October 2023
To advance the ambitious programme of Inno4Vac – which aims to harness the latest advances in immunology, disease modelling, and modelling for tackling persistent scientific bottlenecks in vaccine development and for de-risking and accelerating this process – an Annual Meeting was held for all involved Partners. The 2nd Inno4Vac Annual Meeting took place on 4 and 5 October 2023, in Lyon, France, and involved approximately 120 participants to present, discuss, and drive the project forward.
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) is developing new and improved controlled human infection models (CHIM) against influenza, RSV and Clostridium difficile that will enable early vaccine efficacy evaluation.
Subtopic 3 (MERMAID) 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) 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. During the meeting, 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 forwards. Discussions on the development of the in-silico platform to predict vaccine efficacy, the generation of reliable and relevant biological data for development of improved in silico tools for predicting immune formation, s, the quantification of the heterogeneous baseline of the human adaptive immune system 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, necessitating alignment for clinical trial preparedness and regulatory acceptance. The annual meeting provided a productive space to hold in-depth scientific discussions on the characterisation of the challenge agents for respiratory viruses (Influenza, RSV) and C. difficile for manufacturing and clinical study design (population, endpoints, sampling, etc). In addition, it facilitated alignment of work packages across Subtopic 2 and collaboration with Subtopics 1 and 3 on sample and data requirements for cross-activities. Further discussions were held contingency plans and risk assessments, to identify activities that can be performed in parallel to de-risk and contract timelines. Clinical trial protocol discussions with regulatory experts are planned for early 2024 to facilitate ethical approval and regulatory acceptance for Inno4Vac CHIM trials.
Subtopic 3 (MERMAID) has recently completed phase one of the project – the “development phase”, and this meeting allowed developers and industry partners to review data supporting the success criteria of stage gate one; as well as discuss next steps for the models which have been selected to pass into stage two – the “exploratory phase”. In its efforts in creating in vitro models to reliably predict immune protection and develop them to de-risk vaccine development and enter the regulatory space, discussions were held on progress made over the last year on how best to transition from a research discovery process to a tool to support preclinical/clinical studies, and how to prepare models for successful validation. Key topics to cover at next year’s final regulatory meeting were identified, and the newly created SOP harmonization document was introduced. In addition, important discussions and alignment occurred between groups in Subtopic 2 and Subtopic 3 working on RSV and influenza, to best leverage expertise within the consortium.
Subtopic 4 (VAXinS) has achieved significant deliverables and milestones in developing a comprehensive in silico model that links critical phases in the vaccine production process, encompassing both upstream and downstream procedures. Progress was reported in several areas, including combining mechanical bioreactor models (i.e. computational fluid dynamics and compartment models) with kinetic models of protein production in e. coli. Additionally, progress was presented on digital replicas of purification processes such as centrifugation and chromatography. Of particular importance, these advancements are being linked and integrated into a single online platform and plant-wide control is currently being implemented for these models. As vaccine accessibility depends on vaccine stability, the vaccine stability forecasting models are a core aspect of this project and have made a significant leap forward. During the meeting, an array of data was presented, including experimental data, real-world data, and mathematical models. Next steps were discussed and include publishing the codes and models as well as demonstrating their usability by publishing use cases and scientific papers. Notably, VAXinS has collaborated with regulatory experts at every point, ensuring that the models are validated appropriately and are dependable, cost-effective, flexible, and safe.
The meeting included two keynote lectures, by Charlotte Vernhes (Sanofi) on ‘European Public Private Health Partnerships: a shared value innovation accelerator’, and Wayne C. Koff (Human Immunome Project) on ‘AI and the Future of Vaccine Development’. Five members of the Scientific and Ethics Advisory Committee (SEAC) were in attendance, and the consortium is particularly grateful for the feedback they provided by them during this meeting.
Participants of the Inno4Vac 2nd Annual Meeting (4-5 October 2023, Palais de la Bourse de Lyon, France).
The second Inno4Vac annual meeting was an important accelerator for Inno4Vac as a whole, by bringing together the entire consortium and allowing most efficient exchange and progress – in a historic venue, the Palais de la Bourse de Lyon, France.
Members of the Inno4Vac Management Team and SEAC at the 2nd Annual Meeting. From left to right: Marie-Jose Quentin-Millet (SEAC), Sandra Morel (GSK) (EFPIA Lead), Wayne Koff (SEAC), Donata Medaglini (UNISI/SVA) (Inno4Vac Scientific Coordinator), Giuseppe Del Giudice (SEAC), Geert Leroux-Roels (SEAC), Maxime Mahe (SEAC), Ole Olesen (EVI) (Inno4Vac Coordinator).
From left clockwise: Sub-topic 3 (MERMAID) parallel session, Sub-topic 2 (CHIMICHURRI) parallel session, Sub-topic 4 (VAXinS) parallel session.
Sub-topic members took advantage of the opportunity to meeting in person in Lyon to hold satellite meetings organised by EVI and Sanofi. Read more here:
ST1 VAXPRED: link
ST2 CHIMICHURI: link
ST4 VAxins: link
Generic posts of the meeting can also be seen on Twitter (X) and LinkedIn posts:
LinkedIn > link
Twitter (X)> link
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.