DEP^® irinotecan is a novel, patented dendrimer nanoparticle formulation of SN38, the active metabolite of the widely used anti-cancer drug irinotecan (marketed as Camptosar^®), delivered using Starpharma’s proprietary DEP^® technology.

Camptosar® and all generic forms of conventional irinotecan carry ‘black box’ warnings mandated by the US Food and Drug Administration (FDA) for both neutropenia and severe diarrhoea, which can be dose-limiting and life-threatening. The severe diarrhoea caused by conventional irinotecan results from the production of toxic metabolites during the liver metabolism of irinotecan to SN38.

DEP^® irinotecan was designed to directly deliver SN38 and eliminate the need for liver metabolism, thereby avoiding the production of toxic metabolites. Unlike conventional irinotecan, DEP^® irinotecan does not require metabolic conversion in the liver, which can lead to variable clinical efficacy and toxicity among patients, including gastrointestinal complications such as nausea, vomiting, and severe diarrhoea. By eliminating the need for metabolic conversion, DEP^® irinotecan allows for direct dosing of SN38 and avoids these gastrointestinal adverse effects. In Starpharma's Phase 2 study of DEP^® irinotecan, reports of severe or life-threatening (≥ grade 3) diarrhoea were notably absent across more than 100 patients enrolled in the study.

In both preclinical and clinical studies, DEP^® irinotecan has demonstrated promising anti-tumour efficacy in patients with heavily pre-treated colorectal cancer and platinum-resistant ovarian cancer, as well as a favourable safety and tolerability profile.

Target indications:

• Advanced colorectal cancer
• Platinum-resistant/refractory ovarian cancer

Patent filings: DEP^® irinotecan has patent filings to 2039 (plus up to an additional ~5 years).

DEP^® irinotecan is a clinical-stage product/candidate. It has not received a marketing or regulatory authorisation in any jurisdiction.