OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today 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 flagship active immuno-oncology therapy, Adagloxad Simolenin (OBI-822), OBI Pharma’s Chief Science Officer and Acting Chief Medical Officer, Dr. Tony Yu, noted, “This clinical trial intends to verify the safety and preliminary activity profile of OBI-888, a monoclonal antibody that targets Globo H selectively.”
Amy Huang, General Manager of OBI Pharma, added, “We embark on a new opportunity, based on the innovation OBI has developed from its unique glycolipid cancer immunotherapy pipeline. With this trial, OBI is taking a first-step towards testing the safety and initial efficacy of a new class of monoclonal antibodies. We are excited to bring forth new and effective tools in the fight against cancer.”
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.