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At the beginning of April 2021, Lepu Bio announced the completion of 261 million yuan in Series C financing, with a pre-investment valuation of 10 billion yuan
.
At the end of April, Lepu Bio's Hong Kong stock IPO prospectus was public, and the research and development pipeline was fully disclosed, including PD-1 putlizumab (HX008), 5 ADC drugs (targeting EGFR, HER2, CD20, TF and Claudin 18.
Putrizumab (HX008): Differentially designed PD-1 antibody
Putrizumab (HX008): Differentially designed PD-1 antibodyPutrizumab (HX008) is a differentially designed PD-1 antibody.
The S254T/V308P/N434A mutation is introduced into the Fc of IgG4 to extend the half-life
.
In the first-phase clinical trial, the half-life of a single administration is 17-24 days, and the half-life after stabilization is 18-38 days
Based on the unique molecular design, preclinical model test mouse monoclonal antibody was found Pute Li (HX008) O drug exhibits superior antitumor activity K drugs
.
The clinical progress of Putrizumab (HX008): Bio-better has obvious advantages
The clinical progress of Putrizumab (HX008): Bio-better has obvious advantagesAt the ASCO meeting in 2021, Lepu Biotech reported on the progress of two clinical studies of Putrizumab (HX008)
.
The first study is the second-line and above treatment of advanced melanoma
The overall response rate ORR of Putrizumab (HX008) for second-line and above treatment of advanced melanoma was 18.
49%, the disease control rate DCR was 44.
54%, the median progression-free survival mPFS was 3.
25 months, and the median overall survival mOS 17.
91 months
.
The second clinical trial is the second-line clinical trial of Putrizumab (HX008) for the treatment of MSI-H/dMMR advanced solid tumors
.
The overall response rate ORR of Putrizumab (HX008) in the treatment of dMMR solid tumors is 47.
67%, the disease control rate DCR is 75.
58%, the median progression-free survival mPFS has not yet reached, and the 12-month progression-free survival rate is 52.
70%
.
Although there is a lack of head-to-head comparison, the efficacy data of Pratrizumab (HX008) is better than the historical data of O drugs and K drugs
.
Furthermore, the total response rate of Pratizumab (HX008) is close to the data of Opdivo+Yervoy combination therapy
Attached table: data on the treatment of MSI-H solid tumors with Putrizumab (HX008) and other PD-(L)1 antibodies
to sum up
to sum upLepu Biotech has achieved rapid development since its establishment 3 years ago, and has established a rich R&D pipeline, including a variety of monoclonal antibodies, double antibodies, ADCs, oncolytic viruses and other new macromolecular drugs
.
Putrizumab (HX008) has a unique and differentiated design, and its preclinical research shows its advantages.
