Evercyte

Intellectual Property of Evercyte

The development of novel therapeutics or the tests to proof the impact of new substances on toxicity and/or efficacy is labour and cost intensive. In order to improve pre-clinical testing and the generation of datasets as required by REACH of novel substances, it is therefore of high value to have as much as possible information on the future use and/or possible effects of new products. In addition, the 3R (reduction, replacement and refinement) strategy for animal trial replacement needs relevant and standardizable cell lines.

PharmacocellomicsTM

Evercyte has established the new concept of pharmacocellomics™ in the field of pre-clinical developments. Therefore, we will establish a cell bank of primary cells from different patients and tissues that are immortalized by telomerase or other strategies (SV40; SNEV) that we have established. In consequence, cell strains with the most similar phenotype to the primary cells will be available in sufficient amounts to perform reproducible preclinical drug testing. Since sufficient donors will be included for generating statistically meaningful data, general efficiency of the drugs will be estimated with high predictive power, also taking into account different genetic backgrounds. Therefore, drug development times and attrition rates till phase II clinical trials will be cut down markedly. However, immortalized cell cultures are also of high value as bioassays during production of drugs (from small molecules to biologics, biosimilars and biobetters), as sufficient cell numbers are guaranteed for reproducible testings during the lifetime of an API.

Toxicocellomics

Similarly, human cell panels are applied in the toxicocellomics approach, where cell panels for toxicity testing will be provided. Such cell panels might be integrated in already available test batteries in toxicity testing of chemicals including cosmetics or environmental toxins) in order to study and predict adverse outcome pathways (AOP) or modes of action.

Circumventing cellular senescence

Normal human somatic cells can only be propagated for a limited number of population doublings before entering a phase of irreversible growth arrest also termed replicative senescence. This phase is mainly due to progressive telomere erosion with each cell division. Since replicative senescence together with the restricted availability of specialized human normal cells limits the use of in vitro grown cells cells as in vitro test systems. Therefore, senescence has to be circumvented, which can be achieved by several strategies.

- Human telomerase

Evercyte makes mainly use of the technology of reactivation of human telomerase by overexpression of the catalytic subunit of this enzyme (hTERT). Additionally, if needed, overexpression of hTERT is combined with ectopic expression of viral oncogenes such as SV40 large T and small t antigens. Thereby, Evercyte succeeds in providing sufficient amounts of special human cell lines with characteristics of the normal counterpart cells that are found in vivo.

- Induced pluripotent stem cells

Besides the isolation, immortalization and characterization of human somatic cells, Evercyte has also developed a method for the generation of induced pluripotent stem cells from any consenting individual in a non-invasive form. Renal epithelial cells exfoliated into the urine can be reprogrammed into pluripotent stem cells by non-viral techniques. This method is advantageous in many circumstances, as the isolation of urinary cells is simple, cost-effective and universal.

Evercyte produces and delivers…

• single immortalized cell strains incl. mesenchymal stem cells and urine-derived iPS cell lines that can be differentiated into any cell type of the three germ layers,

cell panels incl. cell strains of different tissues and/or specific donors (healthy, diseased, treated, young, old, male, female, etc.),

customer-tailored cell lines,

cell based assay and CRO services.