Oslo (Norway), 13 February 2019 - PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company today announces its interim fourth quarter and preliminary 2018 result. Please find enclosed the report and presentation.
Solid performance through 2018, moving towards initiation of the pivotal “RELEASE” study
The fully underwritten rights issue of NOK 360 million completed in October 2018 provides PCI Biotech with the funds needed for the pivotal fima Chem study, beyond interim read-out of results for potential accelerated/conditional marketing approval. The pivotal study, which for further communication purposes will be called “RELEASE”, is expected to start in the first half of 2019.
The dose-escalation part of the Phase I study has provided positive early signs of efficacy, with a median overall survival of 21.7 months for the dose selected for the pivotal study. Although the data sample is small, the results with a single fima Chem treatment indicate a clear improvement over the best comparable published data.
Preliminary confirmation of safety with two treatments was reached in Q4 in the 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. PCI Biotech’s focus is now to bring fima Chem to the market for the treatment of inoperable bile duct cancer through successful completion of the RELEASE study.
The translation of the vaccination technology, fima Vacc , into humans by demonstrating improvement of immunogenicity of vaccines in a Phase 1 study in healthy volunteers is a main priority for PCI Biotech to establish the company in the immunotherapy field. The dose-finding part of the Phase I study identified a well-tolerated dosing regimen and the interim data suggest enhancement of several parameters of importance for vaccination. PCI Biotech is collaborating with international experts to finalise and publish the in-depth analysis and characterisation of the immune responses from Phase I.
The fima NAc programme continued positive development, with two new research collaborations established and the research collaboration with an undisclosed top-10 pharma company was extended twice during 2018.
On the corporate side, the clinical organisation and the Scientific Advisory Committee have both been reinforced to ensure continued progress in our key areas in 2019.
Per Walday, CEO of PCI Biotech, comments: ”The efficacy results achieved in bile duct cancer are encouraging and the preliminary confirmation that it is safe to repeat the treatment further strengthens the positive prospects of the fima Chem development programme. The company is now all set to initiate the RELEASE trial and fully focused on successful completion of this transforming study. The positive interim data on T-cell responses with fima Vacc are further supported by initial data suggesting a CD8 T-cell response component. The response hurdle was set high by the selection of a vaccine antigen that it is notoriously difficult to induce CD8 T-cell responses with in man and it is encouraging to see that a majority of the subjects in the two analysed fima Vacc groups are responders. Immunotherapy is a complex and rapidly progressing field and the immunological expertise in the Scientific Advisory committee has been further reinforced with cutting edge competence by the addition of Professor van der Burg.”
Highlights
* Completed fully underwritten rights issue of NOK 360 million
* Preparations for the pivotal RELEASE study progressing towards initiation in the first half of 2019
* Continued positive early signs of efficacy from fima Chem Phase I dose-escalation
* Preliminary confirmation of safety read-out from the Phase I extension study
* Presented Phase I dose-escalation fima Chem results at the 2018 ESMO congress and at the annual conference of the US CCA Foundation in Jan 2019 (subsequent event)
* Phase I interim fima Vacc data suggest enhancement of several parameters of importance for vaccination
* US patent granted for “band-aid-like“ device for fima Vacc skin illumination / injection
* Extension of preclinical fima NAc research collaboration agreement with a top-10 large pharma company
* Further strengthened the clinical organisation and the Scientific Advisory Committee
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A presentation in English will be held today, Wednesday 13 February 2019, at Oslo Cancer Cluster Innovation Park.
Time: Wednesday 13 February 2019, 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 webcast (access through link http://webtv.hegnar.no/presentation.php?webcastId=97603030 ) 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: fima Chem (enhancement of chemotherapeutics for localised treatment of cancer), fima Vacc (T-cell induction technology for therapeutic vaccination), and fima NAc (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 fima Chem 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. fima Vacc 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. fima NAc 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 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.
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