BEIJING, April 7, 2022 - Biocytogen subsidiary Eucure Biopharma announced the first patient dosing for a phase I clinical trial (No. YH003005) of YH003 (anti-CD40 monoclonal antibody, mAb) in combination with YH001 (anti-CTLA-4 mAb) and pembrolizumab (anti-PD-1 mAb) in Australia.
The study is an open-label, dose-escalation study designed to evaluate the safety, tolerability and efficacy of YH003 in combination with YH001 and pembrolizumab in patients with advanced solid tumors. Pharmacokinetics and immunogenicity of YH003 will also be evaluated.
“Previous phase I clinical trials of YH003/Toripalimab (anti-PD-1 mAb) combination therapy and YH001/Toripalimab combination therapy indicate desirable safety profiles and preliminary efficacy for both products,” said Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma. “The combination of CTLA-4, PD-1 and CD40 mAbs is based on their different but complementary biological mechanisms; we hope that the three-drug combination study can further strengthen the antitumor efficacy to benefit patients.”
YH003 is a humanized IgG2 agonistic CD40 antibody. Whether used as a single agent or in combination with anti-PD-1 mAb drugs, YH003 demonstrated strong anti-tumor effects against multiple tumor models in Biocytogen’s humanized CD40 mice, without exhibiting hepatotoxicity or other toxicities. Pharmacodynamic studies in mice indicate that YH003 significantly increased the infiltration of anti-tumor T cells into tumors.
YH001 is an anti-CTLA-4 monoclonal antibody. CTLA-4 is a key target for tumor immunotherapies, due to the potential to enhance the immune response to tumor cells and promote removal of regulatory T cells (Treg) from the tumor microenvironment. Blocking the inhibitory signals from both CTLA-4 and PD-1 to enhance the anti-tumor responses is considered a promising tumor immunotherapy, as they control the different types of T cells.
About Eucure Biopharma
As a wholly owned subsidiary of Biocytogen, Eucure Biopharma undertakes the mission of clinical development for Biocytogen’s R&D pipelines. Relying on a strong clinical development team and extensive clinical development experience, Eucure Biopharma focuses on antibody drug therapy for oncology and other indications. The company has established a product pipeline for more than 10 targets, with two products in launched phase II MRCT and two in phase I.
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. is a global biotech company that streamlines the research and development of antibody drugs using innovative technologies, including RenMabTM and RenLiteTM mice for fully human antibody production, high-throughput antibody screening platforms, in vivo drug efficacy screening capabilities and strong clinical development ability. Biocytogen is undertaking a large-scale project to develop antibody drugs in collaboration with global partners for more than 1000 druggable targets, known as Project Integrum. With the implementation of Project Integrum, Biocytogen has entered ongoing collaborations with dozens of partners worldwide and has established a pipeline of 12 core products, with 2 products in phase II MRCT and 2 products in phase I trials. Headquartered in Beijing, Biocytogen has branches in Haimen Jiangsu, Shanghai, Boston, USA and Heidelberg, Germany.