Fimavacc is under clinical development by PCI Biotech Holding and currently in Phase I for Head And Neck Cancer. According to GlobalData, Phase I drugs for Head And Neck Cancer have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Fimavacc’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Fimavacc overview

Fimavacc is under development for the treatment of melanoma and head and neck cancer. The therapeutic candidate is an HPV peptide vaccine in combination with amphinex. The vaccine candidate targets antigen-specific CD8 T cells. It is administered intradermally along with a toll-like receptor 3 ligand, hiltonol as adjuvant (poly ICLC) that causes the activation of dendritic cells. It is also administered through intradermal route. The vaccine candidate is developed based on photochemical internalisation (PCI) technology which involves CTL induction based on the use of amphinex (photo-sensitizer). The PCI technology re-localizes endocytosed antigens from endosomes to the cytosol in APCs and thereby makes the antigens accessible for the MHC Class I presentation. The vaccine targets telomere.

PCI Biotech Holding overview

PCI Biotech Holding (PCI Biotech) is a biopharmaceutical company that focuses on the development and commercialization of novel therapies for the treatment of cancer. The company develops therapeutic products based on its proprietary photochemical internalization technology. Its lead product candidate includes photosensitizer fimaporfin and fimaChem program consists a clinical Phase I and II clinical study in bile duct cancer, an orphan indication. The companY applies three distinct anticancer paradigms such as fimaChem, an enhancement of chemotherapeutics for localized treatment of cancer, fimaVacc, a t-cell induction technology for therapeutic vaccination and fimaNAc, nucleic acid therapeutics. PCI Biotech is headquartered in Oslo, Norway.

For a complete picture of Fimavacc’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.