SenzaGen and AstraZeneca initiate technology development collaboration

SenzaGen has signed a collaboration agreement with the global biopharmaceutical  company AstraZeneca. The collaboration focuses on  testing and development of SenzaGen’s sensitization test GARDair, in order to distinguish between allergens and irritants in the respiratory tract. The goal is the validation of in vitro toxicological tests that could be applied to the discovery of new treatments for respiratory diseases without respiratory tract irritancy as a side effect.

 

The collaboration means that SenzaGen will use its leading technology platform GARD, with the help of AstraZeneca’s well-documented substance libraries, to develop a new genomic signature to distinguish allergens from irritants in the respiratory tract, something which is not possible today with in vitro methods. GARD examines and finds allergens in chemicals and medicines through a unique technology in accordance with the international 3Rs principle, Reduce, Replace and Refine, as an alternative to animal testing.

“During our research and drug discovery activities, it is important to be able to identify and mitigate potential toxicological issues as early as possible, to ensure our novel candidate drugs have the right safety profile for patients. This requires in vitro toxicological methods that are properly validated for their predictivity of clinical toxicity and that are compatible with integration into the drug discovery process. By combining SenzaGen’s technological expertise and our experience with inhaled compounds, we aim to develop a novel method to investigate whether novel drug-like molecules induce similar genomic signatures as known respiratory irritants. That could ultimately be applied to steer away from a potential irritancy hazard and enable the discovery of safer drugs for patients’” says Jorrit Hornberg, Director of Discovery Safety at AstraZeneca Gothenburg.

With this new agreement SenzaGen is initiating yet another important development collaboration with the pharmaceutical industry. SenzaGen’s focus is on introducing its tests into the pharmaceutical industry and on striving to demonstrate that there are safer and more accurate tests than those that use animals.

“This collaboration with AstraZeneca is a milestone for SenzaGen. It shows that leading pharmaceutical companies see the potential of next-generation testing and that this testing has considerable industrial value. Furthermore, the collaboration will provide SenzaGen with valuable knowledge and will help to refine and develop our GARD test for further commercial opportunities,”says Anki Malmborg Hager, CEO of SenzaGen.

The research project will run for 12 to 18 months and is in collaboration with AstraZeneca Gothenburg, contributing to the EU Horizon 2020 project granted to SenzaGen for the development of in vitro respiratory sensitization test.

 

For more information:

Anki Malmborg Hager, VD, SenzaGen AB
Email: amh@senzagen.com
Tel: +46 768 284822

 

 

About GARD
GARD is a group of tests for assessing chemical skin sensitizers. The tests make use of genetic biomarkers for more than 200 genes which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity. The tests have 90% reliability. This compares with the current predominant test method, experiments on mice, which has a reliability rating of 72%. SenzaGen’s tests are also capable of measuring the potency of a substance’s allergenic properties. Consequently GARD tests provide a much more comprehensive basis for determining whether a substance should be classified as an allergen than current testing methods.

About SenzaGen
SenzaGen makes it possible to replace animal experiments with in vitro genetic testing to determine the allergenicity of the chemicals we come into contact with in our daily lives, such as for example in cosmetics, pharmaceuticals, food products and dyes. The company’s patented tests are the most reliable on the market and provide more information than traditional evaluation methods. We ourselves sell the tests in Sweden and the USA, and we sell through partners in several other countries. Over the next few years the company will expand geographically, make alliances with more distribution partners and launch further unique tests. SenzaGen has its headquarters in Lund in Sweden and a subsidiary in San Francisco, USA. For more information visit www.senzagen.com.

 About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

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SenzaGen AB, a diagnostic spin-off company from Lund University, reports the launch of a new product for respiratory sensitization testing

SenzaGen AB is a diagnostic company working to replace animal testing for sensitization predictions.

