BEIJING, December 7, 2021 - Eucure Biopharma, a wholly owned subsidiary of Biocytogen, announced the completion of first patient dosing for 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 alone or in combination with anti-PD-1 mAb. Subjects are patients with advanced solid tumor 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 tumor 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 happy to see the completion of first patient dosing for phase I clinical trial of YH004 in Australia. We will continue making rapid progress in clinical studies of YH004 so that patients around the world may be able to access the innovative, safe and effective 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 tumor 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 showed YH004 alone or in combination with anti-PD-1 antibody having 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 R&D pipelines. Relying on a strong clinical development team and rich 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 of tumor and non-tumor. 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 that two products have obtained the phase II clinical approvals from both FDA and NMPA, two products have entered the phase I clinical trials in China, and four at 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. The company is committed to becoming a global headstream of new drugs and bringing the benefits to patients around the world. Based on the fully human antibody RenMabTM and RenLiteTM mice for fully human antibodies production with robust humoral responses, highly diverse antibody repertoire and superior affinity, Biocytogen has integrated its platforms in monoclonal and bi-specific antibody development platforms, in vivo drug efficacy screening platforms and strong clinical development ability to streamline the entire drug development process. Biocytogen is developing antibody drugs in large-scale for more than 1000 druggable targets known as Project Integrum. With the implementation of the Project, Biocytogen will collaborate with global partners to constantly produce many first-in-class and/or best-in-class antibody drugs to benefit patients. Headquartered in Beijing, Biocytogen has branches in Haimen Jiangsu, Shanghai and Boston US.