Success Story: Ralph Weissleder
In his words
The i3 gave us sound advice on how to design and get our agent ready for IND and translation. The resources the i3 made available such as imaging in NHPs greatly helped us build confidence in our agent and allowed us to secure grants to fund the development of this class of agents.
Ralph developed a dextran nanoparticle that showed tremendous promise for imaging cardiovascular disease and for characterizing cancers. He wanted to evaluate this technology in human patients, with the aim of eventually getting it licensed for use in immunotherapy or cardiovascular medicine. Aspects of the chemistry of this nanoparticle presented development challenges.
How we helped
The i3 team provided a detailed analysis of the project and identified key studies and improvements needed for human translation of the probe. We provided consulting on the automated synthesis of the PET probe and its chemical characterization. i3 facilitated a NHP imaging study that provided pharmacokinetic behavior and allowed estimation of radiation dosimetry. We established a project plan for the IND submission, identifying key milestones and deliverables, and provided oversight as the project moved forward.
The new agent was successfully validated in NHP, which paved the way for external grant funding to support the exploratory IND submission.
Next big step
Exploratory IND submission and translation to human imaging.