On January 26, 2021 Eucure Biopharma, a subsidiary of Biocytogen, reported the first patient enrollment for a Phase I clinical trial in China to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of its anti-CTLA4 monoclonal antibody (YH001) in patients with solid tumors (Press release, Biocytogen, JAN 26, 2021, View Source [SID1234574320]).
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In May 2020, Eucure Biopharma initiated a first-in-human Phase I dose-escalation trial of YH001 in advanced solid tumors in Australia. One run-in cycle was used to explore the safety and tolerability of escalating doses of YH001 monotherapy, followed by four treatment cycles of YH001 in combination with fixed dose Toripalimab (an anti-PD-1 antibody). In the first four cohorts, no grade 3 or higher adverse events (AE) were observed, demonstrating a favorable safety profile.
The Phase I trial in China will assess the safety and preliminary efficacy of YH001 as a single agent in patients with advanced solid tumors. The leading principal investigator is Professor Cai-Cun Zhou, Director of the Department of Oncology at Shanghai Pulmonary Hospital. The trial will be conducted concurrently with Professor Yongsheng Wang at West China Hospital and Professor Tongtong An at Peking University Cancer Hospital.
Dr. Yuelei Shen, CEO of Biocytogen and Eucure Biopharma, said that the first patient enrolled for YH001 treatment in China "will be another important milestone for Eucure Biopharma". "Eucure Biopharma’s mission is to bring the latest global therapeutic concepts and new drugs to Chinese patients, with scientific innovation and patient welfare as our top priority. We hope to take this opportunity to strengthen our cooperation with domestic experts to smoothly advance the business of Biocytogen/Eucure Biopharma in China."
About YH001
YH001 is an anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) humanized monoclonal antibody that relieves CTLA-4-mediated immunosuppression and enhances the T-cell-mediated antitumor immune response. YH001 can trigger antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) to remove CTLA-4 expressing cells, especially regulatory T cells, to treat various tumors. YH001 has demonstrated excellent affinity, safety, and in vivo efficacy in Biocytogen’s humanized mouse models.