On February 3, 2021 Eucure Biopharma, a biopharmaceutical company dedicated to developing immuno-oncology antibody drugs, reported that its investigational anti-CD40 antibody drug (YH003), when combined with Junshi Biosciences’ anti-PD-1 antibody Toripalimab (TUOYI), demonstrated encouraging anti-tumor activity in an ongoing Phase I/II clinical trial in Australia (Press release, Eucure, FEB 3, 2021, View Source [SID1234574586]). The trial is a multicenter, open label study, with an initial multiple-dose-escalation phase designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of YH003 in combination with Toripalimab in subjects with advanced solid tumors. The second phase is a cohort extension phase to assess the safety and preliminary efficacy of YH003/Toripalimab with or without chemotherapy in PD-1 refractory, advanced unresectable/metastatic melanoma and pancreatic ductal adenocarcinoma.

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A 68-year-old female subject with ocular melanoma and liver metastases who failed prior immunotherapy, including first-line Nivolumab (an anti-PD-1 antibody) and second-line Nivolumab/Ipilimumab (an anti-CTLA-4 antibody) combination therapy, was enrolled in the 0.1 mg/kg cohort. The subject received a single three-week cycle of YH003 monotherapy, followed by three cycles of YH003/Toripalimab combination therapy over a total of 12 weeks. Imaging assessments indicated a partial response at week 10 post-treatment, with a 38.5% reduction in the total diameter of all target lesions. No dose-limiting toxicity (DLT) was observed in the study, and the drug was well tolerated in the first two cohorts and in the ongoing third cohort.

In response, Dr. Yuelei Shen, Chairman of Biocytogen and CEO of Eucure Biopharma, commented, "We are pleased to see a patient experiencing partial remission in this first YH003 trial, which is going fast and smoothly in Australia. This result further assured us that our anti-CD40 compound YH003 has great potential to be developed into an oncology therapy in this post PD-1 era. We will take advantage of expedited regulatory programs to hopefully put this product on the market as soon as possible. Then, we will explore the full potential of this compound in a broad spectrum of indications."

About YH003

YH003 is a humanized agonistic antibody that promotes CD40 activation on antigen-presenting cells, and thus stimulates the effector activity of anti-tumor T cells. Whether used alone or in combination with anti-PD-1 antibodies, YH003 demonstrated potent anti-tumor effects in Biocytogen’s CD40 humanized mice, and significantly increased the proportion of anti-tumor T cells. YH003 demonstrated an excellent safety profile at very high doses, both in mice and primates.

About Toripalimab (TUOYI)

Toripalimab is the first anti-PD-1 monoclonal antibody to obtain a marketing approval in China. So far, more than thirty company-sponsored clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. On December 17, 2018, Toripalimab obtained a conditional approval from the NMPA for the second-line treatment of patients with unresectable or metastatic melanoma. Supplemental NDAs of Toripalimab for the third-line treatment of recurrent/metastatic nasopharyngeal carcinoma and second-line treatment of metastatic urothelial carcinoma were accepted by the NMPA in April and May 2020, respectively. Both supplemental NDAs received priority review designations from the NMPA in July 2020. In December 2020, Toripalimab was included in the National Reimbursement Drug List (NRDL) for the treatment of melanoma by the China National Healthcare Security Administration (NHSA).

In the United States, the FDA has granted Toripalimab breakthrough therapy designation for the treatment of recurrent/metastatic nasopharyngeal carcinoma, Fast Track designation for mucosal melanoma, and orphan drug designation for the treatment of nasopharyngeal carcinoma, mucosal melanoma and soft tissue sarcoma.