Oslo (Norway), 27 November 2019 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company today announces its third quarter 2019 result. Please find enclosed the report and presentation.
*Start-up activities for the RELEASE study are progressing well after the study commenced with enrolment of the first patient in May 2019
*23 out of 40 planned clinical sites had opened for enrolment by mid-November. While this is 10 sites less than planned and causes a temporary effect on patient recruitment projections, the company expects site activations to be back on track early 2020. The overall RELEASE study timelines are maintained
*The first US site was activated only recently and enrolment of the first US patient may therefore slide into 1H 2020
*Site selection is ongoing for addition of sites in Asia in 2020, to provide access to hospitals and key opinion leaders in a region with higher prevalence of bile duct cancer and to enhance patient recruitment
*Phase I results have been accepted for presentation at ESMO Immuno-Oncology Congress in December 2019. The results provide proof-of-concept of the fimaVacc vaccination technology by demonstrating the improvement of immunogenicity in healthy volunteers
*Development strategies are being pursued in parallel, with Phase I results being used both in direct partnering efforts and planning for clinical proof of concept in a disease setting
*Preclinical study published in high-impact immunology journal Frontiers of Immunology, demonstrating that therapeutic cancer vaccination with fimaVacc can be effective independent of T-helper cell functionality
*Research collaboration with AstraZeneca was extended by six months until end of 2019. The scope has been expanded to evaluate if synergies established in oncology are transferrable to additional disease areas – further collaboration to be evaluated in 1H 2020
*Promising response on patent application for mRNA delivery, which may generate valuable intellectual property
Throughout the third quarter we have continued to execute against the strategic goals we set for ourselves early in the year. The start-up activities of our RELEASE trial are progressing, and we maintain the overall timelines we have indicated for the trial. The current lag in site activation in this early phase of the trial is expected to be resolved early next year and the inclusion of Asian sites in 2020 is expected to secure patient recruitment projections, comments Per Walday, CEO of PCI Biotech.
In parallel we continue to lay the groundwork for expanding our fimaVacc and fimaNAc technology platform programmes. The positive initial feedback on an important patent application on mRNA delivery and the expansion of the collaboration with AstraZeneca are both encouraging developments for fimaNAc. This progress has been matched with an organisational expansion and we look forward to further enhance our strategic execution capabilities in the coming quarters, adds Walday.
November 2019, at Oslo Cancer Cluster Innovation Park.
Time: Wednesday 27 November 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 https://webtv.hegnar.no/presentation.php?webcastId=98164537 ) 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 late stage clinical development 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.
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.