Feasibility phase

In recent years, new forms of therapy such as cell and gene therapies have been approved for the treatment of patients for the first time. In contrast to conventional medicines, these advanced therapeutics are “living medicines” that divide in the body and have to migrate into tissue to develop their effect there. It is useful to pinpointnthe exact location and amount of these therapeutic agents in the body.

Visualizing Cell and Gene Therapies in Real Time

The RaidoGene-2 project team has developed a labelling process for this purpose. The method can visualise the new therapeutic agents with particular precision in positron emission tomography (PET). The labelling method developed is the subject of an international patent application and differs from previous methods in that it can detect particularly low cell numbers (sensitivity). It also does not suffer from non-specific signals, which means that even the smallest cell accumulations can be reliably detected (specificity). The innovative labelling process can be used throughout the entire life cycle of the drug, from preclinical drug development to application in the patient.

Conceptual phase

Many novel forms of therapy, such as cell and gene therapies, have recently been approved for the treatment of patients for the first time. In contrast to classical drugs these advanced new therapeutics are ‘living medicines’ that are designed to divide and migrate in the body in order to exert their effect. In order to be able to precisely localise them in the body and to quantify and determine their amount, a labelling method that makes the new therapeutics visible with particular precision in positron emission tomography (PET) for the first time was developed. This is because the classic approach, in which, for example, tumour markers are visualised in PET with a contrast agent, is not applicable to these new forms of therapy. The developed labelling method will be used in therapy monitoring of patients and in the development of new cell and gene therapies.

The aim of the project is to optimise the labelling process, commercialise it for pharmaceutical research and approve it for clinical application. To this end a spin-off and cooperation with a contract manufacturer in the pharmaceutical industry are planned. In addition to the optimisation of the product an IP strategy, a market analysis as well as an implementation plan for the clinical translation of the process and a risk analysis for the intended spin-off will be developed in the exploratory phase.

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