Orphan drug designation entitles Viventia to various incentives, including seven years of exclusive marketing rights if Proxinium receives marketing approval by the FDA. Historically, many orphan drugs have received expedited regulatory review because they have been developed to treat serious or life-threatening illnesses, leading to more rapid approval times.
Proxinium is a targeted therapeutic consisting of a proprietary antibody fragment conjugated with a cancer-killing payload. It targets a cell surface protein found on most head and neck cancers and has been designed to deliver a therapeutically potent anticancer payload directly to tumors, avoiding healthy, normal tissue.
Viventia Biotech is advancing a new generation of monoclonal antibody therapeutics designed to offer safer, more beneficial therapies for cancer patients. Lead drug candidate Proxinium is in clinical development for the treatment of head and neck cancer and bladder cancer, and several of the company’s other product candidates are in preclinical development.