Nano-particulate ribopharmaceuticals for individualized tumor therapy / Phase I breast cancer trial

Nano-particulate ribopharmaceuticals for individualized tumor therapy / Phase I breast cancer trial

The aim of this joint project is to develop and clinically test new ribonucleic acid (RNA)-based therapies for treating cancer. These nano-medical drugs aim to modulate the patient’s immune system and to direct an immune response against tumor-specific recognition patterns (antigens). Ultimately these immunotherapies, in the form of individualized vaccines, are to be made available for clinical use in common cancers.

To this end, novel nano-medical formulations for targeted delivery of RNA, and technologies for their manufacture as clinical trial samples, are being developed. Using formulations that selectively target antigen presenting cells in the spleen, for the first time, the concept of a vaccine warehouse will be applied in a clinical trial. 

For this Phase I breast cancer clinical study, an antigen-pool with ideal tumor antigens is selected, and a “RNA-warehouse” is put together. This vaccine warehouse consists of collection of well-characterized lead compounds, several of which can be used simultaneously to treat a patient in as personalized a manner as possible. A particular patient receives only those leads from the pool with a high response rate and few side effects. For administration of the RNA vaccines to patients, nano-particulate formulations and technologies for manufacturing of the clinical batches will be developed.  Overall, with this project, the ‘clinical proof-of-concept’ (kPoC) for this novel technology for individualized tumor therapy will be provided.

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Personalization of vaccine therapy