Cancer Immunotherapy
Immunotherapy is a promising emerging cancer treatment, with important products already on the market and an extensive development pipeline, especially in the fields of checkpoint inhibitors and therapeutic vaccines.

immuno

Therapeutic vaccination and CTL induction
There are currently more than 250 therapeutic vaccines in development against various types of cancers. Therapeutic vaccination is a potentially effective and powerful immunotherapeutic approach with many advantages:

Powerful: attacks cancer systemically
Specific:    attacks only cancer cells expressing the tumour antigen – hence fewer side effects
Durability of action: chemotherapy has a limited action in time but vaccines continue to protect by   teaching the immune system
Indications: potentially all cancers
Safety: contrary to traditional cancer treatments – immunotherapy has the potential to be extremely safe

PCI – An innovative CTL induction technology based on the use of a proprietary photosensitizer
Effective induction of CTLs (Cytotoxic T Lymphocytes) is key to realize the huge potential of therapeutic cancer vaccination, but this has been difficult to achieve with today’s vaccination technologies. PCI Biotech’s CTL induction technology may provide a solution to this problem, thereby substantially improving the potential to trigger the immune system to fight both cancers and infectious diseases.

Mechanism of action:

  • Induction of CTLs is essential for the generation of an immunological response that can attack the tumour cells. Induction of CTLs is typically mediated through MHC Class I antigen presentation by antigen presenting cells (APCs).
  • The PCI technology can re-localise endocytosed antigens from endosomes to the cytosol in APCs, thereby making the antigens accessible for the MHC Class I presentation machinery.

Status:
The fimaVACC program aims to enhance the cellular immune responses important for therapeutic effect of vaccines. This proprietary vaccination technology has entered clinical Phase I.

Clinical study
PCI Biotech will expedite clinical validation of the fimaVACC technology through a Phase I/Proof of Principle study in healthy volunteers that commenced Q3 2016. This is a Dose escalation, Sequential-group Study with the aim to validate safety and provide clinical translation of the preclinical results. Two antigens have been chosen to improve chances of detecting induction of B- and T-cell immune responses (HPV peptides and KLH), and Hiltonol is used as adjuvant (poly-ICLC).

The primary objectives are to determine Safety, Tolerability and Immune Response when Antigen/Adjuvant is given alone and in combination with PCI (fimaporfin and light).

The study may also provide important knowhow with regards to the optimal treatment regimen with fimaVACC.