Viventia Biotech Inc. announced that its lead drug candidate Proxinium has been granted orphan drug designation from the US FDA for the treatment of advanced, recurrent head and neck cancer.

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. Proxinium targets a cell surface protein found on most head and neck cancers and has been designed to deliver a therapeutically potent anti-cancer payload directly to tumours, avoiding healthy, normal tissue.

Head and neck cancer, comprising cancers of the larynx, tongue, mouth, oral cavity, and pharynx, is the sixth most common form of cancer globally.

The US Orphan Drug Act provides financial, regulatory and marketing incentives to companies to help facilitate the development and marketing of drugs for the treatment of rare diseases or conditions that affect fewer than 200,000 patients in the United States.