Oslo (Norway), 26 February 2020 – PCI Biotech (OSE: PCIB), a cancer focused biopharmaceutical company, today announces its interim fourth quarter and preliminary 2019 results. Please find enclosed the report and presentation.
2019 in review – focus on execution of the pivotal RELEASE study
The overall survival data for Phase I patients receiving the pivotal fimaChem study dose are encouraging. Although it is a small sample size the results suggest a clear improvement over the best comparable published data in the high unmet need orphan indication, bile duct cancer. During the year the results were presented at key conferences in Asia-Pacific and US. Final confirmation of the safety milestone of up to two fimaChem treatments was reached in the Phase I extension study in Q2 2019 and focus since then has been on start-up activities for the pivotal RELEASE study with registration intent. The first RELEASE study patient was enrolled in Europe in Q2 2019, but a delay in the opening of study sites was experienced during 2H 2019. The first US study site opened in Q4 2019, which pushed enrolment of the first US patient into 2020. Opening of sites is not yet back on track, and study recruitment and projections are currently behind the original plan. The company has therefore activated several additional initiatives to recoup long-term patient recruitment projections, with the aim to reach interim analysis by Q2 2022.
The translation of the fimaVacc vaccination technology into humans was successfully completed in Q2 2019 and the results were presented at ESMO Immuno-Oncology in Q4 2019. The results of the Phase I study provide proof-of-concept by demonstrating improved immunogenicity of vaccines in healthy volunteers. The patent focused work initiated in 2013-2014 has started to generate results, providing additional IP protection for the development program. The development focus is two pronged; utilising the Phase I results in partnering efforts and planning for clinical proof-of-concept in a disease setting.
The collaborative fimaNAc programme continues its positive development, and the collaboration with AstraZeneca was extended and expanded during the year. The company received promising response on a patent application for mRNA delivery and a granted patent can provide valuable IP for fimaNAc.
On the corporate side, the Scientific Advisory Committee has been further strengthened to ensure adequate scientific support for continued progress of the fimaVacc programme.
Per Walday, CEO of PCI Biotech, comments: “It is reassuring to see encouraging finally confirmed survival data from the fimaChem Phase I study with a median overall survival in Cohort 4 of 22.8 months, which is almost twice that seen in the ABC-02 study that established gemcitabine and cisplatin as standard treatment in cholangiocarcinoma. Our full focus is now on the effective completion of the pivotal RELEASE study with registration intent. We have unfortunately experienced delays in the opening of sites in the start-up phase of the study, but we are confident that new recruitment initiatives will increase patient enrolment. The presentation of the encouraging fimaVacc Phase I results at ESMO Immuno-Oncology Conference in Q4 2019 paves the way for further development of this programme, supported by broad patent protection including the recent fimaVacc patent granted in the US.”
Highlights in the quarter
*The encouraging early results on survival from the Phase I study in inoperable extrahepatic bile duct cancer have been quality checked and finally confirmed to a median overall survival (mOS) of 16.1 months for the full study; 22.8 months for the highest dose cohort (Cohort IV); and 16.6 months for the extension study
*Seven new RELEASE study sites have opened since the Q3 report and 30 out of the 40 initially planned sites were open for enrolment by mid-February 2020. This is 8 sites less than planned and patient recruitment and projections are currently behind the original start-up plan. Several new initiatives to recoup long-term recruitment projections are being implemented, with the aim to reach interim analysis by Q2 2022
*The two first US sites were open by mid-February 2020, with more sites lined up for activation during 1H 2020 and awaiting enrolment of the first US patient
*Site preparations are ongoing for addition of Asian sites in 2020, to provide access to hospitals and KOL’s in a region with higher prevalence of bile duct cancer and to enhance patient recruitment
*The primary endpoint of the interim analysis in the RELEASE study will be changed to objective response rate following a post-IND recommendation by the FDA. This modification is not expected to impact the estimated timelines
*Phase I results were presented at the 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
*A two-pronged development strategy is pursued, with Phase I results being used both in direct partnering efforts and planning for clinical proof of concept in a disease setting
*US patent granted in January 2020 with broad coverage for the combination of fimaVacc with various cytokines
* The scope of the research collaboration with AstraZeneca was expanded to evaluate if synergies established in oncology are transferrable to additional disease areas – further collaboration to be evaluated in 1H 2020
A presentation in English will be held today, Wednesday 26 February 2020, at Oslo Cancer Cluster Innovation Park.
Time: Wednesday 26 February 2020, 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://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20200226_1 ) or the company’s website under “Investors – Reports and presentations – Webcasts”. It will be possible to post questions through the webcast console.
For further information, please contact:
Ronny Skuggedal, CFO
Mobile: +47 9400 5757
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.
For further information, please visit: www.pcibiotech.com
PCI Biotech Holding ASA, Ullernchausséen 64, N-0379 Oslo
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.