German-Australian iCAIR project

These days, even a “simple” infection can become a deadly threat. Bacteria keep developing new resistances to antibiotics, presenting the international medical community with a significant problem. There is a desperate need for new medications. The biggest hurdle in developing these new medications is getting them from the laboratory into clinical trials, bridging the gap from the discovery of new agents to their development by the pharmaceutical industry into potential medications. In the iCAIR^TM (Fraunhofer International Consortium for Anti-Infective Research) project, researchers from the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM have teamed up with colleagues from the Hannover Medical School (MHH) and Griffith University’s Institute for Glycomics (IfG) in Gold Coast, Australia, to close this gap and develop new anti-infective drugs.

As a close-knit research alliance, iCAIR^TM will be working on the development of anti-infective therapies that take new treatment options all the way from the identification of potentially beneficial substances to the preclinical proof of concept. iCAIR^TM will use selected lighthouse projects to establish and demonstrate its position as an expert preclinical development platform for new anti-infective drugs. One objective of these projects will be to target new treatments to combat infection-causing bacteria and fungi, including Pseudomonas aeruginosa, Neisseria meningitides and Aspergillus fumigatus, as well as the human parainfluenza and influenza viruses, and develop these treatments to the point of preclinical proof of concept (PoC).

The development platform established in the iCAIR^TM project is available to external partners in addition to its use in proprietary projects. This is geared towards contract research in the pharmaceutical industry as well as small and medium-sized enterprises and publicly funded projects. Thereby, iCAIR^TM enables them to develop their early-stage compounds to the stage of preclinical PoC ready to go into regulatory development for market approval or, depending on their business model, out-licensing to big pharmaceutical companies. Thus, by both ways iCAIR^TM contributes to filling the empty pipelines in anti-infective drug development to address the current global threat of antimicrobial resistance.

Our goals will be achieved by synergizing the partners' unique expertise:

1. Drug target identification (IfG, MHH)
2. Molecular characterization of targets (IfG, MHH)
3. Lead identification by stochastic and rational strategies (IfG)
4. Lead validation and preclinical efficacy and toxicology testing, proof of concept (Fraunhofer ITEM)

Fraunhofer ITEM has developed excellent systems for pharmacological and toxicological testing of novel drug candidates, ranging from in-vitro cell culture models via ex-vivo models based on tissues and organs from different species to in-vivo models. The models can be configured so as to mimic inhaled administration of active pharmaceutical ingredients to the lung as the target organ. Insights into the metabolization, toxicity, and efficacy of the drug and into the route of administration are thus enabled. Fraunhofer ITEM is pursuing an approach based on the 3 Rs and aimed at high predictivity of the developed test systems.

Below please find an overview of our infection models (further infection models available upon request):

Fraunhofer ITEM has safety level 2 labs and a GXP platform.  

For downstream development steps, the institute furthermore has access to clinical expertise, on inhaled antibiotics for COPD patients in particular.

iCAIR^TM meets the public demand for urgently needed novel anti-infectives by disrupting the current health paradigms in anti-infective R&D: developing drugs in a unique manner using knowledge-based, directed drug design.

iCAIR^TM covers the fully integrated drug development chain from ideas/concepts, target identification, hit-to-lead and non-clinical proof-of-concept to provide drug candidates in a one-stop-shop concept.

iCAIR^TM specifically caters to offer its fully integrated drug development platform towards academic groups, spin-offs, small- and medium-sized enterprises (SMEs), thereby bridging the gap between basic research and regulatory development in the currently transforming R&D environment.