Biocytogen/Eucure Biopharma Announce the Completion of First Patient Dosing for Phase I Clinical Trial of YH004 (Anti-4-1BB Monoclonal Antibody) in Australia
BEIJING, CHINA, December 7, 2021 – 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 and classical dose-escalation phase I study of YH004 monotherapy or 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
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 develops innovative drugs to meet clinical needs for patients in China and around the world. Biocytogen focuses on antibody drug therapy for oncology and other indications. The company has established a product pipeline for more than 10 targets. At present, 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.