On November 21, Taiwan’s OBI Pharma announced that the FDA has granted OBI-888 the right to treat orphan drugs for pancreatic cancer. OBI-888 is a first-in-class passive immunotherapy treatment of monoclonal antibody against Globo H, a tumor cell surface antigen, whose mechanism of action is antibody-dependent cytotoxicity, antibody-dependent macrophage phagocytosis, and Complement-dependent cytotoxic effects. OBI-888 also has anti-immunosuppressive and anti-angiogenic effects.
Source: Taiwan Hao Ding official website
On January 17, OBI-888 received the FDA’s Phase I clinical license and is currently conducting Phase I trials at the University of Texas MD Anderson Cancer Center, enrolling patients with solid tumors that have been locally transferred, including pancreatic cancer, breast cancer, and gastric cancer. , esophageal cancer, colorectal cancer and lung cancer.
Pancreatic cancer originates from exocrine or endocrine pancreatic cells and is a fatal disease. Because of the limited treatment options for pancreatic cancer, only early detection and surgical resection can be performed. Even so, the 5-year survival rate of these patients may be only 34.3%. Because pancreatic cancer is asymptomatic in the early stage, most patients are diagnosed or misdiagnosed at the end of the disease. It is usually too late to seek surgical treatment. The 5-year survival rate is only 8.5%.
Huang Xiumei, general manager of Taiwan’s Haoding, said: “OBI-888’s FDA-approved pancreatic cancer orphan drug qualification is a milestone in the development of new Globo H monoclonal antibody. Currently, the treatment options for pancreatic cancer are very limited, and Taiwan’s Haoding focuses on development for unmet needs. Therapies for medical needs will do their utmost to help people fight cancer, as well as quality of life.”
This is also the third orphan drug qualification obtained by Taiwan Hao Ding from the FDA. In July and September of this year, the DNA alkylating agent OBI-3424 (TH-3424) was awarded the orphan drug qualification for the treatment of hepatocellular carcinoma and acute lymphocytic leukemia by the FDA. OBI-3424 is a pro-chemotherapy new drug that selectively releases potent DNA alkylating agents under the action of AKR1C3 enzyme (especially for tumors with high expression of AKR1C3). It is a Taiwanese taiding from the United States in June 2017. Threshold Pharmaceuticals acquired a one-time payment.
Established in 2002, Taiwan Hao Ding focuses on the development of innovative cancer therapies. At present, the fastest development in the product pipeline is the active immunotherapy Anagloxad simolenin (OBI-822) for the treatment of breast cancer, which is currently in the phase III.