How can we help?

Development of a vaccine, monoclonal antibody or small molecule is complex and multifaceted
With the philosophy of ‘beginning with the end in mind’, VaxxCellence offers support across all stages of the development process
From bench to bedside: translating the science into a concept that can be taken from preclinical to clinical stages, always keeping the final product in mind

VaxxCellence can support this by offering the following services:

Design the roadmap from Discovery to Target Product Profile
Discovery ⇒ Preclinical ⇒ Mode of Action ⇒ Clinical Development
Developing the Biomarker strategy
Translational Science & Reverse Translation
Scientific writing

Supported by

16 years of R&D experience in industry
14 years of academic immunology background
>100 peer-reviewed publications
Cum laude PhD in coronavirus molecular biology
MSc in Health Economics, Policy & Management (LSE, London)

Beginning with the end in mind

Designing the early preclinical and clinical phases with a view on who will be treated and why – asking the right questions

Who is going to be treated or vaccinated and why?
This defines the Target Product Profile
Which clinical studies and what data are needed to support the product claims?
This guides the Clinical development plan
Where to start?
Phase 1 design
What do we need to measure and how to do this?
Endpoint selection, assay selection & immunology
How does it work?
Experimental designs to clarify the mode of action
And then, what’s next?
Considering post-licensure commitments for safety and effectiveness

Connecting the science with the product

Starting at the bench and driven by the scientific concepts, it is critical to define both the research and the development objectives in a forward-looking way. This means that early evidence generation should support and inform the entire series of next steps in the CDP.

VaxxCellence supports this process for a range of potential products, such as:

Vaccine adjuvants, antigens and formulation
Monoclonal antibodies
Small molecules

Readings:

O’Hagan et al, 2021. "World in motion" - emulsion adjuvants rising to meet the pandemic challenges NPJ Vaccines 6:158
Arunachalam et al, 2021. Adjuvanting a subunit COVID-19 vaccine to induce protective immunity Nature 594:253

Discovery

Translating the science into a concept for a product

A scientific concept is connected to a medical need and the type of product to address that need. ‘First time in human’ (FTIH) is a key milestone that is the next step after the Discovery phase.

Support in antigen discovery, vaccine design and formulation
Preclinical design
Requirements for entering clinical phase (tox, preclinical, cmc)

Readings:

Zuiani A et al, 2024. A multivalent mRNA monkeypox virus vaccine (BNT166) protects mice and macaques from orthopoxvirus disease, Cell 187 (6): E1363
Arunachalam P et el, 2021. Adjuvanting a subunit COVID-19 vaccine to induce protective immunity, Nature 594:253

Mode of action

How does it work?

Understanding the mode of action is important for multiple reasons. First, it guides the clinical readout strategy and any immunological endpoints. Second, it provides the scientific framework required to interpret clinical data, ranging from immunological results to reactogenicity, safety and efficacy data. Third, it opens the door to iterative product improvements. As an example, the mode of action of an mRNA/LNP vaccine is illustrated. VaxxCellence can support key steps such as:

Developing mode of action models
Supporting data from preclinical to in vitro and early clinical

Readings:

Coccia et al, 2017. Cellular and molecular synergy in AS01-adjuvanted vaccines results in an early IFNγ response promoting vaccine immunogenicity, NPJ Vaccines 2
Buckley et al, 2019. Application of Modeling Approaches to Explore Vaccine Adjuvant Mode-of-Action, Front Immunol 10
Bechtold V et al, 2024. Functional and epigenetic changes in monocytes from adults immunized with an AS01-adjuvanted vaccine, Transl Med 16(758)