Oslo (Norway), 20 March 2018 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company today announces its full year result. Please find enclosed the full year 2017 presentation.
2017 was a year of significant progress for PCI Biotech. The year started with the completion of a strongly supported rights issue that together with a grant from the Norwegian Research Council provided the Company with funds to complete key programme milestones. The positive early signs of tumour response in the Phase I study with fimaCHEM in bile duct cancer, presented at the International Liver Congress in the spring, have during the year translated into encouraging survival data, with 25% of the patients in Phase I still being alive. An extension study has been initiated to explore whether it is possible to introduce repeated fimaCHEM treatment in the pivotal study, which could potentially enhance efficacy further. The Company was also granted Orphan Drug Designation (ODD) by FDA for fimaporfin in bile duct cancer. Further interactions with regulatory authorities in Europe and the US during the year provided important clarifications on the development path for fimaCHEM in this disease, enabling the Company to initiate preparations for a pivotal study.
The fimaVACC Phase I study provided promising initial signs of enhanced cellular immune responses at tolerable dose levels and the study continues with the objective to determine the optimal dosing regimen. Research collaborations based on fimaNAc progressed further during the year with expansion and extension of two ongoing collaboration programmes.
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.”
- 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.
A presentation in English will be held today, Tuesday 20 March 2018, at Oslo Cancer Cluster Innovation Park.
Time: Tuesday 20 March 2018, 08.30am – 09.30am CET (local time).
Venue: Jónas Einarsson aud. (2nd floor, entrance 2B), Oslo Cancer Cluster Innovation Park,
Ullernchausséen 64, Oslo.
The presentation can be followed as a live audiocast (access through the link http://webtv.hegnar.no/presentation.php?webcastId=83472058 or the company’s website under “Investors – Reports and presentations – Webcasts”). It will be possible to post questions through the webcast console.
About PCI Biotech
PCI Biotech is a biopharmaceutical company focusing on development and commercialisation of novel therapies for the treatment of cancer through its innovative photochemical internalisation (PCI) technology platform. PCI is applied to three distinct anticancer paradigms: fimaCHEM (enhancement of chemotherapeutics for localised treatment of cancer), fimaVACC (T-cell induction technology for therapeutic vaccination), and fimaNAc (nucleic acid therapeutics delivery).
Photochemical internalisation induces triggered endosomal release that is used to unlock the true potential of a wide array of therapeutic modalities. The company’s lead fimaCHEM programme consists of a Phase I/II clinical study in bile duct cancer, an orphan indication with a high unmet need and without approved products. fimaVACC applies a unique mode of action to enhance the essential cytotoxic effect of therapeutic cancer vaccines, which works in synergy with several other state-of-the-art vaccination technologies. fimaNAc utilises the endosomal release to provide intracellular delivery of nucleic acids, such as mRNA and siRNA therapeutics, thereby addressing one of the major bottlenecks facing this emerging and promising field.
For more information visit: www.pcibiotech.com
PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo
Ronny Skuggedal, CFO, firstname.lastname@example.org, Mobile: +47 9400 5757
This announcement may contain forward-looking statements, which as such are not historical facts, but are based upon various assumptions, many of which are based, in turn, upon further assumptions. These assumptions are inherently subject to significant known and unknown risks, uncertainties and other important factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this announcement by such forward-looking statements. PCI Biotech disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.