IMMUNOCLUSTER-2
Policy objective: PO1 - A more competitive and smarter Europe by promoting innovative and smart economic transformation and regional ICT connectivity
Specific objective: SO1 - Developing and enhancing research and innovation capacities and the uptake of advanced technologies
Typology: capitalization project
IIMMUNOCLUSTER-2 project addresses the strengthening of cross-border cooperation to improve the quality of life of the population.
- The general goal of the project is the initiation of a clinical trial for the treatment of triple negative breast cancer (TNBC) with a cell-based vaccine (aHyC) at the interregional level, to create the possibility of providing personalized advanced cancer therapies in an accessible and affordable way, to develop and improve innovation capabilities, and enabling the introduction of advanced technologies.
- Considering the existing situation, the project will promote innovation and improve technology transfer to SMEs, strengthen cooperation between innovative companies, research and healthcare institutions, and allow the capitalization of the results achieved in the previous project INTERREG ITASLO 2014-2020 Immuno-Cluster in a new integrated framework at regional level.
Management and coordination is going according to plan: we organized a kick-off meeting, which took place on September 7, 2023 online. At the meeting, we officially presented the content of the project to the members of all PPs, the planned activities in the project by work groups, information on the coordination of the project implementation and the administrative obligations of the partnership, as well as the time frames for achieving the project results. At the meeting, a steering committee was also appointed, consisting of representatives of all participating PPs, which will take care of the flow of information within PPs, between individual PPs and between PPs and VPs. The first periodic meeting took place live on 26 January 2024 at the Celica premises in Ljubljana. An interview was also published in the local media: https://sis-egiz.eu/2024/01/30/preboji-so-na-pragu/. As part of the activities for the preparation of aHyC immunohybridomas, the partners ZTM, VBC and Celica determined the protocol for the preparation of nDC in the NANT-XL bioreactor and the specifications of the leukapheresis preparation for the isolation of monocytes. We prepared and adapted a protocol for the preparation of aHyC immunohybridomas for TNRD and prepared a clinical study protocol for the treatment of TNBC with aHyC immunohybridomas.
On August 7, 2024, we held our second periodic meeting, focusing on key project milestones.
To ensure the regulatory adherence of our project, we proposed a collaborative workshop with national medicines agencies from Italy and Slovenia. This workshop aims to streamline the regulatory processes and foster cross-border cooperation.
We synchronized the preparation and quality standards for the leukapheresis product in collaboration with ZTM. Additionally, we initiated the implementation of NANT technology within a Good Manufacturing Practice (GMP) environment in partnership with VBC. ZTM successfully optimized the apheresis procedure to produce the most suitable product for dendritic cell (DC) preparation. This involved fine-tuning the separation parameters. To validate the process, we conducted an apheresis collection from a healthy donor. During this validation, we measured several critical parameters, including platelet activation levels and the percentage of immunosuppressive monocytes (CD14+DR lo/neg) in peripheral blood before and after the collection, as well as in the final apheresis product. These measurements could serve as potential quality markers for future apheresis procedures.
We are now preparing to apply for a clinical trial to both the JAZMP (Agency for Medicinal Products and Medical Devices of Slovenia) and the National Ethics Commission.