First quarter 2019 results

Posted on May 8, 2019

Oslo (Norway), 8 May 2019 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company today announces its first quarter 2019 result. Please find enclosed the report and presentation.

First sites for the pivotal fimaCHEM “RELEASE” study open for enrolment and successful translation of fimaVACC into man.

Final confirmation of safety with two treatments was reached in April 2019 in the fimaCHEM Phase I extension study, without the report of any adverse reactions that would limit the delivery of up to two treatments in the RELEASE study. The pivotal RELEASE study will therefore be initiated with up to two treatments and it will also include a seamless safety review when eight patients have been given two treatments. The overall survival data for Phase I patients receiving the pivotal dose are encouraging, suggesting a clear improvement over the best comparable published data. All necessary approvals have been achieved in six countries and the first RELEASE study sites are open for enrolment of patients. PCI Biotech’s focus is now to bring fimaCHEM to the market for the treatment of inoperable bile duct cancer through successful completion of the RELEASE study.

The translation of the vaccination technology, fimaVacc, into humans has been successfully completed. The results of the Phase I study provide proof of concept by demonstrating improvement of immunogenicity of vaccines in healthy volunteers. The overall clinical data covering more than 90 subjects provide clinical support of fimaVACC’s potential to enhance the cellular immune responses that are especially important for therapeutic effect of vaccines. The results are now to be utilised to establish fimaVacc in the immunotherapy field.

On the corporate side, the Scientific Advisory Committee has been further strengthened with Professor Sjoerd van der Burg to ensure adequate scientific support for continued progress of the fimaVACC programme in 2019.

After reviewing the overall results of the Phase I fimaVACC study, Prof. van der Burg commented: “These encouraging results obtained by including fimaporfin during vaccination merit further exploration in a relevant clinical disease to assess if the enhanced immune responses translates into clinical benefit.”

Per Walday, CEO of PCI Biotech, comments: “The encouraging results of the Phase I study is a major milestone for our fimaVACC programme. The results provide proof of concept and efficacy in terms of dosing in humans as well as an overall characterisation of tolerability, in keeping with the target objectives of the trial and paving the way for further development in a clinical setting. We were also pleased to receive the confirmation on reached safety endpoint in the fimaCHEM extension study from the Cohort Review Committee. The RELEASE study is now being initiated and two sites are open for enrolment. All approvals have been achieved in six countries and several further sites will open for enrolment in the coming weeks. The company is now fully focused on successful completion of this transforming study.”

Highlights

fimaCHEM

  • First sites for the pivotal RELEASE study open for enrolment
  • Successful safety read-out in the Phase I extension study confirmed (subsequent event)
  • Completion of the full Phase I study and formal closure of recruitment (subsequent event)
  • Presented Phase I dose-escalation results at the annual conference of the US Cholangiocarcinoma Foundation and at the 3rd Asia-Pacific Cholangiocarcinoma conference in Taiwan

fimaVACC

  • Successful clinical translation (subsequent event)

Corporate

  • Further strengthened the Scientific Advisory Committee

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A presentation in English will be held today, Wednesday 8 May 2019, at Oslo Cancer Cluster Innovation Park.

Time: Wednesday 8 May 2019, 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 webcast (access through link https://webtv.hegnar.no/presentation.php?webcastId=97815265 ) 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 is about to initiate the RELEASE study, a pivotal clinical trial with the potential of accelerated / conditional marketing approval as a first-line treatment given the rare disease status and unmet medical need. 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 statements
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.

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

Attachments
PCI Biotech Q1 2019 Interim Report
PCI Biotech Q1 2019 Interim Presentation