BEIJING, November 2, 2021 - Eucure Biopharma, a wholly owned subsidiary of Biocytogen dedicated to developing proprietary antibody drugs, announced that the China National Medical Products Administration (NMPA) has approved YH003 for phase II Multi-Regional Clinical Trials (MRCT) in China.
NMPA has approved Eucure Biopharma to conduct a phase II MRCT: a phase II, open-label, multi-center study (No. YH003004) will evaluate the safety and efficacy of YH003 in combination with Toripalimab (anti-PD-1 monoclonal antibody) for the treatment of patients with unresectable/metastatic melanoma and pancreatic ductal adenocarcinoma (PDAC). The MRCT will be conducted in the United States, Australia and China. The trial has been approved previously by the Australian regulatory agency in Australia and US Food and Drug Administration (FDA).
In the phase I dose-escalation study of YH003 in Australia (No. YH003003), 20 subjects were enrolled and the evaluation of dose limiting toxicity (DLT) for all dose groups has completed. YH003 is well tolerated and most of adverse events (AE) are grade 1 and 2. There are two grade 3 AEs. Among all subjects, there is 1 DLT event. No treatment-related severe adverse events (SAE) nor death related to AE occurred. Among 13 imaging evaluable subjects, there are 2 PR and 3 SD.
Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma, said that the approval of the phase II MRCT of YH003 by China NMPA following the approval by US FDA and Australia regulatory agency is a milestone for Biocytogen and Eucure Biopharma, which is an endorsement for YH003. We will continue making rapid progress in clinical development of YH003 in China and around the world to complete the clinical development of YH003 as soon as possible and bring benefits to patients with new treatment options.
YH003 is a humanized IgG2 agonistic antibody targeting CD40, a receptor that promotes the activation of antigen-presenting cells and the effector activity of anti-tumor T cells. CD40 activation is a key regulatory point in tumor immunotherapy, effectively transforming cold tumors lacking immune cell infiltration into hot tumors that respond well to tumor immunotherapy. At preclinical stage, Eucure Biopharma used humanized CD40 mice independently developed by Biocytogen to screen for antibodies that can inhibit tumor growth but without hepatotoxicity or other toxicities. Whether used as a single agent or in combination with anti-PD-1 monoclonal antibody drugs, YH003 demonstrated strong anti-tumor effects against multiple tumor models in Biocytogen’s humanized CD40 mice. Pharmacodynamic studies in mice indicates that YH003 significantly increased the infiltration of anti-tumor T cells into tumors. Available clinical data from phase I dose-escalation trial indicates a desirable safety profile of YH003 in combination with toripalimab, and YH003 might be a potential breakthrough treatment for PD-1-refractory melanoma.
About Eucure Biopharma
Eucure Biopharma, a subsidiary of Biocytogen, is a China based innovative biotechnology company with global vision, specializing in developing innovative antibody drugs with independent intellectual property rights. Relying on a strong clinical development team with extensive experiences, 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, four products have entered Phase I clinical stages in Australia. As a wholly owned subsidiary of Biocytogen, Eucure Biopharma is focused on clinical development. For more information, please visit www.eucure.com.
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 as its mission. 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 single-cell antibody discovery, gene editing, large-scale animal model supply, and screening to form a new approach to streamline the entire drug development process. Biocytogen actively promotes the independent and cooperative development of new drugs. For more, please visit http://en.biocytogen.com.cn.