Drug intelligence / Profile preview

SPESN38

Development stage
Unknown
Lead developer
Sunstate Biosciences
Modality
Small Molecules, Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

SPESN38 is a novel formulation of SN38 (7-ethyl-10-hydroxycamptothecin), the active metabolite of irinotecan, developed using Sunstate Biosciences' proprietary single protein encapsulation (SPE) platform. This technology encapsulates the potent but poorly water-soluble antineoplastic agent SN38 within a single protein, specifically human serum albumin (HSA), without the use of artificial nanoparticles or chemical modifications. By improving solubility and delivery, SPESN38 aims to overcome the low enzymatic conversion rates associated with irinotecan and reduce systemic toxicity. Preclinical studies have demonstrated significant antitumor efficacy across various models, including Ewing sarcoma, rhabdomyosarcoma, soft tissue sarcoma, colorectal cancer, and non-small cell lung cancer. The FDA has cleared an Investigational New Drug (IND) application for SPESN38-8 for clinical development.

Other names
Single protein encapsulated SN38HSA-encapsulated SN38
02

Targets

TOP1 (DNA Topoisomerase I)

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