BIL010t is a topical therapy targeting basal cell carcinoma (BCC), locally advanced BCC, and other skin cancers. It is an ointment which can be self-administered and is formulated with a polyclonal antibody as the active pharmaceutical ingredient.
This programme has delivered excellent Phase I safety and tolerability data alongside a strong indication of efficacy in man.
In the USA, there are over 2.8m new cases of Basal Cell Carcinoma (BCC) diagnosed each year and BCC is estimated to result in >3,000 deaths annually. Globally, approximately 10 million new patients are diagnosed annually.
Locally advanced BCC (laBCC) is a subset of BCC that is difficult to treat by surgery and existing therapeutic approaches. Worldwide, laBCC affects up to 100,000 individuals a year causing disfiguring, potentially life-threatening lesions. The therapeutics currently approved for treatment of laBCC, (vismodegib, sonidegib, and 5-FU), are limited in utility by low responder rates, side effect and/or compliance issues. Therefore, more cost effective, safe and efficacious therapeutic options are required for laBCC.
Biosceptre completed the phase I study for BIL010t against BCC in the US. confirming safety and tolerability. Although not designed to assess efficacy, the trial showed that 85% of patients post treatment had the same or a reduced lesion area. This data was published recently.
With a promising result in the Phase I trial against BCC, including excellent safety outcomes and indications of efficacy, Biosceptre has developed a business case and initiated clinical planning for BIL010t to go to market for treatment of laBCC via FDA orphan indication approval and/or early access. Biosceptre is seeking licensing partners to take the programme to market.