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PCI Biotech: Second quarter and first half 2019 results

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Oslo (Norway), 28 August 2019 - PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company today announces its second quarter and first half 2019 result. Please find enclosed the report and presentation.

First patient enrolled into the pivotal fimaChem “RELEASE” study, successful clinical proof-of-concept of fimaVacc and extension of the fimaNAc collaboration with a large pharma company.

The pivotal RELEASE study in bile duct cancer enrolled its first patient in May 2019. The study is initiated with up to two fimaChem treatments, based on the final confirmation of safety that was reached in April 2019 in the Phase I extension study. The overall survival data for Phase I patients receiving the pivotal study dose are encouraging, suggesting a clear improvement over the best comparable published data in this high-unmet need orphan indication. By mid-August 2019, regulatory and ethics approvals have been achieved in 9 countries including USA, with 15 European RELEASE study sites open for enrolment. Bile duct cancer has a higher prevalence in Asia and a feasibility study for selection of Asian sites has been initiated, with the aim to include Asian sites in 2020. 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 with potential accelerated approval at interim analysis.

The translation of the vaccination technology, fimaVacc, into humans was successfully completed in May 2019. 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. A recent preclinical publication in the high-impact immunology journal, Frontiers in Immunology, further elucidates the mechanism of action and prerequisites for the efficacy of T-cell responses induced by fimaVacc.

The fimaNAc research collaboration with a large pharma company was recently extended with six months to the end of December 2019 and thereafter the companies have agreed to use the following six months (until end of June 2020) to evaluate the potential for a further partnership. A positive international search report has been received on a patent application within the field of mRNA, which may generate valuable IP for the fimaNAc programme.

On the corporate side, the Scientific Advisory Committee has been further strengthened to ensure adequate scientific support for continued progress of the fimaVacc programme. The Board of Directors has by the appointment of Mrs Hilde Furberg been further strengthened with commercial experience and expertise.

Per Walday, CEO of PCI Biotech, comments: ”The initiation of the pivotal RELEASE study in inoperable extrahepatic bile duct cancer is progressing very well. The first patient was included in May and we now have regulatory and ethics approvals in two thirds of the countries including USA, and almost half of the planned sites open for enrolment and actively screening for patients. Additionally, a feasibility study is ongoing in Asia to ensure that we select and establish relationships with the most appropriate sites for patient recruitment and market impact. The company is now focused on successful completion of this transforming study. The encouraging fimaVacc Phase I results provide proof-of-concept and efficacy in terms of dosing in humans as well as an overall characterisation of tolerability. We will now use these data to guide further development in a clinical disease setting and in seeking partnerships. It was encouraging to receive the promising initial response on a patent application for mRNA delivery, which may prove highly valuable for the fimaNAc programme. We have also agreed a final six months extension of the current research collaboration with the undisclosed big pharma to complete in vivo work, including an additional six months thereafter for evaluation of potential next steps.”

Highlights –

fimaChem

*First patient enrolled in the RELEASE study

*Regulatory and ethics approvals for the RELEASE study achieved in two thirds of the planned countries, including USA

*Almost half of the RELEASE study sites opened and actively screening for patients

*Initiated feasibility study in Asia with the aim of including sites in 2020

*Completion of the full Phase I study, with successful safety read-out for repeated treatment

*Presented Phase I data at key conferences in Asia-Pacific and US

fimaVacc

*Successful clinical proof-of-concept with enhanced immune responses

*Preclinical publication in high-impact immunology journal (subsequent event)

fimaNAc

*Promising response on patent application for mRNA delivery (subsequent event)

*Final extension of the top-10 pharma research collaboration (subsequent event)

Corporate

*Further strengthened the Scientific Advisory Committee and the Board of Directors

***

A presentation in English will be held today, Wednesday 28 August 2019, at Oslo Cancer Cluster Innovation Park.

Time: Wednesday 28 August 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=98043175 ) 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 programme fimaChem consists of a pivotal 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 RNAi 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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