News

In North America: Tuesday 8^th October 2019 at 12:00 PM EDT/ 9:00 AM PDT

In Europe:  Tuesday 8^th October 2019 at 12:00 PM BST/ 1:00 PM CEST

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Abstract:

There are currently limited reliable human in vitro assays which test for sensitization, immunotoxicity and efficacy of novel compounds that are equivalent to in vivo animal testing. Here we describe a novel test named Skimune® developed as a non-artificial (non-3D) human in vitro assay which can predict adverse immune reactions. The test uses blood and skin biopsies taken from healthy volunteers and gives a predictive readout of skin damage which strongly correlates with screening assays such as inflammatory cytokine release and T cell proliferation responses. The data from the different assays is integrated to provide a precise report of the potential risk of the test compound to induce adverse reactions. The Skimune® tests allow the study of immune responses in the presence of chemicals, cosmetics and drugs such as monoclonal antibodies, small molecule drugs and also cellular therapies.

Skimune® has been shown to correctly predict the sensitizing capacity of chemicals with 95% sensitivity, 95% specificity and 0.96 correlation to the gold standard mouse local lymph node assay (mLLNA). The test proves to be a reliable non-animal alternative test for sensitization studies of chemicals, cosmetics and household products.  Additionally, the Skimune® technology offers a preclinical tool which can accurately predict allergic responses to new therapeutics (biologics and small molecule drugs) (r=0.86, p=0.001) before testing in man. We tested therapeutic biologics, including a TGN1412 monoclonal antibody analogue, with promising results. The test could have predicted the serious life-threatening cytokine storm which affected healthy volunteers in the 2006 Northwick Park trial. The Skimune® technology allows for early detection of adverse events allowing improved development of therapeutic drugs and compounds and aid in the safety profiling or hazard risk of compounds. Recent advancement in this technology has led to the development of a Skimune® 3D skin equivalent model.  The Skimune® 3D skin equivalent model is a fully human full thickness autologous model which can be used for similar tests as the non 3D Skimune® model, but on a large-scale capacity, enabling fast throughput screening and contributing to vast savings in development time and costs of advancing new products to the market shelf.

About the speaker:

Dr Ahmed graduated as a molecular biologist and then continued her interest in science by successfully completing a PhD in the Department of Clinical Medical Sciences at Newcastle University in 2006. Following her interest in translational medicine, Dr Ahmed went on to work in Haematological Sciences in the field of bone marrow transplant biology before making a successful transition from academia to industry. She is currently utilising her expertise at Alcyomics Ltd, a spin-out company from Newcastle University, to help provide a service provision for safety testing of biologics and cosmetics, where she holds the position of Scientific Manager.

Dr Ahmed has broad research interests based around immunogenicity, allergy and skin explant biology with specific research interests in T lymphocyte stimulation and cytokine release in response to sensitizing chemicals and respiratory allergens, drugs and novel compounds. Dr Ahmed also has active interests in the development, validation and application of novel predictive test methods, including 3D models and bio-printed models, which aim to reduce, refine and replace the use of animals in safety assessment.

Dr. Shaheda Ahmed

Scientific Manager, Alcyomics Ltd