Preclinical proof of concept studies of a new generation of TLR7/8 agonist used in prevention against respiratory viruses and in immunotherapy against lung cancer.

A nanotechnology, named FB-631, is a new generation of toll like receptor (TLR) 7/8 agonist known to trigger innate immunity in the lungs. The manufacturing process of FB-631 has been already developed and validated. FB-631 previously showed an excellent safety profile in a phase I clinical trial in human. This new nanoparticle is stable at 4°C (<7 years) and at RT (<7days) and can be stockpiled without loss of activity or integrity. Several crucial steps of the development of this technology have already been completed making the search for novel applications very compelling. Other TLR7/8 agonists, like imiquimod (IMQ), are already on the market and used against warts (antiviral activity) and skin cancers. However, IMQ can only be used by the topical route because of its toxicity when administered otherwise. There is a medical need for a TLR7/8 agonist that can be injected or used by instillation/nebulization. FB-631 is safe and effective when used by instillation/nebulization and is well positioned to fulfill this medical need. Objective of the project: We intend to demonstrate the efficacy of FB-631 to prevent infection by respiratory viruses like the SARS-CoV-2. We also intend to demonstrate the potential of FB-631 in prevention of the implantation of lung cancers tumors and its potential in lung cancer immunotherapy. These proof-of-concept studies will generate convincing data that will support further development of this technology into the clinic. The team: The team combines an expert in the manufacturing of FB-631 (Leclerc) and in respiratory viruses, an expert in SARS-CoV-2 animal models (Baz) and an expert in lung cancer immunotherapy (Blanchet). The three researchers harbor the complementary expertise necessary to reveal all the potential of this technology.