Skimune®Pharm is a pre-clinical/clinical service tool. It is designed to predict first in-man immune or allergy responses for new therapeutics but also efficacy testing for personalized or stratified medicine. Skimune®Pharm is a human in vitro skin explant assay which uses fresh whole blood and tissue from the same individual (autologous system) to predict allergic responses. We use healthy donors with informed consent and generally recommend a minimum of four tests (four individuals) to determine safety responses and allow for inter-individual variability. However, to aid your project and to answer your specific questions we offer a Unique Service. Tests can be carried out on a range of concentrations (dose-response assessment). Skimune®Pharm gives a unique histopathology potency readout graded according to the severity of skin damage.
The Skimune®Pharm assay determines if the test drug has the potential to cause an allergic response. The assay shows if the test drug can elicit damage in the skin, which is a unique method of determining the immunogenic characteristics of the test drug.
As an additional service we can measure T cell proliferation responses, which can give further insight into the activation and expansion of T cells and the level of cellular response to the drug. We can also measure cytokine release ( eg Interferon gamma) which can aid in determining if a ‘cytokine storm’ effect occurs in response to the test drug.
Alcyomics have developed a human in vitro skin explant assay (Figure 1) to determine efficacy, potency, dose responses and immunogenicity of therapeutics, including monoclonal antibodies, biosimilars and aptamers. Our tests are carried out on fresh human tissue taken from healthy donors. The compound of interest is incubated with peripheral blood mononuclear cells and skin tissue from the same donor and can predict allergic responses or adverse reactions caused by the test compound.
The assay addresses several problems of the use of animal models as surrogate humans for safety testing such as, the selection of a relevant animal species for safety testing, disparity in safety responses related to interspecies differences and effectiveness of safety responses of novel therapies tested in animals compared to humans. It can be used as a valuable tool for pre-clinical testing by bridging the gap between animal testing and first-in-man and facilitates product profile to build support for clinical trials. The assay is an economical in vitro test to determine any unintentional reactivity or cytoxicity towards the human immune system and is suitable to determine dose range or to investigate single dose or repeat dose responses and or efficacy.
We can provide our client with reliable and accurate data to remove risks associated with product development and help in making decisions about product candidates. The assay can be modified to client needs and involves testing antibodies or novel therapies in Skimune®Mab for immunogenicity and efficacy together with the appropriate controls. All skin samples are collected at the end of the assay and routinely sectioned and stained for histopathological damage. The reports evaluate the effect of the therapeutics on immunogenicity and the immune response.