Ex vivo cell labelling for in vivo imaging applied to cell therapeutics

ended

While we do not possess magic, modern day medicine can sometimes approach the unbelievable - curing cancer or repopulating diseased heart tissue; all possible due to the advent of cell therapy. However, cell therapy has fallen far short of expectations. Its success requires the ability to monitor and optimise treatments in real time for each individual; necessitating a direct means of monitoring transferred cells. Noninvasive imaging techniques are essential to the success of modern therapeutics. Here, I will build on my work on developing multiscale GMP-ready imaging nanoparticle (NP) agents with the objective of out-licensing the technology to a new commercial venture, Cenya Imaging, to take this work from the bench to the bedside, and I have recruited an experienced CEO to drive this forward. Advisors have outlined a cheaper, faster and simpler path to regulatory approval for Cenya NPs: labelling cells ex vivo and tracking labelled cells after infusion into patients; since, with this approach, Cenya NPs are used to only track cells and not diagnose a disease, the regulatory hurdles are far lower. Recent developments in cell therapeutics have made tracking of cells a very attractive market; specifically (1) increasing investment in CAR-T cells, checkpoint inhibitors (which affect lymphocyte trafficking), and stem cell therapies (40% per annum growth in phase I trials); (2) regulatory push for increased safety and biodistribution data in trials; and (3) a lack of suitable clinical imaging agents. Market size is estimated at €300M; the FDA recently hired 50 new staff exclusively to deal with cell and gene therapies. We will exploit this new market, while also seeing this as the opportunity to play a significant role in the optimisation of cell therapies. We have surveyed nearly 100 users of cell therapy (preclinical, clinical; academics and industry) to decide on our approach, providing a good degree of validation for our choice of focus.