Demonstrating scalability from prototype to industrial manufacturing
To test the operative capacity of PHOENIX-OITB, five demo-cases representative of five different nano-pharmaceutical types, four different manufacturing methods and three different administration routes will be employed to demonstrate and verify the PHOENIX technologies in an industrially relevant environment.
Polymer-based diagnostic agent
Cenya Imaging BV produces imaging agents (BEACONS) that work across imaging modalities and that can be used in a range of applications, including quantitative, non-radioactive cell tracking in preclinical or clinical settings. The agents consist of polymer entrapping a perfluorocarbon and other cargo, to allow of multimodal imaging. Cenya Imaging has extensive published data on the imaging applications, as well as unusual internal structure and biocompatibility.
Polymeric particle conjugates loaded with small peptides
Topas Therapeutics is focused on developing nanoparticle-based drug products to address areas of major unmet need, including autoimmune diseases. Within PHOENIX, Topas Therapeutics is participating with innovative Topas Particle Conjugates (TPCs) to re-instate, through its administration by intravenous injection, the immunological tolerance in a selected autoimmune disorder, in which antigen-specific therapies are still lacking. Disease-relevant peptides, which are triggering T lymphocyte-mediated autoimmune responses in this disease, are coupled to these TPCs and their efficacy will be assessed in preclinical proof of concept and toxicology studies using appropriate animal models, to disprove any toxic effects. The production of these particle-peptide conjugates will be scaled up according to GMP requirements to be ready for clinical application.
Oral formulation of nanocrystals
MyBiotech developed a fast-acting oral formulation of NSAID nanocrystals without food effect. Free base formulations of NSAIDs have low COGs but slow onset of action and are associated with GI-tract adverse events. Previous attempts from multiple parties to develop faster acting formulations resulted in increased COGs and couldn’t eliminate performance difference between fed and fasted state to date. A fast-acting oral formulation of Ibuprofen nanocrystals without food effect produced with a process overcoming manufacturing challenges of scalability, stability and batch-to-batch variations for nanocrystals exceeds the expectations. Clinical test material of this oral nanoformulation will be produced under GMP conditions ready for clinical trials.
Nanoliposomes loaded with an enzyme for intravenous administration
Nanomol Technologies, ICMAB-CSIC, and Leanbio join efforts to advance the development of peptide targeted nanoliposomes for Fabry rare disease treatment. The entrapment of α-galactosidase (GLA) enzyme in these patented nanocarriers aims to improve the current enzymatic replacement therapy of Fabry disease, consisting in the intravenous administration of exogenous GLA to patients. These targeted nanovesicles are produced by DELOS technology, a robust & green nanoformulation platform owned by Nanomol Technologies. This novel nanomedicine, designated as an Orphan Drug by the EMA, has been developed under Smart4Fabry EU-project. Within PHOENIX, it will be scaled-up and manufactured under GMP to enable its clinical testing.
Antimicrobial nanovesicles for topical administration
Nanomol Technologies and ICMAB-CSIC are co-developing a potential nanomedicine for the topical treatment of microbial skin infections. This novel formulation, based on non-liposomal nanovesicles, exhibit inbuilt antimicrobial activity preventing infections, and has demonstrated to be effective against biofilms. The nanovesicles are prepared by DELOS technology, a robust & green nanoformulation platform owned by Nanomol Technologies. These nanovesicles show an extraordinary colloidal stability, which favours the production of high-quality pharmaceutical formulations. Within PHOENIX, the nanopharmaceutical will be scaled-up and manufactured under GMP.