“Sensitization through the lung is a growing issue and methods to predict if a chemical has a sensitization effect are limited”, says Anki Malmborg Hager, CEO in SenzaGen. Based on extensive research about the responses of the immune system in allergic reactions, SenzaGen has now launched a test that predicts the respiratory sensitization ability of chemicals based on the GARD methodology.

An international scientific article about the underlying research has been published in PLOS ONE, under the title “Prediction of Chemical Respiratory Sensitizers Using GARD, a Novel In vitro Assay Based on a Genomic Biomarker Signature”. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0118808

SenzaGen´s first product, a skin sensitization test of chemicals, is already on the market.

Prediction of chemical respiratory sensitizers using GARD, a novel in vitro assay based on a genomic biomarker signature.

PLoS One. 2015 Mar 11;10(3):e0118808. doi: 10.1371/journal.pone.0118808. eCollection 2015.

Forreryd A., Johansson H., Albrekt AS, Borrebaeck CA, Lindstedt M.

Abstract

BACKGROUND:

Repeated exposure to certain low molecular weight (LMW) chemical compounds may result in development of allergic reactions in the skin or in the respiratory tract. In most cases, a certain LMW compound selectively sensitize the skin, giving rise to allergic contact dermatitis (ACD), or the respiratory tract, giving rise to occupational asthma (OA). To limit occurrence of allergic diseases, efforts are currently being made to develop predictive assays that accurately identify chemicals capable of inducing such reactions. However, while a few promising methods for prediction of skin sensitization have been described, to date no validated method, in vitro or in vivo, exists that is able to accurately classify chemicals as respiratory sensitizers.

RESULTS:

Recently, we presented the in vitro based Genomic Allergen Rapid Detection (GARD) assay as a novel testing strategy for classification of skin sensitizing chemicals based on measurement of a genomic biomarker signature. We have expanded the applicability domain of the GARD assay to classify also respiratory sensitizers by identifying a separate biomarker signature containing 389 differentially regulated genes for respiratory sensitizers in comparison to non-respiratory sensitizers. By using an independent data set in combination with supervised machine learning, we validated the assay, showing that the identified genomic biomarker is able to accurately classify respiratory sensitizers.

CONCLUSIONS:

We have identified a genomic biomarker signature for classification of respiratory sensitizers. Combining this newly identified biomarker signature with our previously identified biomarker signature for classification of skin sensitizers, we have developed a novel in vitro testing strategy with a potent ability to predict both skin and respiratory sensitization in the same sample.

Link to article on line

GARD – Genomic Allergen Rapid Detection. A Testing Strategy for Assessment of Chemical Sensitizers

Doctoral thesis
defense date 2013-06-05 09:00     ISBN978-91-7473-519-2

Johansson, Henrik LU

Abstract (Swedish)

Popular Abstract in Swedish

Vi lever i en tid och i ett samhälle där kemikalier har blivit en naturlig del av vår industrialiserade vardag. Till stor del ligger kemikalieindustrin bakom flera av de stora tekniska framsteg som gör att västvärlden har den levnadsstandard den idag har. Tyvärr har den stora spridningen av icke naturligt förekommande kemikalier ibland också negativa effekter både på miljö och hälsa. Ett stort antal tungmetaller har visat sig ackumuleras i naturliga näringskedjor, för att slutligen lagras i mänsklig vävnad, med ännu ej helt fastställda konsekvenser. Flera kemiska bekämpningsmedel slår hårt mot naturliga ekosystem, men har också visat sig påverka människors hormonella balans, vilket bland annat… (More)

Abstract

The modern world is increasingly dependent of the use of chemicals. The chemical industries have greatly contributed to the high standard of living in industrialised societies, and chemical compounds surround us in everyday life. Unfortunately, a vast number of chemicals cause adverse effects on the environment and human health. One such concern is chemical hypersensitivity, which is a state caused by the human immune system. Upon exposure of certain chemical substances, the body will in some instances mount immunologic responses, giving rise to clinical symptoms such as irritation and damage on skin and impaired function of the respiratory tract.

In order to limit the usage of chemical compounds that induce…more