Eucure Biopharma, a wholly owned subsidiary of Biocytogen, announced the first patient dosing for a phase I clinical trial of YH004 (anti-4-1BB monoclonal antibody, mAb) (No. YH004002) in Australia.
The study is an open-label, multi-center, classical dose-escalation phase I study of YH004 monotherapy or YH004 in combination with anti-PD-1 mAb. Subjects are patients with advanced solid tumors or relapsed/refractory non-Hodgkin’s lymphoma (R/R NHL). The objective of the study is to evaluate the safety, tolerability and efficacy of YH004 alone or in combination with anti-PD-1 mAb in patients with advanced solid tumors or R/R NHL. Pharmacokinetics and immunogenicity of YH004 will also be evaluated.
Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma, said that Eucure Biopharma plans to continue making rapid progress in clinical studies of YH004, so that patients around the world may be able to access the therapy as soon as possible.
YH004 is a humanized IgG1 agonistic monoclonal antibody (mAb) targeting 4-1BB with high affinity and specificity. YH004 can enhance the immune response against tumors through multiple mechanisms. Antibody-mediated activation of 4-1BB can enhance the co-activation of T cells, enhance NK cell cytotoxicity, promote the maturation of antigen presenting cells (APCs) and inhibit regulatory T cells (Tregs). Both in vitro and in vivo data indicates that YH004, whether alone or in combination with anti-PD-1 antibody, exhibits significant anti-tumor activities with good safety and tolerability.
About Eucure Biopharma
Eucure Biopharma undertakes the mission of clinical development for Biocytogen’s R&D pipelines. Relying on a strong clinical development team with extensive experience, Eucure Biopharma develops innovative drugs for oncology and other indications to meet clinical needs for patients around the world. The company has established a pipeline for more than 10 targets. Currently, four products have received clinical trial approvals in the US and China, including two products that have obtained phase II clinical approvals from both the FDA and NMPA, two products that have entered phase I clinical trials in China, and four in phase I clinical trials in Australia.
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. is a global biotech company that drives the research and development of new drugs with innovative technologies. Using RenMabTM and RenLiteTM mice for fully human antibody production, Biocytogen has integrated its monoclonal and bispecific antibody development platforms, in vivo drug efficacy screening platforms and strong clinical development ability to streamline the entire drug development process. Biocytogen is undertaking a large-scale project to develop antibody drugs in collaboration with global partners for more than 1000 druggable targets, known as the RenMiceTM HiTS Platform. Headquartered in Beijing, Biocytogen has branches in Haimen Jiangsu, Shanghai, and Boston, USA.