PCI Biotech's fourth quarter and preliminary 2019 results

Oslo (Norway), 26 February 2020 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announces its interim fourth quarter and preliminary 2019 results. Please find enclosed the report and presentation.


2019 in review - focus on execution of the pivotal RELEASE study
The overall survival data for Phase I patients receiving the pivotal fimaChem study dose are encouraging. Although it is a small sample size the results suggest a clear improvement over the best comparable published data in the high unmet need orphan indication, bile duct cancer. During the year the results were presented at key conferences in Asia-Pacific and US. Final confirmation of the safety milestone of up to two fimaChem treatments was reached in the Phase I extension study in Q2 2019 and focus since then has been on start-up activities for the pivotal RELEASE study with registration intent. The first RELEASE study patient was enrolled in Europe in Q2 2019, but a delay in the opening of study sites was experienced during 2H 2019. The first US study site opened in Q4 2019, which pushed enrolment of the first US patient into 2020. Opening of sites is not yet back on track, and study recruitment and projections are currently behind the original plan. The company has therefore activated several additional initiatives to recoup long-term patient recruitment projections, with the aim to reach interim analysis by Q2 2022.

The translation of the fimaVacc vaccination technology into humans was successfully completed in Q2 2019 and the results were presented at ESMO Immuno-Oncology in Q4 2019. The results of the Phase I study provide proof-of-concept by demonstrating improved immunogenicity of vaccines in healthy volunteers. The patent focused work initiated in 2013-2014 has started to generate results, providing additional IP protection for the development program. The development focus is two pronged; utilising the Phase I results in partnering efforts and planning for clinical proof-of-concept in a disease setting.

The collaborative fimaNAc programme continues its positive development, and the collaboration with AstraZeneca was extended and expanded during the year. The company received promising response on a patent application for mRNA delivery and a granted patent can provide valuable IP for fimaNAc.

On the corporate side, the Scientific Advisory Committee has been further strengthened to ensure adequate scientific support for continued progress of the fimaVacc programme.