Henlius (02696.HK) announced on June 28th that a Phase 1 clinical trial of HLX15, a biosimilar of daratumumab developed by the company, has been successfully completed in male healthy volunteers in China. The study results showed that HLX15 had similar pharmacokinetic characteristics and comparable safety and immunogenicity with daratumumab from different sources. The study achieved all pre-defined endpoints.
This study is a Phase 1 clinical trial conducted in male healthy volunteers in China to compare the pharmacokinetic characteristics, safety, tolerability, and immunogenicity of HLX15 and daratumumab injection (reference drug). The study is divided into two parts: Part 1 is a single-center, randomized, open-label, two-arm, parallel-controlled Phase 1a study, in which subjects are randomly assigned in a 1:1 ratio to receive HLX15 or daratumumab commercially available in China (8mg/kg, single dose, intravenous infusion); Part 2 is a multi-center, randomized, double-blind, four-arm, parallel-controlled Phase 1b study, in which subjects are randomly assigned in a 1:1:1:1 ratio to receive HLX15 or daratumumab commercially available in the United States, European Union, or China (8mg/kg, single dose, intravenous infusion). The main endpoint of this study is the area under the concentration-time curve from 0 to infinity (AUC0-inf).
Secondary endpoints include other pharmacokinetic parameters, safety, and immunogenicity. The study results showed that HLX15 had similar pharmacokinetic characteristics and comparable safety and immunogenicity with daratumumab from different sources. The study achieved all pre-defined endpoints.
HLX15 is a biosimilar of daratumumab developed by the company, intended for the treatment of multiple myeloma ("MM"). Daratumumab is a humanized IgG1κ monoclonal antibody against CD38, which can bind to CD38 expressed on the surface of tumor cells and induce tumor cell apoptosis through complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cell-mediated phagocytosis (ADCP), as well as various other immune-related mechanisms such as Fcγ receptors.
In addition, daratumumab can also reduce MM cells by reducing myelosuppressive cells and consuming CD38-expressing positive immunoregulatory T and B cells. According to the Technical Guidelines for the Research and Evaluation of Biosimilars (Trial), the company has conducted a comprehensive head-to-head pharmacological and in vitro and in vivo pharmacological comparative study of HLX15 and the original drug daratumumab injection. The study results showed that HLX15 was highly similar to daratumumab injection.