On July 6, 2021 Eucure Biopharma, a wholly owned subsidiary of Biocytogen dedicated to developing antibody drugs with independent intellectual property rights, reported that the U.S. Food and Drug Administration (FDA) has approved two phase II clinical trials for YH001 (anti-CTLA-4) and YH003 (anti-CD40) in the United States (Press release, Eucure, JUL 6, 2021, View Source [SID1234584632]).
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A phase II, non-randomized, multi-center clinical study will evaluate the use of YH001 in combination with Junshi Biosciences’ anti-PD-1 monoclonal antibody (Toripalimab) for the treatment of advanced non-small cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC). A phase II, open-label, multi-center study will evaluate the safety and efficacy of YH003 combined with Toripalimab for the treatment of PD-1-resistant unresectable/metastatic melanoma and pancreatic ductal adenocarcinoma (PDAC). Both trials are multi-regional clinical trials, and will be conducted in the United States, Australia and China. The YH003 phase II clinical trial in Australia was approved by the Australian regulatory agency in May 2021 following a phase I dose-escalation study launched in May 2020.
Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma, said that the approvals signify "a milestone" for Eucure Biopharma. "In just one year, both products advanced from Australian phase I clinical trials to the FDA approvals of phase II trials. This is not only an affirmation of the clinical safety and preliminary efficacy of these two products, but also an affirmation of Biocytogen’s drug discovery platform and in vivo drug efficacy screening model. I am very pleased to see that the Eucure team was able to advance clinical development so efficiently. We will continue to actively promote the clinical trials of YH001 and YH003 in China and around the world. With our RenMice HiTS Platform, Eucure’s clinical pipeline will continue to expand with potentially novel best-in-class and first-in-class mAbs for oncologic, viral and autoimmune diseases."
About YH001
YH001 is a humanized IgG1 monoclonal antibody targeting CTLA-4. YH001 enhances the immune response against tumor cells and promotes removal of regulatory T cells from the tumor microenvironment. In phase I first-in-human dose-escalation studies in patients with advanced solid tumors conducted in Australia and China, YH001 has shown best-in-class potential with an improved safety profile compared to Ipilimumab (Yervoy), and promising preliminary efficacy when used in combination with Toripalimab.
About YH003
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. 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 the YH003 phase I dose-escalation trial indicates a desirable safety profile when combined with Toripalimab, and a potential breakthrough treatment for PD-1-refractory melanoma.