OBI Pharma Announces FDA Clearance Of IND Application for A Phase 1 Study Of Monoclonal Antibody Cancer Immunotherapy (OBI-888)
January 17, 2018 at 05:00 am EST
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OBI Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for a Phase 1 study of a monoclonal antibody cancer immunotherapy targeting Globo H, a glycolipid antigen (OBI-888). OBI plans to enroll patients with locally advanced or metastatic solid tumors of all types. Building off the findings of the Phase 2 trial for its active immuno-oncology therapy, Adagloxad Simolenin (OBI-822). OBI-888 is a novel first-in-class monoclonal antibody, which selectively targets Globo H, an antigen expressed in up to 15 epithelial cancers. This Globo H targeting antibody has been shown to induce tumor-killing via antibody dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cell-mediated phagocytosis (ADCP), and complement dependent cytotoxicity (CDC). OBI-888 is also anti-immunosuppressive and anti-angiogenic. In pre-clinical xenograft animal models in multiple tumor types (pancreatic, colon, lung, and breast), OBI-888 has demonstrated tumor shrinkage at various doses. In pre-clinical single and repeated dose toxicology studies, OBI-888 was well-tolerated, and no adverse effect was found in all the doses tested. OBI Pharma owns global rights to OBI-888.
OBI Pharma, Inc. is a Taiwan-based company principally engaged in the development of new pharmaceuticals. The Company mainly operates its businesses through the research and development of novel cancer and infectious disease therapies. It also develops next generation active immunotherapies to treat cancers, including lung, prostate, pancreatic, stomach and ovarian cancers. It is engaged in the development of OBI-822 (formerly OPT-822/821), an active immunotherapy new drug for metastatic breast cancer; the research and development of therapeutic vaccine OBI-833 for the treatment of new generation of cancers, as well as the development of cancer testing reagent OBI-868.