First ex vivo human skin platform investigating ISR launched
pharmafile | July 7, 2021 | News story | Research and Development |
Genoskin has announced the launch of ISR Platform, a novel pre-clinical toolbox designed to study injection site reactions (ISR) in humans, ahead of clinical trials.
The ISR Platform enables the development of safer new biologics by characterising mast cell-dependent (pseudo-allergy) or -independent inflammatory skin adverse events.
Subcutaneous injected biologics are a key part of current pharmaceutical developments but are subject to side effects. Patients commonly experience moderate to severe reactions at the site of injection, including swelling, erythema, pruritus, or pain. All biologics can lead to injection site reaction, which is the most reported adverse effect.
Therefore, the current lack of research tools to study injections in humans makes development of such therapeutic molecules very challenging, especially when animal testing is the only option for companies.
The ISR Platform will provide researchers with a new turnkey solution, enabling the testing of subcutaneous biologics in ready-to-use, standardised, fully immunocompetent and injectable ex vivo human skin models. Based on living and healthy human skin, the platform maintains the tissue in a functional survival state for at least seven days, and also incorporates technology that allows the culture of human primary mast cells.
Pascal Descargues, PhD, CEO of Genoskin, said: “Imagine the possibilities now that we can characterize what happens in a human without using an actual patient. Our biotech and pharma clients can save time and reduce costs while securing their drug development.
“Our aim is to transform how drugs are developed today by reducing the high attrition rate in clinical development, thus increasing the number of available therapeutic options for patients.”
The ISR platform is composed of complementary assays at these three levels:
- Organ – Genoskin can analyze in situ mast cell degranulation and release of pro-inflammatory cytokines upon subcutaneous injection of a molecule
- Cellular – functional human primary mast cells in culture are used to study the direct effect of a molecule on mast cell degranulation
- Molecular – complementary cell line assays are used to evaluate the capacity of a molecule to bind and activate MRGPRX2
Genoskin has filed intellectual property to protect the platform worldwide.