First quarter 2018 report and presentation
Oslo (Norway), 8 May 2018 - PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company today announces its interim first quarter 2018 result. Please find enclosed the Q1 2018 report and presentation.
The dose-escalation part of the fimaCHEM Phase I study in bile duct cancer continues to deliver encouraging survival data, with the latest update from March 2018 providing an interim average overall survival of 17.4 months, with 25% of the patients still being alive. The company is currently focusing on completion of discussions with advisors and contract research organisations on the full pivotal study design, as well as completion of the extension study that may allow for repeated fimaCHEM treatment in the pivotal study.
The initial results from the fimaVACC Phase I study in healthy volunteers reported last year indicate enhanced overall T-cell responses at tolerable dose levels, as well as early responses and high response rates. The dose-finding part of the study is completed with more than 90 subjects included, offering a large library of clinical fimaVACC test samples. The near term focus is now on in-depth analysis and characterisation of the immune responses.
Our alliances in the fimaNAc programme are progressing well and the research collaboration with a top-10 pharma company, which entered into a new stage (in vivo) in Q3 2017, has been further extended to the end of Q2 2018.
The listing of PCI Biotech was on 27th April 2018 transferred from Oslo Axess to Oslo Børs. This is seen as a natural, important development step, as the Company is approaching a pivotal clinical phase, and the market cap and shareholder base have developed positively over the last years. The listing on Oslo Børs is expected to enhance the visibility, strengthen the Company profile and make the shares more attractive to investors.
Per Walday, CEO of PCI Biotech, comments: “The deliberations with clinical advisors on the final design of the fimaCHEM pivotal study in bile duct cancer is progressing well towards study initiation in second half of 2018. We will revert to the market with information on the full study design when these discussions have concluded. The dose-finding part of the fimaVACC Phase I study has been completed with more than 90 subjects included. We will now focus on in-depth characterisation of the promising immune response results and discuss these with international immunology experts, before determining the fimaVACC strategy. We are very pleased to announce the transfer of listing to Oslo Børs, which we expect will increase the visibility and attractiveness of the company.”
Highlights
Encouraging interim overall survival data from fimaCHEM Phase I in bile duct cancer. Interim average overall survival of 17.4 months, with 25% of the patients still being alive per March 2018.
Preparations for fimaCHEM pivotal phase progressing towards initiation 2H 2018. Further information on the study and the development strategy will be announced following completion of discussions with clinical Advisors.
Dose-finding part of the fimaVACC Phase I study completed and initial results suggests enhancement of several parameters of importance for vaccination. Overall T-cell responses indicate enhanced cellular immune responses, with early and high response rates. Near-term focus is on further in-depth analysis of immune response characteristics.
Progress in research collaborations for the fimaNAc programme. Collaboration project with key player within nucleic acid therapeutics extended to the end of first half 2018.
Listing at Oslo Børs. PCI Biotech listed at Oslo Børs per 27 April 2018, as a transfer from Oslo Axess (subsequent event).
A presentation in English will be held today, Tuesday 8 May 2018, at Oslo Cancer Cluster Innovation Park.
Time: Tuesday 8 May 2018, 08.30am - 09.30am 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 (access through link http://webtv.hegnar.no/presentation.php?webcastId=84032843) 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.
Contact information:
PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo
Ronny Skuggedal, CFO, rs@pcibiotech.no, Mobile: +47 9400 5757
Forward-looking statementsThis 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.