Biocytogen/Eucure Biopharma’s YH001 (Anti-CTLA-4 Monoclonal Antibody) Approved for Phase II Multi-Regional Clinical Trial by China National Medical Products Administration
BEIJING, November 9, 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 YH001 for phase II Multi-Regional Clinical Trials (MRCT) in China.
This phase II, open-label, multi-center study (No. YH001004) will evaluate the safety and efficacy of YH001 in combination with Toripalimab (anti-PD-1 monoclonal antibody) for the treatment of patients with advanced non-small cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC). The MRCT will be conducted in the United States, Australia and China. The trial has been previously approved by the US Food and Drug Administration (FDA) and Australia regulatory authorities.
A Phase I dose-escalation study of YH001 in combination with Toripalimab in Australia (No. YH001002) evaluated the safety, tolerability, pharmacokinetics and preliminary efficacy of YH001 in patients with advanced solid tumors. 24 subjects with advanced solid tumors were enrolled, and the combination of YH001 with Toripalimab was well tolerated. Most adverse events (AE) were grade 1 (22) and 2 (19), and Grade 3 or above AE were rare (2). No dose-limiting toxicity (DLT) event was observed. Combination therapy of YH001 with Toripalimab demonstrated encouraging antitumor activity in subjects with advanced solid tumors. There were 3 partial responses (PR) and 7 instances of stable disease (SD). YH001/Toripalimab combination therapy also showed a very benign safety profile.
Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma, said that the approval of the phase II MRCT of YH001 by China NMPA is a milestone for Biocytogen and Eucure Biopharma. Following the approval of a phase II MRCT for YH003 by the US FDA and China NMPA, YH001 is also approved for the phase II MRCT by the US FDA and China NMPA. This is an endorsement for YH001 and YH003 as well as Biocytogen’s antibody discovery platforms and Eucure Biopharma’s clinical development abilities. We will continue making rapid progress in the clinical development of YH001 in China and around the world to bring benefits to patients with new treatment options as soon as possible.
YH001 is an anti-CTLA-4 monoclonal antibody which enhances immune responses to tumor cells through the removal of regulatory T cells (Treg) from the tumor microenvironment. Blocking the inhibitory signals of anti-tumor responses to enhance the anti-tumor responses is considered to be the most promising tumor immunotherapy. CTLA-4 and PD-1 are considered two important immune checkpoints. They control the activation of anti-tumor immune responses by regulating different types of T cells and they are considered to be the fundamental targets for tumor immunotherapy.
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.