approved several monoclonal antibodies that block PD-1 or PD-L1. The overall response rate of malignant tumors is about 10% - 45%, showing encouraging results. However, the traditional monoclonal antibody is produced in mammalian cells, its preparation process is complex, its production cost is high, and its social and economic burden is heavy, which limits the availability of drugs to a certain extent; On the other hand, due to the large molecular weight of monoclonal antibody, its tissue penetration ability is weak, and its inhibition on tumor is weakened to a certain extent. Therefore, the development of next generation antibody drugs with low cost and stronger anti-tumor activity still has important socio-economic and clinical value.


As an ideal tool for the development of new biological drugs, nano-antibodies may have better advantages in clinical therapeutic effects than ordinary antibodies or other therapeutic molecules due to their high tissue permeability, high stability and high solubility. In addition, nanoantibodies can be prepared at a low cost and in a large scale in many systems such as Pichia Pasteuri, Saccharomyces cerevisiae and Escherichia coli.


Shanghai Luoqi Biotechnology Co., Ltd. developed a new functional anti-PD-1 nanoantibody Nb97 expressed in Pichia pastoris system. The nano antibody can effectively block the interaction between PD-1 and PD-L1, and has good tumor inhibition effect in vivo. In order to improve the half-life and inhibitory activity of Nb97 serum, Rocky successfully used the yeast expression system to produce the Nb97-human serum albumin (HSA) fusion protein by large-scale fermentation, with the expression yield of 2.3 g/L. Therefore, the PD-1 nanoantibody expressed in yeast has the potential to become a new generation of product with lower production cost and shorter production cycle than the existing monoclonal antibody targeting PD-1. We hope that the new anti-PD-1 nanoantibody will enter clinical development as soon as possible, be approved for marketing as soon as possible, reduce the cost of medication for patients, and improve the accessibility of drugs.