Photoacoustic imaging and artificial intelligence-based theranostic approach for cancer

Project Information

PHIRE

Grant agreement ID: 101113193

DOI

10.3030/101113193

EC signature date 19 April 2023

Start date 1 September 2023

End date 31 August 2026

Funded under

• The European Innovation Council (EIC)

Total cost

€ 2 084 871,88

EU contribution

€ 2 084 871,25

Coordinated by

OSPEDALE SAN RAFFAELE SRL
Italy

Periodic Reporting for period 1 - PHIRE (Photoacoustic imaging and artificial intelligence-based theranostic approach for cancer)

Reporting period: 2023-09-01 to 2024-08-31

Summary of the context and overall objectives of the project

Residual disease in bladder cancer after proper treatment is caused by technological and therapeutic limitations, as small tumors < 1 mm that are not resected during surgery because are not visible and in about 50% of the cases do not respond to therapies.
Supported by the EIC, PHIRE aims at bringing closer to market a novel high-resolution theranostic medical device effective in clinical applications and ready for use in human residual bladder cancer. Both male and female patients should benefit from this.
The device integrates an add-on module for deep organ imaging, which is combined with Artificial Intelligence-driven gold nanorod thermal therapy. Beyond its medical applications, PHIRE is poised to make significant impacts in the fields of imaging, nanotechnology, and software.
By offering a new and efficient solution for the eradication of bladder cancer residual disease, PHIRE stands out as a beacon of hope in the urology sector, providing crucial advancements in the healthcare of 600.000 patients per year. PHIRE will also have a socio-economic impact on healthcare systems, reducing the cost of bladder cancer management which is currently $ 10 billion/year.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The PHIRE consortium developed and completed all activities planned for the first 12 months of the project. The consortium has i) obtained the necessary permits for the use of the preclinical models, ii) developed the technology which will be validated in the coming months, iii) identified the business model, iv) started the dissemination and communication processes, and v) started activities for the industrial production of targeted gold nanorods (GNRs), by assessing the critical steps for the scale-up of the process and identification of regulatory requirements for their production in GMP.
The feasibility of the protocol of use for the theranostic application of PHIRE solution has been validated in mice and recently published by PNAS (DOI: 10.1073/pnas.2411583121). In the coming months, the technologies, software and targeted GNRs will be combined and adapted to the clinical scenario. PHIRE will move the Technology Readiness Level from 4 to 6.
PHIRE consortium has also delivered all expected Deliverables and Milestones as agreed in the Grant Agreement.
In parallel the consortium also started exploitation activities. One patent about the targeted gold nanorods (KER2) was filed on March 28 2024, and the business model for KER1 and KER2 was identified and agreed among the partners. The consortium also identified potential stakeholders to be engaged in the coming months to support the creation of a spin-off and the clinical trial that is foreseen after the end of PHIRE.
On top of all the above activities, efficient management of the project was implemented.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

PHIRE will pursue a long-lasting transformation impact on Technology, Society, Economy, Environment, and Educational ground, and important economic and societal benefits. PHIRE will have an impact on several market segments, such as photoacoustic imaging and ultrasound devices, nanoparticles, cystoscopes and endoscopes. Together these market segments have an important forecasted annual growth rate, which in 2020 is estimated at more than $ 30 billion.
PHIRE will also have an important socio-economic impact, by reducing the bladder cancer relapse in 75% of patients and reducing the economic burden of bladder cancer by $ 500 million/year.

Characterization Tables for the 2 Key Exploitable Results (KER) were prepared to assess their market features. The characterisation table is designed to collect information that will be then reviewed and further integrated during the project life. It includes the description of the problem the potential users of that solution have, the alternative solutions the early adopters have used so far, the unique value proposition, a description of the solution, the target market, and the go-to-market strategy.

Concerning the implementation of the technological device (KER1), we searched for the prior art by scouting available publications and patents. We identified that the combination of a technological device together with an artificial intelligence-based software that will assist clinicians in the detection and treatment of small bladder cancer lesions is novel and with high chance of protection.

Concerning the targeted GNRs (KER2):
-PHIRE partners UNIBO and OSR filed a patent in March 2024 about the targeted GNRs.
-The partner UNIBO has engaged the company Di Renzo Regulatory Affairs, a leading company in the field of regulatory consulting, to identify critical steps and amend the production of the nanoparticles according to regulatory needs.
-The PHIRE consortium has also taken advantage of the services provided by the EIC Tech to Market (T2M) Program; the workshops and the summary provided by the T2M were concluded in April 2024.
-Next, the PHIRE consortium has also taken advantage of another opportunity provided by the EIC T2M Venture Building Team; the PHIRE consortium and the T2M started the process of Freedom To Operate (FTO).

For the 2 KERs, we identified and agreed upon the business model.

All the above activities were relevant to assess the next needs and the related budget. The business plan of the 2 KERs is in constant evolution and the first draft will be available in February 2025. Nonetheless, the PHIRE consortium is already considering the creation of a spin-off, by which to raise the budget from the public (EIC Accelerator programme) and/or private stakeholders for the validation of the PHIRE solution in the clinical scenario.

To have a spin-off of interest for the stakeholders the spin-off has to include in his portfolio:
- Proof of concept of the foreground
- IPR and FTO
- Field of application
- Target market
- Key Opinion leaders on board

All the above points have already been delivered and evaluated. Furthermore, the team of the partner OSR includes the active presence of a key opinion leader in the field of urology, who is Dr. Marco Moschini; he is the author of over 400 scientific works published in indexed international journals (source: PubMed), a Reviewer of the main scientific journals in the urological and oncology field including the Lancet, Cancer, European Urology, The Journal of Urology, and British Journal of Urology international. He is the coordinator of the bladder cancer group of the Young Academic Urologists Working Parties of the EAU and is part of the international bladder cancer group (IBCG) and of the European guidelines on bladder cancer.

PHIRE solution for the identification and treatment of bladder cancer lesions <1 mm.