Are you seeking a non-animal, human in vitro skin assay?
Have you found that your compounds have failed Phase 1 clinical trials due to adverse immune reactions/ rashes/ hypersensitivity/immunotoxicity ?
Do you currently carry out toxicology testing without additional assessment of adverse immune reactions?
Does any of the above sound familiar? Alcyomics offers two tests, under the Skimune® platform, to solve these problems for the pharmaceutical industry.
Skimune®Pharm is a pre-clinical/clinical service tool using a human in vitro skin explant assay.It focuses on non-animal clinical and preclinical in vitro testing designed to predict adverse immune responses to novel therapeutics.
It is designed to predict first in-man adverse immune responses to large (eg monoclonal antibodies) and small novel therapeutics (as shown in Case Study 3) as well as efficacy testing for personalised or stratified medicine approaches.
The Skimune®Pharm assay involves the use of fresh whole blood and tissue from the same individual (autologous system) to predict adverse responses; traditional assays are purely cell based. The assay has also been used to assess the efficacy of novel immunomodulators and safety assessment for cellular therapies. (Qesari M, Richter A, Ogonek J, Mischak-Weissinger E, Wang XN, Dickinson AM. Cytomegalovirus-Specific T Cells Isolated by IFN-γ Secretion Assay Do Not Induce Significant Graft-Versus-Host Reactions In Vitro. Transplantation. 2016 Nov;100(11):2352-2361).
As a screening tool we 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 also measure cytokine release (eg Interferon gamma) which can aid in determining if a ‘cytokine storm’ or Cytokine Release Syndrome (CRS) occurs in response to the test drug.
The service that we offer is a unique package specifically designed to meet your requirements, we can design your study with a number of tests from different individuals to determine safety responses and allow for inter-individual variability. To find out more how Alcyomics can help you please contact us.
Alcyomics Skimune®Mab was developed to determine efficacy, potency, dose responses and detection of adverse immune responses to biologics, i.e. monoclonal antibodies (including their aggregated format), biosimilars and aptamers. It can be used as a valuable tool for pre-clinical testing by bridging the gap between animal testing and first-in-man studies; it facilitates the product profile to support clinical trials.
The human based skin assay, Skimune®Mab solves several problems of the use of animal models for safety testing such as:
- The selection of a relevant animal species,
- Disparity in safety responses related to interspecies differences,
- Effectiveness of safety responses of novel therapies tested in animals compared to humans.
We can provide our client with reliable and accurate data to remove risks associated with product development and help in the decision making process about product candidates during the drug development pipeline. The assay can be modified to client needs through our initial consultation service.
For an example See Case Study 1
- Unique assay which uses human tissue
- Reducing the need for animals within the industry and provides more informative results compared to comparative animal models
- Early identification and elimination of problem compounds during the drug development pipeline
- Early identification of clinical failure due to adverse immune reactions
- All of the above saves you both time and money
Please contact the team to find out more.