Press releases

Initiation of Phase Ia/Ib1 with the first human administration of the intranasal form of OM-85, a bacterial lysate and immune system modulator, already approved in oral form for the prevention of recurrent respiratory tract infections. Trial aims to deepen and understanding of OM-85-Intranasal (IN) and explore its potential impact on asthma management when administered as a nasal spray. (Geneva) OM Pharma, a global Geneva-based biotech and leader in bacterial lysate products, in collaboration with Fraunhofer Institute for Toxicology and Experimental Medicine ITEM announce the dosing of the first participant in a Phase Ia/Ib clinical trial evaluating the safety and tolerability of OM-85-Intranasal (IN) in 27 healthy volunteers during Phase Ia and 14 patients with mild asthma during Phase Ib.

The BIOSYNTH project is funded by the Fraunhofer-Gesellschaft and aims to develop a new microchip platform that enables efficient and digitally controllable cell-free biosynthesis. The Fraunhofer Institute for Photonic Microsystems IPMS leads the consortium and collaborates with the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM and the Fraunhofer Institute for Cell Therapy and Immunology, part of Bioanalytics and Bioprocesses IZI-BB, on technologies that can be used in the future for mass data storage with very high storage density or in pollutant screening in human toxicology.

Every year, around half a million people in Germany are diagnosed with cancer. Despite the existence of effective treatment options for many types of cancer, many questions about the development of the disease remain unanswered. Why does a tumor develop? What factors promote the growth of cancer cells? Why do metastases spread to other organs over time? The animal models mainly in use to date only represent the actual processes in the human body to a limited extent. The Fraunhofer Institute for Material and Beam Technology IWS in Dresden has developed special microsystems in collaboration with the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM in Hanover and the University of Regensburg. They are now using them to examine tissue sections of tumors under realistic conditions.

With the aim of developing a new technology for brain regeneration, the EU project REGENERAR kicks off on March 22, 2024. Fraunhofer ITEM is one of seven research partners, led by the University of Coimbra, seeking to create better therapies for patients with neurodegenerative diseases or stroke using this technology.

A research team from the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM and the Hannover Medical School (MHH) have made significant progress in developing a new antiviral therapy. The drug, which is inhaled, uses RNAi to target and deactivate parainfluenza viruses before they multiply.

The European Chemicals Agency (ECHA) has contracted a consortium led by the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, coordinated together with Michabo Health Science and BASF Metabolome Solutions, to conduct scientific studies on the reliability and relevance of new approach methodologies (NAMs) as alternatives to animal studies and to promote the use of such methods in the future. The aim of the contract is to get additional NAMs accepted by regulatory authorities, focusing on OMICS technologies and toxicokinetics, and therewith further reduce the number of animal studies conducted as part of safety assessments for chemical substances. The contract will run for six years for a total value of 4.2 million euros in ECHA funding. Other partners include the department for experimental toxicology and ecology at BASF, the University of Birmingham, and the biotech companies BioClavis, and Novogene Europe.

After three years in his post, Professor Thomas Thum has left the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM and has stepped down from his joint institute management role at his own request. Instead, he will now be refocusing his attention on his positions as director of the Institute of Molecular and Translational Therapeutic Strategies at the Hannover Medical School (MHH) and as managing director of MHH spin-off Cardior Pharmaceuticals GmbH.

There are still no effective drugs for most viral diseases. Antiviral therapies are therefore urgently and quickly needed. However, the development of therapeutics can take decades. In the iGUARD (integrated Guided Ultrafast Antiviral RNAi Drug Development) project, a team of researchers from Fraunhofer ITEM and Hannover Medical School (MHH) has set itself the goal of developing customized therapies as quickly as possible. The iGUARD project has already been funded twice by the Federal Agency for Disruptive Innovation as part of the SPRIND Challenge “Broad-Spectrum Antivirals” and, as a finalist in the third and final round of the innovation competition, will now receive a follow-up funding up to 2.5 million euros for the further development of new antiviral agents.

Fraunhofer ITEM is actively supporting the regulatory development of environmental risk assessments for drugs. The aim of an ERA is to ensure that the drug manufacturer understands the possible environmental risks and takes appropriate steps to minimize these risks.