ENDFLU's repository of (pandemic) seed vaccine candidates has been established based on the expression of influenza hemagglutinin (HA) by the Modified Vaccinia Ankara (MVA) vector. This is a technologically- and clinically advanced platform, with demonstrated broad intra-subtypic protective efficacy against influenza, elicited by humoral and cell-mediated immunity, both in animal models and in humans. The regulatory path towards their use upon the emergence of a new influenza pandemic is well advanced, in consultation with industry and regulatory authorities in EU (EMA) and India (CDSCO).
Pre-clinically well-advanced vaccine candidates have been optimized, by leveraging unique European and Indian scientific progress, strong expertise and know-how in the development of next-generation influenza vaccines. These include protein-based constructs based on a range of target influenza proteins and parts thereof as well as MVA constructs with conserved and/or cellular immunity targets. These ENDFLU vaccine candidates and other promising leads are further pre-clinically advanced throughout the duration of the project. Those reaching rigorous and critical milestones for their eventual production under Good Laboratory Practice (GLP) conditions have been selected to enter GMP production and Phase I clinical studies. One protein-based vaccine candidate and one MVA-delivered vaccine candidate have been selected based on preclinical stability, safety, immunogenicity and protective efficacy data as well as criteria facilitating their rapid, economical, large-scale production and distribution worldwide, including in low- and middle-income countries (LMICs).
The protein-based vaccine candidate will be tested for safety and immunogenicity in a Phase I dose escalation clinical trial in India. The MVA-based construct will reach clinical readiness.
The ENDFLU approach takes advantage of promising influenza and unique vaccine development strategies of the Indian and European partners to ensure the synergistic development of a next generation rationally designed influenza vaccine candidate that will induce broad and potent humoral immunity against seasonal influenza A and B viruses through the protein-based component and robust and cross-reactive cell-mediated immunity through the MVA-based component.
A detailed exploitation plan, including a clinical development roadmap, has been prepared for continued clinical development of ENDFLU’s broadly protective influenza vaccine beyond the ENDFLU Phase I clinical trial.
