The Taiwan biopharma’s announcement comes on the heels of the U.S. Food and Drug Administration’s clearance of an investigational new drug (IND) application for the therapy, allowing the start of the Phase 1 trial.
OBI-888 is a monoclonal antibody that targets Globo H, a glycosphingolipid molecule found on multiple tumor types. Glycosphingolipids are lipid molecules that make up the cell membrane. Compared to other lipids, they are covered by sugar molecules that play key roles in cell adhesion and cell-cell interactions, and may also play a role in cancer.
The Phase 1 study will be the first to evaluate the safety and preliminary activity of passive immunotherapy based on a monoclonal antibody targeting Globo H.
The trial will recruit patients with locally advanced or metastatic solid tumors of all types.
“We embark on a new opportunity, based on the innovation OBI has developed from its unique glycolipid cancer immunotherapy pipeline,” Amy Huang, general manager of OBI Pharma said in a press release. “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.”
The surfaces of cancer cells frequently express different types of carbohydrate antigens, like Globo H. Because healthy cells don’t express these antigens (or if they do, it’s at a much lesser count), they can be used as potential targets for stimulating an active immune response against tumor cells.
Globo H was first isolated as a glycolipid in 1983. It is highly elevated in various types of cancer and therefore is a potential target for the development of new immunotherapies with a broad spectrum.
OBI-888 is a first-in-class monoclonal antibody that selectively targets Globo H. It has been shown to induce tumor elimination via antibody dependent cell-mediated cytotoxicity (ADCC), which means it binds to the cancer cells and recruits immune cells to kill the threat. The monoclonal antibody also works to halt immunosuppressive cells and to prevent cancers from growing blood vessels.
In preclinical studies, OBI-888 has been shown to lead to tumor shrinkage at various doses. The monoclonal antibody was also found to be well-tolerated, with no adverse effects of concern in all doses tested.