Imaging of hypoxia (low oxygen level in tissues) is important in many disease states in oncology, cardiology, and neurology. Hypoxia is a common condition encountered within the tumor microenvironment that drives proliferation, angiogenesis, and resistance to therapy . Despite on-going efforts to identify hypoxia, until now there is no clinically approved imaging biomarker that is being used routinely, due to both low tumor uptake, and a low tumor to muscle (T/M) ratio. Our lab has shown that a 64Cu(II) radio isotope, coordinated by a small ligand and a small (6 amino acids) peptide (both ligand and peptide are non-toxic), named CuCysPhe, will provide both high sensitivity and improved selectivity to hypoxic conditions of tumors. Each part of the complex scaffold (chelating ligand and peptide) has a distinct role, such as tuning the appropriate reduction potential for Cu(II) intracellular reduction (ligand), and the selective intracellular delivery (peptide) via the main human copper transporter, termed hCtr1.
Three aims and activities were planned and completed:
Activity 1: in vivo validation of the designed radiotracer in mice, including toxicological tests, and evaluation of the efficacy. The outcome is a report on safety and imaging efficacy, which will be the core for the preclinical studies for advancing towards clinical studies and regulatory approval which will be pursued within the EIC transition project if funded.
Activity 2: consolidate the IP strategy and eliminate any IP-related barriers towards commercialization. The outcome is a report on IP strategy and advancing patent applications.
Activity 3: Market analysis as well as investigating the regulatory requirements. The outcome is market analysis report and regulatory assessment that will be the basis of EIC -transition application.
