Title:
ANTI-PD-1 ANTIBODY AND STABILIZED PREPARATION THEREOF
Document Type and Number:
WIPO Patent Application WO/2022/012428
Kind Code:
A1
Abstract:
The present invention relates to an antibody binding to human PD-1 or a fragment thereof, and a composition containing the anti-human PD-1 antibody or the fragment thereof, the composition preferably being an injection preparation. The anti-human PD-1 antibody performs screening by using a hybridoma technology to obtain an antibody molecule 317 having high affinity binding to both a human PD-1 extracellular region domain recombinant protein and a cell surface human PD-1 and capable of specifically blocking binding of receptors and ligands of PD-1/PD-L1 and PD-1/PD-L2, and a humanized antibody h317 having unchanged affinity and specificity is further obtained by means of a humanization technology is further obtained. According to structural analysis of an antigen-antibody compound crystal, mutants of h317 light and heavy chain CDR regions are constructed, so that a 317-series derivative antibody is obtained. On the basis of the anti-human PD-1 antibody h317, an antibody stabilized preparation provided by means of three rounds of component selection and concentration optimization improves the storage stability and temperature adaptability of the antibody, and prolongs the storage life of the antibody preparation especially an injection.
Inventors:
ZHANG YANZHEN (CN)
REN JIE (CN)
MEI FEI (CN)
TANG PEIPEI (CN)
CHEN KUN (CN)
TAN XIAODING (CN)
REN JIE (CN)
MEI FEI (CN)
TANG PEIPEI (CN)
CHEN KUN (CN)
TAN XIAODING (CN)
Application Number:
PCT/CN2021/105458
Publication Date:
January 20, 2022
Filing Date:
July 09, 2021
Export Citation:
Assignee:
MABWELL SHANGHAI BIOSCIENCE CO LTD (CN)
JIANGSU MABWELL HEALTH PHARMACEUTICAL R&D CO LTD (CN)
JIANGSU MABWELL HEALTH PHARMACEUTICAL R&D CO LTD (CN)
International Classes:
A61K39/395; C07K16/28; A61P35/00; C12N15/13
Domestic Patent References:
| WO2020252418A2 | 2020-12-17 | |||
| WO2021119516A1 | 2021-06-17 | |||
| WO2021119429A1 | 2021-06-17 |
Foreign References:
| CN111423510A | 2020-07-17 | |||
| CN106390115A | 2017-02-15 |
Other References:
WANG, M. , WANG, J. , WANG, R. , JIAO, S. , WANG, S. , ZHANG, J. , ZHANG, M: "Crystal structure of Fab of a PD-1 monoclonal antibody MW11-h317 in complex with PD-1", PROTEIN DATA BANK, 30 October 2019 (2019-10-30), pages 1 - 22, XP055887469, DOI: 10.2210/pdb6JJP/pdb
WANG MINGZHU, WANG JUNCHAO, WANG RONGJUAN, JIAO SHASHA, WANG SHUANG, ZHANG JINCHAO, ZHANG MIN: "Identification of a monoclonal antibody that targets PD-1 in a manner requiring PD-1 Asn58 glycosylation", COMMUNICATIONS BIOLOGY, vol. 2, no. 1, 1 December 2019 (2019-12-01), pages 1 - 10, XP055887476, DOI: 10.1038/s42003-019-0642-9
WANG MINGZHU, WANG JUNCHAO, WANG RONGJUAN, JIAO SHASHA, WANG SHUANG, ZHANG JINCHAO, ZHANG MIN: "Identification of a monoclonal antibody that targets PD-1 in a manner requiring PD-1 Asn58 glycosylation", COMMUNICATIONS BIOLOGY, vol. 2, no. 1, 1 December 2019 (2019-12-01), pages 1 - 10, XP055887476, DOI: 10.1038/s42003-019-0642-9
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