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

Project description

Noninvasive in vivo cell imaging technology

Development of cell therapies such as CAR-T and stem cells, would greatly benefit from the ability to non-invasively track and quantify cells infused into patients. The goal of this EU-funded project is to develop imaging beads for contrast enhancement (BEACONs) to label cell therapies ex vivo and measure biodistribution in vivo using non-invasive imaging technologies for use both preclinically and clinically. Recent advances in the field of cell therapies such as CAR-T and stem cell therapies coupled with the need for biodistribution data and greater safety during clinical trials create attractive markets for such cell tracking technology. Cenya is working with regulatory advisers to define a development plan and obtain broad regulatory approval of BEACONs for use with any type of cell therapy in humans.

Objective

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.

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Keywords

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Programme(s)

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Topic(s)

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Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

ERC-POC - Proof of Concept Grant

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Call for proposal

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(opens in new window) ERC-2019-PoC

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Host institution

CENYA IMAGING B.V.
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 150 000,00
Address
TWEEDE KOSTVERLORENKADE 11H
1052RK Amsterdam
Netherlands

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
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Total cost

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No data

Beneficiaries (1)

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