Over 2.8m new cases of Basal Cell Carcinoma (BCC) are diagnosed each year in the US alone with approximately 10 million new patients globally each year. BCC is estimated to result in >3,000 deaths annually.
Advanced BCC (aBCC) is a subset of BCC that is difficult to treat by surgery and existing therapeutic approaches. Worldwide, aBCC affects up to 100,000 individuals a year causing disfiguring, potentially life-threatening lesions. The therapeutics currently approved for treatment of aBCC, (vismodegib, sonidegib, and 5-FU), are limited in utility by low responder rates or side effect & compliance issues. Therefore, more cost effective, safe and efficacious therapeutic options are required for aBCC.
Biosceptre has extensive experience in the use of its topical antibody BIL010t to treat basal cell carcinomas and other skin cancers gained in informed consent patient cohorts in Australia. These studies in patients were followed up by a phase I study undertaken in the US. This study was designed to confirm safety but the data also shows the potential for efficacy, with 85% showing same size lesion or less.
Following the successful Phase I results, with excellent safety outcomes and an indications of efficacy, Biosceptre has developed the business case for BIL010t to go to market via FDA orphan indication approval and/or early access against the indication locally advanced BCC (laBCC), and is seeking licensing partners to take the program to market.