October 2024
The 3rd Inno4Vac Annual Meeting and its’ Satellite Meetings took place at four locations over four days from 8-11 October 2024, in Heidelberg, Germany, and involved approximately 90 in-person participants attending to present, discuss, and drive the project forward. Project Subtopics held targeted and detailed scientific discussions at Satellite Meetings on 8 and 11, bookending the plenary sessions held on 9-10 October for the purpose of summarising progress, exploring ideas, and promoting the consortium’s young scientists.
Each subtopic was encouraged to dedicate a portion of their time to Ph.D. candidates and younger scientists, giving them visibility among their colleagues with the opportunity to display the results of their work. Alongside the presentations, a poster session was organised, affording all the option to showcase results obtained since the previous annual meeting. Members of the consortium voted for their favourites, and a poster prize was awarded to the winner. The winning poster was titled “Development of organoid models to study host-influenza virus interactions along the respiratory tract” by Martin Beukema. The plenary sessions also provided the possibility of convening the project Steering Committee and General Assembly, to cast votes on pressing matters – the most pertinent of which being the selection and confirmation of proposals solicited through the project’s open call, which ran from 24 June – 23 August 2024.
All four interlinked Subtopics of the project took part:
Subtopic 1 (VAXPRED), in which artificial intelligence in combination with big data analysis and computational modelling is being used to build an open-access and cloud-based platform for in silico vaccine efficacy assessment and development.
Subtopic 2 (CHIMICHURRI), which is developing new and improved controlled human infection models (CHIMs) against influenza, RSV and Clostridium difficile that will enable early vaccine efficacy evaluation.
Subtopic 3 (MERMAID), which contributes to the development of cell-based human in vitro 3D models that resemble the in vivo situation of an infection at the mucosa and more reliably predict immune protection. These models are being combined with the development of related functional immune assays for clinically relevant (surrogate) endpoints.
Subtopic 4 (VAXinS), which is developing a modular one-stop computational platform for in silico modelling of vaccine bio-manufacturing and stability testing.
In addition to the scientific-technical work, Inno4Vac partners are developing strategies and roadmaps for positioning the newly developed models in the regulatory framework and integrating them into pharmaceutical vaccine development. Over the four days of meetings, numerous action points were tackled and some of the most important outcomes are described below:
The annual meeting was a great and important opportunity for Subtopic 1 (VAXPRED) partners to meet in person and to productively discuss the results obtained during this year and explore ideas that will help achieve project objectives going forward. Discussions on the development of the in-silico platform to predict vaccine efficacy, benchmarking and integrating human B-cell receptor genomic and antibody proteomic profiling, the development and use of prediction methods for the rational identification of epitopes and Germinal Center (GC) modelling. ST1 Partners have made good progress in these areas this past year and it is hoped that the successful outcomes of ST1 will have a significant impact on the future of vaccine R&D.
Subtopic 2 (CHIMICHURRI) aims to implement CHIM models globally in vaccine development, including challenge strain selection, animal pre-clinical work, challenge agent manufacturing and clinical trial preparation, and regulatory acceptance. The meeting provided a productive space to hold in-depth scientific discussions to conclude on strain selection for Influenza, RSV and C. difficile and update on the progress made toward manufacturing challenge strains. In addition, partners touched upon the necessity of a sustainability plan to ensure access to produced strains after the end of the project. It facilitated alignment of work packages across Subtopics 2 and 3 on sample and data requirements for cross-activities. Further discussions were held on contingency plans and risk assessments, to identify activities that can be performed in parallel to de-risk and contract timelines. Further regulatory discussions are planned for early 2025 to facilitate ethical approval and regulatory acceptance for Inno4Vac CHIM trials.
Subtopic 3 (MERMAID) has made significant progress in developing cell-based human in vitro mucosa models that resemble the in vivo situation of an infection and more reliably predict immune protection than animal models. In vitro 3D Models presented at this annual meeting are capable of mimicking respiratory, gastro-intestinal, as well as uro-vaginal mucosae. The models allow assessment of infection and immunological responses to pathogens such as Clostridium difficile, RSV, norovirus, influenza virus, Chlamydia trachomatis, Neisseria gonorrhoeae, and HSV-2. Partners from academia and industry discussed the conducted research and results around air-liquid interface models, tissue-on-chip models, as well as organoids, with respect to overall suitability for vaccine research, and further aspects such as reproducibility, transferability, and added value of the models in the vaccine R&D chain. One important topic discussed was how precisely each model can be validated with respect to its biological relevance – this included interacting with regulators and understanding regulatory expectations, as well as with Subtopic 2 on availability of human samples (serum & peripheral blood mononuclear cells) from CHIM studies and further clinical or preclinical sources. Subtopic 3 has started to establish structured SOPs and to develop a regulatory roadmap which will be published soon.
Subtopic 4 (VAXinS) has developed several models of upstream and downstream processes of vaccine production. These include bioreactor models of computational fluid dynamics integrated with kinetic models of host cell metabolism, centrifugation models, as well as chromatography models. ST4 is rounded off by a comprehensive module on stability forecasting of vaccine products. One focus currently lies in assuring that the models are accepted by regulatory instances and can in practice be applied in an industry setting, where the demand is high for efficient scale-up, for which process modelling is a major accelerator. For this purpose, models are being validated by exchanging datasets between the partners and regulatory workshops are being held. The models developed as part of ST4 are currently being connected on a cloud-enabled open online platform with a user-friendly interface, and plant-wide control is being implemented. The models and results have been or will soon be published and the online platform will make these accessible to users in science and industry.
Images (from left to right): Subtopic 1 (VAXPRED) team at the Subtopic 1 Satellite Meeting; Subtopic 2 (CHIMICHURRI) team at the Subtopic 2 Satellite Meeting; Subtopic 3 (MERMAID) team at the Subtopic 3 Satellite Meeting; Subtopic 4 (VAXinS) team at the Subtopic 4 Satellite Meeting.
Consortium partners benefitted from the presence and recommendations of two members of the Scientific and Ethics Advisory Committee (SEAC) and are grateful for the feedback they provided during this meeting.
The third annual meeting was an important accelerator for Inno4Vac as a whole, giving the entire consortium the opportunity to come together to exchange ideas and promote further progress.
Members of the EVI Team, responsible for organising and running the meeting. From left to right: Mariele Boslet, Irina Meln, Romina Di Marzo, Reinhard Liebers, Sandra Hauenstein and Daniel Reem.
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Contact:
Dr. Irina Meln (Project and Innovation Manager at the European Vaccine Initiative)
Email: irina.meln@euvaccine.eu
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 101007799 (Inno4Vac). This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA (www.imi.europa.eu). This communication reflects the author´s view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained herein.
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