Biocytogen Subsidiary, Eucure Biopharma, Announces the First Patient Dosing for a Phase I Multi-regional Clinical Trial of YH002 (Anti-OX40 mAb) in Combination with YH001 (Anti-CTLA-4 mAb) in Australia
BEIJING, CHINA, March 8, 2022 – Eucure Biopharma, a wholly owned subsidiary of Biocytogen, announced the first patient dosing for a phase I multi-regional clinical trial (MRCT) of YH002 (anti-OX40 monoclonal antibody, mAb) in combination with YH001 (anti-CTLA-4 mAb) (No. YH002004) in Australia. This phase I MRCT will be conducted in Australia and China.
The clinical trial is an open-label, dose-escalation phase I study designed to evaluate the safety, tolerability and preliminary efficacy of YH002 in combination with YH001 in patients with advanced solid tumors. Pharmacokinetics and immunogenicity of YH001 and YH002 will also be evaluated.
Eucure Biopharma has previously completed mono-dose-escalation studies for YH001 and YH002. The results show that both YH001 and YH002 have good tolerance and safety.
Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma, said, “Both YH001 and YH002 are developed from Biocytogen’s evidence-based in vivo efficacy screening platform. Using animal models, we found for the first time, that combination of YH002 and YH001 has very good antitumor activity. We expect the results from animal models can be verified in patients. We are hopeful that these platforms will continue to drive the discovery and development of novel therapeutic antibodies, ADCs and bispecific ADCs for future clinical benefit.”
YH002 is a recombinant anti-OX40 humanized IgG1 antibody. Targeting OX40 enhances anti-tumor responses both by activating effector T cells and inhibiting or exhausting regulatory T cells (Treg). In preclinical studies, YH002 demonstrated excellent specificity, affinity and safety. In vivo studies using Biocytogen’s humanized mouse models demonstrated improved therapeutic potential of YH002 compared to benchmark antibodies, and indicated promising potential for combination therapy.
YH001 is an anti-CTLA-4 monoclonal antibody that aims to enhance the anti-tumor immune response through removal of Treg from the tumor microenvironment. Combination therapies that block multiple inhibitory immune checkpoints (including CTLA-4 and PD-1) are currently considered to be promising treatments for multiple types of tumors, due to their potential to influence the activity of multiple populations of T cells.
About Eucure Biopharma
As a wholly owned subsidiary of Biocytogen, Eucure Biopharma is responsible for clinical development of Biocytogen’s R&D pipelines, focusing on antibody drug therapy for oncology and other indications. Eucure’s strong clinical development team has established an innovative product pipeline for more than 10 targets. Currently, two products have launched phase II MRCTs, and two are in phase I clinical trials.
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. is a global biotechnology 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 Project Integrum (also called RenMiceTM HiTS Platform). With the implementation of Project Integrum, Biocytogen has initiated collaborations with dozens of partners worldwide, and will continue such collaborations to produce a variety of 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, USA.