Periodic Reporting for period 1 - Accelerate.EU (Elevating the Future of Cancer care with Alpha Theranostics)
Período documentado: 2024-10-01 hasta 2025-09-30
ACCELERATE.EU project factsheet for the IHI website
The accelerate.EU project aims to improve the future of cancer care with Alpha Theranostics. In theranostics, a diagnostic test and therapy that both bind to the same target are paired up. For example, a molecule targeting a specific protein on a cancer cell could carry a radioactive isotope that shows up on a scan to diagnose the disease, and then another radioactive isotope designed to destroy cancer cells.
The aim of ACCELERATE.EU is to transform cancer care by pioneering the development of novel radiotheranostic pairs in which the therapy part features the radioactive isotope astatine-211 (211At). What sets 211At apart from other similar treatments is the fact that it emits alpha particles, and so could prove effective at treating cancers that are resistant to beta and gamma particles as well as chemotherapy.
The project will focus its efforts on three highly aggressive cancers: pancreatic, breast and brain cancer, all of which are characterised by rapid progression, resistance to conventional therapies, and high mortality rates. For each cancer, the project will use a molecule that targets a protein found on the tumour cells to carry a diagnostic marker that shows up on PET (positron emission tomography) or SPECT (single photon emission computed tomography) scans. The same molecule will then be used to carry the 211At to the tumour.
To make progress in this highly innovative area, the project plans to adopt a co-clinical approach, in which clinical studies run in parallel with pre-clinical studies using tumour samples taken from the patient. The team hopes that this approach will improve our ability to identify the patients most likely to benefit from 211At therapy.
In parallel, the project aims to facilitate 211At production and access by developing a new generation cyclotron. A cyclotron is a particle accelerator and so can be used to generate isotopes like 211At. The ACCELERATE.EU cyclotron would be more compact and easy to use, meaning trained medical staff would be able to use it in hospitals to generate 211At as and when it is needed – an important issue given its short half-life (about 7h).
In the long term, ACCELERATE.EU hopes its efforts will result in establishing a stable cross-EU for 211At supply chain enabling a wider availability/access of theranostic pairs using 211At and a greater ability to identify the patients who are most likely to benefit from them.
The accelerate.EU project aims to improve the future of cancer care with Alpha Theranostics. In theranostics, a diagnostic test and therapy that both bind to the same target are paired up. For example, a molecule targeting a specific protein on a cancer cell could carry a radioactive isotope that shows up on a scan to diagnose the disease, and then another radioactive isotope designed to destroy cancer cells.
The aim of ACCELERATE.EU is to transform cancer care by pioneering the development of novel radiotheranostic pairs in which the therapy part features the radioactive isotope astatine-211 (211At). What sets 211At apart from other similar treatments is the fact that it emits alpha particles, and so could prove effective at treating cancers that are resistant to beta and gamma particles as well as chemotherapy.
The project will focus its efforts on three highly aggressive cancers: pancreatic, breast and brain cancer, all of which are characterised by rapid progression, resistance to conventional therapies, and high mortality rates. For each cancer, the project will use a molecule that targets a protein found on the tumour cells to carry a diagnostic marker that shows up on PET (positron emission tomography) or SPECT (single photon emission computed tomography) scans. The same molecule will then be used to carry the 211At to the tumour.
To make progress in this highly innovative area, the project plans to adopt a co-clinical approach, in which clinical studies run in parallel with pre-clinical studies using tumour samples taken from the patient. The team hopes that this approach will improve our ability to identify the patients most likely to benefit from 211At therapy.
In parallel, the project aims to facilitate 211At production and access by developing a new generation cyclotron. A cyclotron is a particle accelerator and so can be used to generate isotopes like 211At. The ACCELERATE.EU cyclotron would be more compact and easy to use, meaning trained medical staff would be able to use it in hospitals to generate 211At as and when it is needed – an important issue given its short half-life (about 7h).
In the long term, ACCELERATE.EU hopes its efforts will result in establishing a stable cross-EU for 211At supply chain enabling a wider availability/access of theranostic pairs using 211At and a greater ability to identify the patients who are most likely to benefit from them.
For this 1st reporting period (1y):
-Progress has been made in developing theranostic pairs for TNBC and GBM. DualFAPi and Substance P precursors have been synthesized and radiolabeled with F-18 and I-123/131, enabling early biodistribution studies and pharmacokinetic optimization. Preclinical models for TNBC have been established and validated, and ethical approvals for co-clinical studies have been obtained. While At-211 capabilities are still being scaled up, surrogate isotopes (I-131) are used to maintain momentum. Preparations for pilot clinical studies are underway, with protocol updates and feasibility assessments completed.
-The consortium has successfully mapped current and emerging At-211 production capacities and initiated deliveries from Rigshospitalet and Arronax. FZJ obtained a permanent operating license for its Cyclone 30XP and achieved proof-of-concept production runs, while Arronax commissioned an internal target system and automated extraction module. IBA validated the concept for a dedicated At-211 cyclotron and entered the design phase. Logistics frameworks for isotope transport and GMP compliance have been defined, and infrastructure upgrades across sites are progressing to ensure scalability and reliability of supply.
-Foundational communication and training activities have been implemented. A project website, social media presence, and dedicated Oncidium Foundation page were launched. A training material inventory and educational plan were completed (Deliverable 7.4) and collaborations with PRISMAP and IAEA have been initiated to develop MOOC modules and an IAEA TECDOC on At-211 production and QC. Dissemination efforts included presentations at major congresses (EANM, ISRS, ICPO) and publications in Radiotheranostics Today, ensuring visibility and stakeholder engagement. These actions lay the groundwork for structured educational programs in 2026.
-Progress has been made in developing theranostic pairs for TNBC and GBM. DualFAPi and Substance P precursors have been synthesized and radiolabeled with F-18 and I-123/131, enabling early biodistribution studies and pharmacokinetic optimization. Preclinical models for TNBC have been established and validated, and ethical approvals for co-clinical studies have been obtained. While At-211 capabilities are still being scaled up, surrogate isotopes (I-131) are used to maintain momentum. Preparations for pilot clinical studies are underway, with protocol updates and feasibility assessments completed.
-The consortium has successfully mapped current and emerging At-211 production capacities and initiated deliveries from Rigshospitalet and Arronax. FZJ obtained a permanent operating license for its Cyclone 30XP and achieved proof-of-concept production runs, while Arronax commissioned an internal target system and automated extraction module. IBA validated the concept for a dedicated At-211 cyclotron and entered the design phase. Logistics frameworks for isotope transport and GMP compliance have been defined, and infrastructure upgrades across sites are progressing to ensure scalability and reliability of supply.
-Foundational communication and training activities have been implemented. A project website, social media presence, and dedicated Oncidium Foundation page were launched. A training material inventory and educational plan were completed (Deliverable 7.4) and collaborations with PRISMAP and IAEA have been initiated to develop MOOC modules and an IAEA TECDOC on At-211 production and QC. Dissemination efforts included presentations at major congresses (EANM, ISRS, ICPO) and publications in Radiotheranostics Today, ensuring visibility and stakeholder engagement. These actions lay the groundwork for structured educational programs in 2026.