On April 6, 2022 Biocytogen subsidiary Eucure Biopharma reported 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 (Press release, Eucure, APR 6, 2022, View Source [SID1234611543]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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."

About YH003

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.

About YH001

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.