Are you seeking a non-animal, human tissue assay?
Have you found that your compounds have failed Phase 1 clinical trials due to adverse immune reactions/ rashes/ hypersensitivity ?
Do you currently carry out toxicology tests without including adverse immune reactions?
Does any of the above sound familiar? Alcyomics offer two tests, under the Skimune® platform, to solve these problems in the pharmaceutical industry.
Skimune®Pharm is a pre-clinical/clinical service tool using an in vitro skin explant assay. 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 personalized or stratified medicine.
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 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 test 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’ effect 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, including monoclonal antibodies, 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; it facilitates the product profile to support clinical trials.
Our tests use fresh whole blood and tissue from the same individual (autologous system) and can predict adverse immune responses caused by the test compound. See Case Study 1
The human based skin assay, Skimune®Mab addresses 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 development pipeline. The assay can be modified to client needs through our initial consultation service.
- Unique assay which uses human tissue therefore giving more informative results
- Reducing the need for animals within the industry and provides more informative results than the animal models
- Early identification and elimination of problem compounds during drug development pipeline
- Early identification of clinical failure due to adverse effects
- All of the above means you are saving both time and money
Please contact the team to find out more.