Product Development Timeline

Milestones

Discovery Milestones

1. Rationale for candidate antigen
2. Viable process for candidate antigen production
3. Resources to facilitate development of investigational vaccine based on candidate antigen

Preclinical Milestones

4. Preclinical animal studies establishing potency parameters (e.g., ELISA, GIA, TBA)
5. cGMP production of drug substance (MCB, PCB, manufacture and testing): release of drug substance
6. Formulation optimization (including conjugation), cGMP production of drug product (manufacture and testing): release of drug product
7. GLP toxicity study of the drug product in an appropriate animal model: no signs of general toxicity

Clinical Milestones

8. U.S. FDA effective Investigational New Drug Application
9. Malaria-Naïve Phase I Trial
1. Blood-stage vaccine, malaria-naïve Phase I trial in adults: safe and immunogenic (ELISA)
2. Transmission-blocking vaccine, malaria-naïve Phase I trial in adults: safe and immunogenic (TBA)
3. Pre-erythrocytic vaccine, malaria-naïve Phase I/IIa trial in adults: safe, immunogenic, and protective
10. Malaria-Exposed Phase I Trial
1. Blood-stage vaccine, malaria-exposed Phase I trial in adults: safe
2. Blood-stage vaccine, malaria-exposed Phase I trial in children or infants: safe and immunogenic (ELISA)
11. Blood-stage vaccine, malaria-exposed Phase II trial in children or infants: safe, immunogenic, and biologic impact
12. Transmission-blocking vaccine, malaria-exposed village Phase I/II/III trial: safe and immunogenic (TBA)

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