GHIT SEmalvac6

Biomanufacture and preclinical development of the blood-stage malaria vaccine candidate SE36/cVLP

01.04.2025 bis 31.03.2027

Previous GHIT support contributed to the development of the promising blood-stage malaria vaccine
candidate based on the N-terminal domain of Plasmodium falciparum serine repeat antigen-5
(SE36). However, improved immunogenicity and reduced cost-of-goods/cGMP manufacture would
support and facilitate future implementation in the target populations. Higher-yielding SE36
production process with fewer purification steps and low endotoxin levels was obtained using the
Corynebacterium glutamicum technology, positively impacting the final cost-of-goods. Furthermore,
cVLP-coupled-SE36 induced the highest levels of antibodies observed in mice so far and has the
potential to improve the longevity of the immune response. Here, we propose to:
1. Manufacture a GMP batch of SE36.
2. Couple GMP-grade SE36 to GMP-grade cVLP to yield the SE36/cVLP vaccine candidate.
3. Conduct Good Laboratory Practice (GLP)-compliant nonclinical toxicology study for
SE36/cVLP + Sepivac SWE adjuvant.
4. Prepare clinical trial documentation for the conduct of a phase I/IIa (CHMI) trial for
SE36/cVLP (+/- Sepivac SWE) to assess safety, immunogenicity, and time-to-first episode of
clinical malaria in malaria-naïve vaccinated subjects.
Completion of (1)-(4) will set the stage for a first-in-human/CHMI trial to fast-track the SE36/cVLP
clinical development and enable manufacture of SE36/cVLP vials sufficient for phase IIb clinical
trials. With the potential of higher efficacy and longer durability with fewer doses required,
SE36/cVLP offers the possibility of a cost-effective blood-stage vaccine that could be deployed as a
stand-alone or potentially combined in a second-generation, multi-stage malaria vaccine.