Oslo, 29 August 2017 – Please find enclosed the financial report and presentation for second quarter and first half year 2017.
PCI Biotech reported important progress for the fimaCHEM programme during 1H 2017, with early promising signs of effect in Phase I. The study has also provided encouraging interim overall survival data averaging 15.6 months per end July 2017 (median 14.4 months), with 25% of the patients still being alive. These promising results may be further strengthened by repeating the treatment. Safety for repeated treatment will be investigated in a Phase I extension study and the first patient in this study was treated in August. Regulatory interactions to clarify the fastest way to market and subsequent preparations for Phase II will run in parallel with the extension study, thereby minimising time to initiation of a potential pivotal Phase II study with repeated treatment.
Clinical translation of the fimaVACC asset is progressing with tolerability being established and the initial results on overall T-cell responses from the study are expected to be available during 2H 2017.
The fimaNAc programme has showed positive progress and the research collaborations with RXi Pharmaceuticals and a top-10 pharma company have both entered into new stages during 2017.
The rights issue completed in Q1 2017 enables PCI Biotech to progress the fimaChem programme through regulatory interactions to determine the fastest way to market, as well as the Phase I extension study and other preparations for initiation of Phase II. The proceeds, together with a grant from the Norwegian Research Council, will also cover the clinical translation of the promising fimaVACC asset. The organisation will be strengthened with Dr Olivecrona as Chief Medical Officer (CMO) from October 2017.
Per Walday, CEO of PCI Biotech, comments: “After the rapid initiation of the fimaCHEM Phase I extension study, we now have full focus on effective completion of this study and the regulatory interactions to clarify fastest route to market. We are also eagerly awaiting the initial results on overall T-cell responses from the fimaVACC Phase I study and will revert to the market as soon as these are available.”
- Encouraging interim overall survival data from Phase I
- First patient treated in the Phase I extension study
- Tolerability of the vaccination technology established – awaiting initial results on overall T-cell responses
- RXi Pharmaceuticals collaboration expanded into the field of immuno-oncology
- Top-10 pharma collaboration extended and entered into in vivo studies
- Dr Hans Olivecrona appointed as Chief Medical Officer
- Completed the fully underwritten rights issue of NOK 70 million
- Awarded up to NOK 14.3 million in public grants for further development of the vaccination platform
A presentation in English will be held today, Tuesday 29 August 2017, at Oslo Cancer Cluster Innovation Park.
Time: Tuesday August 29 2017, 09.00am -10.00am CEST (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, see link (http://webtv.hegnar.no/presentation.php?webcastId=58639798). 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 statements, whether as a result of new information, future events or otherwise.