Drug intelligence / Profile preview

SP-002 + vismodegib

Development stage
Phase 2
Lead developer
Stamford Pharmaceuticals
Modality
Gene Therapies, Small Molecules
Administration
Intratumoral, Oral
01

Overview

SP-002 + vismodegib is an investigational combination therapy comprising SP-002, a replication-deficient adenoviral vector engineered to express human interferon gamma (IFN-γ), and vismodegib, a small molecule Hedgehog pathway inhibitor. SP-002 is administered via intratumoral injection and is designed to stimulate local anti-tumor immune responses, while vismodegib is delivered orally to inhibit aberrant Hedgehog signaling in tumor cells. The combination is under investigation primarily for the treatment of basal cell carcinoma (BCC), both in high burden (multi-lesional) and locally advanced settings. Early-phase clinical trials demonstrate safety consistent with the individual agents and suggest efficacy in achieving histological clearance of BCC lesions. SP-002 is exclusively licensed for development by Stamford Pharmaceuticals from Transgene.

Other names
vismodegibSP002SP-002SP 002Erivedge
02

Targets

SMO (Smoothened)IFNGR1 (Interferon gamma receptor 1)

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