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Scale-up of our disruptive antibody analytical platform based in flow-induced dispersion analysis (FIDA) to increase efficiency in the research of new antibodies and vaccines

Periodic Reporting for period 2 - FIDA (Scale-up of our disruptive antibody analytical platform based in flow-induced dispersion analysis (FIDA) to increase efficiency in the research of new antibodies and vaccines)

Reporting period: 2020-12-01 to 2022-05-31

In the last decades, a growing emphasis has been on finding effective therapeutic products against major diseases within oncology, CNS, immunology etc. outside the realm of traditional small molecules. In 2017, just monoclonal antibodies had total sales worth €83.8bn. In the recent years, the range of non-small molecule candidates has widened. Thus, today significant resources are invested in new modalities and new modes of actions, e.g. polyclonal antibodies, PROTACS and similar targeted protein degradation models, incl. AbTACs, AAVs, exosomes, nanodiscs, nucleotide-based vaccines, conformational changing molecules, aptamers and other nanoparticles etc. In targeted protein degradation alone, over USD 3.5bn was invested and +90 high value licensing deals were inked since 2014. In Q3 2019, investment in this area accounted for 35% of the total investment, and it is anticipated to grow at an annualised rate of over 30%.

These new entities, incl. antibody-based drugs are complex in construct and administration.

Being based on relative signal changes in parameters assumingly linked to biological and molecular reactions, current technologies used for functional characterisation and quantification were not designed to fully address the efficacy and safety issues of these new drug modalities and thereby. I.e. research in industry and academia in this area are often held back by suboptimal data based on assumed correlations.

Our overall objective is to provide a technology that can enable researchers to push their research within the broad range of proteins, other biomolecules constructs and nanoparticles beyond the current boundaries to allow society to take full advantage of these new therapeutic models.

With fast, direct, quantitative measurements and an ability to analyse proteins and large complex nanoparticles up to 1,000 nm in diameter incl. viruses, exosomes, liposomes, membrane structures etc., the FIDA technology holds a unique potential of addressing these needs. With just a few microliters of plasma, serum, fermentation media etc., without purification, additional to immunogenicity, the technology provides researchers with an array of validated, quantitative data about binding affinity, stoichiometry, aggregations, integrity, oligomerisation, multiple binding, conformational changes, etc.
Based on the effects of the Corona lock-down, the Commission has granted a 6 months’ extension of the project period.

Despite the Corona obstacles, it has been possible to achieved significant results during the first 12 months.

Initially, a new communication plan was established. Hereupon, amongst other, the technology was presented at 8 international conferences, a new website was launched, an inhouse seminar with three end-user presentations and +35 external participants held, the company name was changed from Fida-Tech to Fida Biosystems (Fidabio). The above was achieved prior to the Corona lock-down. To compensate for the cancellations of physical conferences from March 2020 and onwards, online communication activities were increased, which amongst others included 3 virtual conferences.

Regarding the instrument platform, it has been possible to push forward on the finalization of the first standard product configuration with 480 nm fluorescence detection and with a dedicated proprietary Fidabio software suite for assay design, instrument control, data analysis and report generation. To support new applications within the project scope, partner Elvesys has developed the first prototype of a new advanced pressure control.

Though delayed by the Corona situation, partner NVT has during the first 12 months established a thorough, initial market survey and has, in close collaboration with the FIDA commercial team, generated an initial pipeline of potential industrial and academic customers.

So far, this has led to an install base of 9 instruments, of which 7 is sold to leading external research and industrial entities across the world based on comprehensive prior validation experiments.

Furthermore, the market initiatives have provided additional + 30 FIDA technology pilot projects carried out on customer premises, and in the FHWN and the Fidabio laboratories, for research institutions and companies primarily from Europe and the US. One of these projects is carried out in collaboration with a university hospital involving [..] patient samples.

Though there are still significant application development work pending, FIDA and partner FHNW have through the first period developed an initial portfolio of applications showcasing and proving the uniqueness of the FIDA technology, amongst others applications for characterization of liposomes, determination of oligomeric state, analysis of ternary complex formations and ubiquitination in targeted protein degradation, determination of conformational changes, quantification of exosomes and IgG in crude matrices, quantification of corona antibodies directly in blood serum etc.
There are existing technologies available for characterization and quantification of proteins and bioparticles and many are proven and verified in multiple areas. However, when working with complex modalities, e.g. multi-unit constructs and large particles, much research in industry and academia is based on assumed correlations.

The FIDA technology provides a unique ability to gain new insights when working with or administrating such complex modalities with respect to efficacy and safety, which is amongst others essential for the management of underlaying immune responses.

A key element in this respect is the ability to determine quantity, functional interactions and integrity based on quantitative measurements of the size and the change in size of the molecules or the particle.

Amongst the more significant achievements during the first 12 months, there are now customer acknowledgements of the proprietary Fidabio platform being the preferred technology for 1) rapid and accurate full determination of oligomeric state in near-physical conditions, 2) detailed quantification and integrity assessment of specific large exosome participles for therapeutic use and 3) characterization of polyclonal antibodies in crude matrices.

At the end of the project, it is expected that there the set goals are met. Amongst others, it is recognized by leading research and industry communities that the FIDA technology is a highly reliable and cost-effective platform for providing new insights in R&D involving biomolecules and particles, incl. antibodies, vaccines etc. essential for advancing the utilization of new biologic agent in the treatment of major diseases. The offering will comprise already established applications as well as an array on new applications.

In addition, this will provide significant cost reductions in drug development and as a consequence of more efficient safety analyses, there will longer term be a healthcare savings, incl. savings in HSR costs.