Lepu Biopharma Highlights Differentiated PD-1 Antibody Pucotenlimab (HX008) with Emerging Clinical Advantages in IPO Prospectus

Jun 07, 2021 10:29 CST Updated 10:29

In early April 2021, Lepu Biopharma announced the completion of its C-round financing, raising RMB 261 million and achieving a pre-money valuation of RMB 10 billion. At the end of April, Lepu Biopharma publicly released its Hong Kong IPO prospectus, fully disclosing its R&D pipeline, which includes the PD-1 inhibitor putalimab (HX008), five ADC drugs (targeting EGFR, HER2, CD20, TF, and Claudin 18.2, respectively), the PD-L1 monoclonal antibody LP002, a CD47 monoclonal antibody, a TIGIT monoclonal antibody, a PD-L1/TGF-β bispecific antibody, and the oncolytic virus CG0070.

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Putelizumab (HX008): A Differentially Designed PD-1 Antibody

Putelimab (HX008) is a differentially designed PD-1 antibody that incorporates S254T/V308P/N434A mutations into the Fc region of IgG4 to extend its half-life. In Phase I clinical trials, the half-life was 17–24 days after a single dose and 18–38 days at steady state.

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Based on its unique molecular design, preclinical studies in mouse models have demonstrated that putrilimab (HX008) exhibits superior anti-tumor activity compared to Opdivo and Keytruda.

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Clinical Progress of Putelimab (HX008): Bio-better Advantages Already Evident

At the 2021 ASCO Annual Meeting, Lepu Biopharma reported progress on two clinical studies of putrilimab (HX008). The first study evaluated its use as a second-line or later treatment for advanced melanoma.

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For putrelimab (HX008) as second-line or later treatment for advanced melanoma, the overall response rate (ORR) 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) was 17.91 months.

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The second clinical trial is a Phase II study of putrilimab (HX008) for the second-line and later treatment of advanced solid tumors with MSI-H/dMMR.

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The overall response rate (ORR) of putrilimab (HX008) in the treatment of dMMR solid tumors was 47.67%, the disease control rate (DCR) was 75.58%, the median progression-free survival (mPFS) had not been reached, and the 12-month progression-free survival rate was 52.70%.

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Although head-to-head comparisons are lacking, the efficacy data for putrilimab (HX008) appear superior to historical data for Opdivo and Keytruda. Furthermore, the overall response rate of putrilimab (HX008) approaches that of the combination therapy with Opdivo and Yervoy. These data suggest that the differentiated design and preclinical advantages of putrilimab (HX008) may translate into clinical superiority.

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Summary

Since its establishment three years ago, Lepu Biopharma has achieved rapid development and built a robust R&D pipeline, including multiple novel large-molecule drugs such as monoclonal antibodies, bispecific antibodies, antibody-drug conjugates (ADCs), and oncolytic viruses. Putlerlimab (HX008) features a unique differentiated design and has demonstrated advantages in preclinical studies. Phase II clinical data in MSI-H/dMMR solid tumors indicate its potential to become a “bio-better” therapeutic. We look forward to putlerlimab (HX008) successfully passing subsequent clinical trials and reaching the market soon to benefit patients.