Drug safety is imperative in any drug development. Drug developers strive to exclude any measurable adverse effects of their products on the patient. To maximize accuracy in toxicology studies, new drugs are traditionally tested on animals. It is an uncircumventable and unresolved ethical dilemma, as no alternatives exist.
Any adverse effects are examined extensively before reaching the first stage of testing in humans. Even so, studies show that 20% of all drugs tested on humans show unexpected toxicity. This shows an inaccuracy in today’s toxicity screening, resulting in a waste of time, money and animal suffering. Current methods also face a problem in identifying longer-term adverse effects and in particular subtle changes to the epigenetic landscape of cells that could permanently alter gene function.
At Epigenica, our mission is to increase the level of accuracy and safety in drug development and reduce the time needed for drug development processes. We believe epigenetics is an emerging area of toxicology. Our solution allows profiling of many epigenetic markers at the same time and identifies when changes occur as part of early cell-based drug development and toxicology. Our technology is compatible with many state-of-the-art human toxicology models including organoids or liver-on-a-chip. Based on human cells, those assays are powerful predictors of the outcome in clinical studies. We believe our technology will help to greatly reduce costly and unethical animal experiments as it can potentially discover drug toxicity in earlier stages.
Beyond genetic alterations, cancer cells are known to exhibit abnormal epigenetic signatures that are targeted by an emerging class of epigentic cancer drugs (HDAC inhibitors, BRD4 inhibitors). Epigenetic cancer drugs have been successful in circumventing resistance and relapse of cancers after traditional treatments.
Studies have also revealed key roles of epigenetic processes in regulating immune cell function and mediating antitumor immunity. The emergence of immunotherapy as a treatment to cancer has revolutionized the management of many types of cancer but most patients do not have a response or become resistant to the treatment. The combination of epigenetic drugs and immunotherapy is emerging as a crucial therapeutic paradigm across a variety of malignancies.
Epigenica’s tool for tracking the epigenetic landscape can greatly increase the speed of which the epigenome response is evaluated. The technology allows drug developers to widely and accurately see the response of the cancer cell epigenome but also the off-target effects on other healthy human cells. The tracking of a patient’s epigenomic profile enables a new level of personalized medicine, which can result in tailored therapy by evaluating the individual cancers epigenetic signatures and predicting or testing the drug response in patient derived cells.
With modern technology, the collection of biological big data has become a fruitful field of study. Personalized wellbeing could prove a big success in medicine if early signaling for diseases is discovered. Following cohorts of healthy people over years allows scientists to track large volumes of medical markers before and during the earliest manifestations of aging and disease. Longitudinal epigenomic studies could show how epigenetic profiles change during the development of the disease and give us clues to what signatures help to predict the fate of healthy patients. Our technology allows broad sampling of epigenetic markers at low cost, making longitudinal tracking of individual epigenomes feasible.