15P - Clinical validation of photochemical internalisation (fimaVacc) – A novel technology for enhancing cellular immune responses to peptide- and protei...

Date 05 November 2016
Event ESMO Symposium on Immuno-Oncology 2016
Session Lunch and general poster viewing
Presenter Anders Høgset
Citation Annals of Oncology (2016) 27 (suppl_8): viii4-viii17. 10.1093/annonc/mdw527
Authors A. Høgset1, T. Otterhaug2, L. Wabakken2, K. Eivindvik2, L. Finnesand2, K. Nord2, P. Walday2
  • 1Research, PCI Biotech AS, 0379 Oslo - Oslo/NO
  • 2Research, PCI Biotech AS, Oslo/NO

Abstract

Aim/Background

To investigate the safety and immune response of fimaVacc-based peptide- and protein antigen vaccination in healthy volunteers.

Methods

FimaVacc is a technology that in pre-clinical studies has been shown to increase MHC class I antigen presentation, leading to strongly enhanced cytotoxic- and helper T-cell responses to various types of vaccines. FimaVacc involves formulating the vaccine with a photosensitising compound (fimaporfin) and a toll-like receptor (TLR) agonist, administering the vaccine intradermally, and illuminating the vaccination site the day after vaccine injection. A phase I clinical study in healthy volunteers has been given approval by the authorities in the United Kingdom. In the study, the subjects will be administered two vaccines containing HPV16 E7 peptide antigens or Keyhole Limpet Hemocyanin as models for peptide- and protein-based vaccines. Both antigens will be formulated with the TLR3 agonist poly-ICLC (Hiltonol), and up to three vaccinations will be performed. In addition to assessment of local and systemic adverse effects, cellular and humoral immune responses will be analysed by ELISPOT and ELISA assays, respectively.

Results

The principle of the fimaVacc technology will be presented, together with preclinical results showing that fimaVacc strongly enhances both cellular and humoral immune responses and improves anti-tumour effects in different clinically relevant mouse models. The design of the clinical study will also be presented. The clinical study is expected to commence in September 2016, so no clinical results are yet available.

Conclusions

The fimaVacc technology strongly enhances the effect of therapeutic cancer vaccines in pre-clinical models. A phase I study in healthy volunteers will start in the very near future.

Clinical trial identification

EudraCT number 2016-001023-30

Legal entity responsible for the study

PCI Biotech AS

Funding

PCI Biotech AS

Disclosure

A. Høgset, T. Otterhaug, L. Wabakken, K. Eivindvik, L. Finnesand, K. Nord, P. Walday: Employed by, and owns stocks in, PCI Biotech AS.