PCI BIOTECH HOLDING ASA 2
LEVERAGING THE PCI TECHNOLOGY PLATFORM WITHIN IMMUNOTHERAPY & NUCLEIC ACID THERAPEUTICS
ABOUT PCI BIOTECH
PCI Biotech is a biopharmaceutical company headquartered in Norway and listed on the Oslo Stock Exchange. The company develops novel therapies and new technologies through its proprietary photochemical internalisation (PCI) platform technology originating from world-leading research at the Oslo University Hospital - the Norwegian Radium Hospital. The PCI technology works by inducing light-triggered endosomal release, which may unlock the potential of a wide array of modalities.
The fimaNAc programme utilises the proven capability of the PCI technology for intracellular delivery of nucleic acids. The technology can be used for most types of nucleic acids, ranging from oligonucleotides through mRNA and plasmids to viral vectors. The development of the fimaNAc programme is currently focussed on selected applications within dermatology and bioprocessing that are well suited to the specific strengths of the PCI technology. The fimaVACC programme aims to enhance immunotherapy in cancer by triggered endosomal release of antigens or nucleic acids encoding antigens, or immunostimulatory factors. In preclinical experiments, fimaVACC has demonstrated excellent efficacy with protein- and peptide-based vaccines, with particularly strong cytotoxic (CD8) T-cell immune responses, which are crucial in cancer immunotherapy. The beneficial immune characteristics of fimaVACC have been successfully verified in humans through a Phase I study with healthy subjects.
KEY FIGURES
(In NOK 1,000) | 2023 | 2022 | 2022 | ||||
Q1 | Q1 | FY | |||||
Other income | 232 | 1 188 | 4 750 | ||||
Operating expenses | 6 611 | 23 988 | 61 197 | ||||
Operating results | -6 379 | -22 801 | -56 447 | ||||
Net financial result | 423 | -212 | 1 352 | ||||
Comprehensive income | -5 956 | -23 012 | -55 095 | ||||
Cash & cash equivalents | 51 121 | 93 680 | 56 596 | ||||
Cash flow from operating activities | -5 364 | -21 592 | -59 041 |
www.pcibiotech.com
3
H I G H L I G H T S
fimaNAc
bioprocessing and dermatology
The bioprocessing program for use of fimaNAc in gene therapy
manufacturing has generated new results that add to the initial patent application filed in 2H 2022. Upcoming work will focus on generating results that can trigger testing with potential customers to get feedback and develop a competitive technology.
The run-in phase of the
dermatology project to demonstrate topical fimaNAc- mediated nucleic acid delivery in a preclinical wound model is ongoing. Readout is expected to be reported in the Q2 2023 interim report. Positive results will be utilised for seeking co- development with partners having therapeutic nucleic acid-based candidates.
fimaVACC
intratumoural immunotherapy
PCI Biotech is exploring
approaches aimed at identifying novel immunotherapy treatment combinations, and a patent application for an undisclosed treatment approach was filed in Q1 2023.
CORPORATE
The cash position of NOK 51 million
enables a financial runway towards the end of 2024 with current plans.
www.pcibiotech.com
4
PIPELINE
Programme | Description | Preclinical | Phase 1 | Phase 2 | ||
fimaNAC | Dermatology | |||||
fimaVACC | Intratumoural immunotherapy | |||||
Collaborations | Various | |||||
Programme | Application | Feasibility | Prototype Commercial | ||
fimaNAC | Bioprocessing | ||||
OPERATIONAL REVIEW
BIOPROCESSING - MANUFACTURING OF BIOLOGICAL DRUGS
Bioprocessing is the manufacturing of biological drugs, which involves complex processes that are bottlenecks in the endeavor to offer breakthrough therapies to new and larger patient populations. Development of technologies for use in bioprocessing is less complex from a regulatory perspective compared to clinical development of new therapies, allowing shorter timelines and lower costs.
fimaNAC | There is a great need for technologies that enable more effective bioprocessing |
with higher yield as well as increased quality at a lower cost, and in 2022, PCI | |
Biotech initiated a project aimed at using fimaNAc for solving these challenges | |
in gene therapy manufacturing. | |
During Q1 2023, new internal data have been generated to strengthen the first | |
patent application filed in 2H 2022. We continue to advance the application to | |
generate proof-of-principle data in a small-scale system. | |
The positive initial external feedback on fimaNAc's value proposition was | |
further confirmed during the BioEurope Spring event in March, warranting | |
further studies working towards alpha testing with potential customers. |
www.pcibiotech.com
5
DERMATOLOGY
Nucleic acid therapeutics have the potential to improve treatment of | |
dermatological diseases, but delivery remains an obstacle. This is a challenge | |
fimaNAc is uniquely positioned to solve, by achieving site-directed intracellular | |
delivery. PCI Biotech has initiated a project aimed at developing an easy-to-use | |
topical formulation for efficacious delivery of nucleic acids using fimaNAc. | |
fimaNAC | The first development phase aims to demonstrate fimaNAc-mediated nucleic |
acid delivery in an ex vivo wound model with topical administration. The study is | |
performed by an expert contract research organisation. The run-in part of the | |
study is ongoing, and readout is expected to be reported in the Q2 2023 interim | |
report. Positive results may provide opportunities for early-stage collaborations | |
with partners developing therapeutic nucleic acid candidates. |
INTRATUMOURAL IMMUNOTHERAPY
PCI Biotech is exploring intratumoural immunotherapy approaches within the | |
fimaVACC program, aiming at identifying novel treatment combinations to | |
overcome resistance to immune-checkpoint inhibitors and safety-issues | |
associated with such treatments. fimaVACC is a technology designed for local | |
enhancement of therapeutic effects and is well suited for delivery of immune | |
stimulants to tumour sites. As such, the technology can enhance the delivery of | |
peptides, proteins, nucleic acids, small molecules, and viral vectors, all of which | |
fimaVACC | are relevant for locally administered immunotherapy. |
A patent application for an undisclosed treatment approach was filed in Q1 | |
2023. A Ph.D. candidate grant of up to NOK 2.5 million over 3 years, | |
commencing 1st January 2023 and dedicated to the development of | |
intratumoural immunotherapy, has been granted by the Research Council of | |
Norway, |
www.pcibiotech.com
Attachments
- Original Link
- Original Document
- Permalink
Disclaimer
PCI Biotech Holding ASA published this content on 12 May 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 12 May 2023 05:12:13 UTC.
