Presentation

Company Profile
PCI Biotech is a Norwegian biopharmaceutical company in late-stage clinical development, focusing on cancer therapies through its photochemical internalisation (PCI) technology platform and its 3 active programmes: fimaCHEM (enhancement of chemotherapeutics for localised treatment of cancer), fimaVACC (enhanced T-cell induction for therapeutic vaccination), and fimaNAc (nucleic acid therapeutics delivery). The lead fimaCHEM programme consists the pivotal RELEASE study with registration intent of Amphinex® in bile duct cancer, an orphan indication a high unmet medical need and no approved therapy. Clinical proof-of-concept has been achieved in the fimaVacc programme, which applies a unique mode of action to enhance the essential cytotoxic effect of therapeutic cancer vaccines.

Recent highlights
In November 2020, PCI Biotech announced that the successful Phase I vaccination proof of concept study was published in the high impact journal Frontiers in Immunology. In Q1 2021, screening and enrolment increased in the RELEASE study, and the first US patient was enrolled. In May 2021, the company entered into a research collaboration with the South Korean company OliX Pharmaceuticals, a developer of RNAi therapeutics.

Outlook
The company’s focus is on the enrolment of patients into the RELEASE study. Data from an interim readout for potential accelerated approval are expected by 2H 2023. At the same time, the company plans to drive further development of firmaVACC and progress its multiple collaborations.