Currently ‘undruggable’ diseases may soon have therapies
Most pharmaceuticals on the market today are small molecule drugs, synthetic chemicals with low molecular weight. Over the last few decades, growing emphasis has been placed on finding innovative therapeutic products outside this realm for currently ‘undruggable’ targets. A new era of therapies has emerged, harnessing proteins, other biomolecule-based constructs and nanoparticles. These innovative therapeutics are highly complex in preparation, structure, administration and modes of action. Many are difficult or impossible to analyse with current technologies for issues such as how they behave under different conditions and how strongly they bind their targets. The EU-funded FIDA project has brought a pioneering solution to market. Its patented flow-induced dispersion analysis (FIDA) platform enables fast, direct, reliable quantitative measurements and analysis of complex next-generation therapeutics under native conditions.
FIDA and first principles for immunological measurements
Proprietary FIDA technology requires just a few microlitres of sample (up to 16 times less than current methods require) to provide an array of validated, quantitative data about binding affinity, aggregation, conformational changes, sample integrity and more. It does so within minutes. Altogether, users get more reliable data and operational costs are reduced more than 60 %. According to Brian Sørensen, Chief Executive Officer of project coordinator Fida Biosystems, “FIDA is the only versatile technology on the market based on first principles – no underlying assumptions, just direct links between measurements and data. In-solution, first-principles technology enables you to get insight that cannot be gained with existing indirect technologies. It is the unparalleled way to analyse new drugs for important diseases that are undruggable today.”
Optimising FIDA: pilots at big pharma, biotech and research institutions
Over the course of the three-year project, the team successfully analysed a wide range of new drug designs. These included therapeutic exosomes, membrane proteins, adeno-associated viruses, proteolysis-targeting chimaeras, molecular glues, bio-condensates, aptamers and multi-specific monoclonal antibodies. In addition to completing the hardware platform and the software tools, the project enabled the team to run an impressively large number of pilots with big global pharmaceutical companies, front running biotech companies and internationally leading research institutions. “The more than 100 pilots have been an invaluable real-life validation of the technology. They enabled us to develop a strong portfolio of applications addressing key drug development challenges. Anyone working with ‘science-to-business’ should make sure to involve real end users from the earliest stages,” advises Sørensen. This interest between industry and academia in testing FIDA technology on their challenging systems, and their positive feedback on results and the ease of use, far surpassed the original project goals.
Accelerating FIDA market penetration and visibility
“Integration of technology optimisation and commercialisation development makes the H2020 Fast Track to Innovation programme extremely efficient at getting new technology to market,” states Sørensen. FIDA is proof of that – from the project start to date, the company has sold 37 FIDA platforms, half of those since January 2022. Based on the accelerating penetration, Sørensen estimates the company will double sales by the end of next year. This will benefit the companies that use the platforms, the patients whose once untreatable diseases have new therapies and the competitive position of Europe in this multibillion-euro market sector.
Keywords
FIDA, flow-induced dispersion analysis, first principles, biomolecule, nanoparticles, next-generation therapeutics, proteins, undruggable, antibodies, small molecule drugs
