Oslo, 28 November 2017 – Please find enclosed the financial report and presentation for third quarter 2017.
Granting of orphan status from the FDA was an important milestone for the fimaCHEM programme during Q3 2017, as was the inclusion of the first patient in the Phase I study extension exploring the potential for repeated treatment in Phase II. The orphan status recognises the therapeutic benefits we seek to bring to the bile duct cancer patients in need of better local treatments. Regulatory interactions to clarify the fastest way to market continued during the quarter and are expected to be completed by end 2017.
The initial results from the the fimaVACC Phase I study indicate enhanced overall T-cell responses at tolerable dose levels. The results also suggest that vaccination with the fimaVACC technology provides both early responses and high response rates, which are two highly sought-after features of vaccination platforms. Notably, the best responses are seen at the lowest dose level tested. Further expansion of the Phase I study is therefore planned to investigate even lower doses.
The alliances in the fimaNAc programme have showed positive progress and the research collaboration with a top-10 pharma company entered into a new stage (in vivo) in Q3 2017.
Per Walday, CEO of PCI Biotech, comments: “The extension of fimaCHEM Phase I is progressing according to plan. Our focus is now on finalisation of the regulatory interactions and progression of all activities leading to start of the next development phase. From the fimaVACC Phase I study we have received promising initial clinical results suggesting that vaccination with this technology is characterised by several important and highly sought-after features for vaccination platforms. We are therefore intensifying this work and further expanding the study to explore optimal conditions for vaccination.”
- Granted US Orphan Drug Designation
- Phase I extension study progressing according to plan
- Promising interim clinical results from Phase I suggesting enhancement of several parameters of importance for vaccination
- Expanding the clinical Phase I study to identify optimal dosing
- Extension of the top-10 pharma Collaboration
- Strengthened management team further by the appointment of Dr Hans Olivecrona as Chief Medical Officer
A presentation in English will be held today, Tuesday 28 November 2017, at Oslo Cancer Cluster Innovation Park.
Time: Tuesday November 28 2017, 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 link Q3 2017 Audiocast 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.
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 statem