Beijing, China, December 8, 2021 – Eucure Biopharma, a wholly owned subsidiary of Biocytogen, announced the first patient dosing for a phase II clinical trial of YH003 (anti-CD40 monoclonal antibody, mAb) (No. YH003004) in Australia.
The open-label, multi-regional clinical trial (MRCT) will evaluate the efficacy and safety of YH003 in combination with Toripalimab (anti-PD-1 mAb) for the treatment of patients with PD-(L)1 resistant unresectable/metastatic melanoma or pancreatic ductal adenocarcinoma (PDAC). The trial will be conducted in Australia, the United States, China and other countries or regions. Each subject will receive 0.3 mg/kg YH003 and 240 mg Toripalimab every-three-week to evaluate the antitumor efficiacy and safety in three parallel cohorts. The first two cohorts will consist of subjects with unresectable/metastatic melanoma that failed PD-1/PD-L1 treatment, or subjects with unresectable/metastatic PDAC who failed first-line treatment, respectively. The third cohort will evaluate YH003/Toripalimab plus standard chemotherapy (Nab palitaxel + Gemcitabine) as first-line treatment in subjects with unresectable/metastatic PDAC. The study adopts Simon’s two-stage optimization design. The evaluation will be made when each cohort has recruited 18 subjects.
The study marks the first phase II clinical trial for Biocytogen. Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma, said that the company will continue making rapid progress to develop safe and effective innovative medicines to benefit patients worldwide.
YH003 is a humanized IgG2 agonistic CD40 antibody. 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, without exhibiting hepatotoxicity or other toxicities. Pharmacodynamic studies in mice indicates that YH003 significantly increased the infiltration of anti-tumor T cells into tumors. Phase I dose-escalation data indicates a desirable safety profile of YH003/Toripalimab.
About Eucure Biopharma
Eucure Biopharma develops innovative antibody drugs for Biocytogen’s R&D pipelines in oncology and other indications. Relying on a strong team with extensive clinical development experience, the company‘s pipeline includes more than 10 targets. At present, four products have received clinical trial approvals in the US and China including two products that have obtained phase II clinical approvals from both the FDA and NMPA, two products that have entered phase I clinical trials in China, and four in 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. 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 the RenMiceTM HiTS Platform. Headquartered in Beijing, Biocytogen has branches in Haimen Jiangsu, Shanghai, and Boston, USA.