PCI Biotech: “A transformative year”
Our portfolio company PCI Biotech published their full year report for 2017 today.
Per Walday, CEO of PCI Biotech, comments: “The achievements in 2017 has transformed PCI Biotech to a pivotal phase ready company with two promising assets in clinical development. The regulatory discussions last year provided important information on the requirements to bring fimaCHEM to the market and our focus is now on progression of all activities leading to start of the pivotal development phase. The clinical translation of the fimaVACC asset has provided promising initial results, suggesting that fimaVACC can provide highly sought-after features for vaccination technologies, such as early responses and high response rates.”
Highlights
- New funds raised enabling further progress in development programmes. Successful rights issue completed in January 2017, enabling PCI Biotech to progress the fimaCHEM programme in bile duct cancer towards pivotal phase.
- Received important guidance from regulators for development of fimaCHEM in bile duct cancer.Encouraging outcome from regulatory meetings on the development for treatment of bile duct cancer.
- Granted Orphan Drug Designation (ODD) for fimaporfin in bile duct cancer by the US FDA. ODD is a significant regulatory milestone providing important development and commercialisation benefits.
- Promising initial clinical results for the fimaVACC programme. The initial clinical results on overall T-cell responses indicate enhanced cellular immune responses, with early and high response rates.
- Progress in research collaborations with key players for the fimaNAc programme. Collaboration projects with key players within nucleic acid therapeutics were expanded and extended.
- Executive management team further strengthened with Dr Olivecrona as Chief Medical Officer. Dr Olivecrona leads the execution of all clinical development programmes.
