Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation of Antigen/Adjuvant

Phase 1 Completed 96 enrolled PCI Biotech AS

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Fimaporfin (TPCS2a) is a photosensitiser drug being developed by PCI Biotech AS for use in novel Photochemical Internalisation (PCI) technology. PCI technology is designed to enhance the effects of other drugs in a site-specific, light-directed manner and is used to re-localise endocytosed molecules from endosomes to cytosol. This research study is evaluating the use of the PCI Technology in combination with adjuvant and vaccine antigens for safety and induction of immune responses.

Timeline

Start: 2016-09
Primary completion: 2018-03-26
Completion: 2018-03-26

Publications

Otterhaug T, Janetzki S, Welters MJP, Hakerud M, Nedberg AG, Edwards VT, Boekestijn S, Loof NM, Selbo PK, Olivecrona H, van der Burg SH, Hogset A. Photochemical Internalization Enhanced Vaccination Is Safe, and Gives Promising Cellular Immune Responses to an HPV Peptide-Based Vaccine in a Phase I Clinical Study in Healthy Volunteers. Front Immunol. 2021 Jan 8;11:576756. doi: 10.3389/fimmu.2020.576756. eCollection 2020.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fimaporfin	Other / unclassified	—	Intramuscular
Subject	HPV E7	Peptide	—	Intravenous
Subject	keyhole limpet hemocyanin	Vaccine	—	Intramuscular
Background	Hiltonol	Other / unclassified	—	Intrathecal

Indications

No indication recorded.