Our team is working on three innovative projects that showcase the versatility and benefits of our K-One® technology across various applications. These projects are led in collaboration with top-notch partners in their respective fields and have been awarded national grants from the French Public Investment Bank, Bpifrance.
While immunotherapies have now proven their efficacy in activating the immune system to fight against targeted conditions (such as cancers and immuno-inflammatory chronic diseases), some of these treatments can generate Anti-Drug Antibodies (ADAs). ADAs represent an immune response from the patient directed against the therapeutic antibody, which can impact the clinical effectiveness of the treatment.
Current testing methods are reliable for detecting high concentrations of ADAs but become insufficient when it comes to detecting them early at low concentrations, an issue known as low drug tolerance. Early detection of ADAs is crucial for making informed therapeutic decisions as swiftly as possible, enabling adjustments to the treatment plan, such as stopping, adapting the dose, or switching treatments if possible.
Leveraging our proprietary coating technology on gold nanoparticles, we are developing an innovative method to enable early detection of ADAs by enhancing the drug tolerance of current assays. In collaboration with experts in the field from Paris-Saclay University and Institut Gustave Roussy, our method is undergoing testing on several therapeutic antibodies used in rheumatology and oncology, paving the way to tomorrow's ADAs testing.
The Covid-19 pandemic has highlighted the need for reliable, low-cost, rapid, and decentralized diagnostic tests, facilitating the swift isolation of infected individuals and limiting contamination across the entire population. While Lateral Flow Assays (LFA) and Polymerase Chain Reaction (PCR) were extensively developed and utilized, each had its drawbacks (a lack of reliability for the former and issues related to cost, time, and infrastructure for the latter). In this context, LAMP-based assays gained prominence.
'LAMP' stands for ‘Loop-mediated isothermal AMPlification’, a DNA/RNA amplification technique that is quicker (40 minutes compared to 90 minutes) and simpler (eliminating the need for thermal cycling) than conventional PCR assays. When combined with a Lateral Flow Assay for visual result interpretation, numerous LAMP-LFA tests were developed to combat Covid-19. However, these tests were not close enough to PCR assays' sensitivity, nor did they reduce costs to the level of LFAs.
By merging our coated gold nanoparticles with innovative biologics from our partner, the Laboratory of Biology and Applied Pharmacology (CNRS/ENS Paris-Saclay), we are pioneering a new LAMP-LFA diagnostic method. This approach narrows the gap to PCR assays in terms of reliability while approaching the cost-effectiveness of LFAs. Initially tested on two different models, including Covid-19, our adaptable method can be swiftly modified to target any disease type.
The number of cell or gene-based innovative therapies under development or already on the market has drastically increased over the past decade, although their adoption remains limited due to cost constraints. One key challenge to overcome in making them affordable and available for all patients is improving the production yield. This requires the use of the right analytic tools to better understand the mechanisms at work within the bioreactors.
Existing analytical controls are mostly carried out off-line and at the end of the production process. These approaches are insufficient to ensure reproducible cell cultures in bioreactors, leading to significant economic losses as entire batches must be discarded in case of negative functional controls.
Our SEQRET project aims to bring reliable analytical capabilities to where cell therapy companies need them most: during production. Partnering with experts in cell culture process optimization (LRGP laboratory), clinical-grade stem cell therapy production (Nancy Hospital), and biosensor development (PhaseLab Instruments), we are developing an at-line quality control device. This device is capable of detecting biomarkers directly in culture supernatants, allowing for the real-time optimization of culture conditions and minimizing the risk of batch failures.
If you are interested in discussing a potential research partnership with Kimialys, reach out to our team.