A GLYCOLIPID ADJUVANT 7DW8-5 FOR MALARIA VACCINES

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The goal of this contract project is to develop the glycolipid-based adjuvant for human use, with initial indications for a malaria vaccine. The scope of our product development project is to develop our novel CD1d-binding natural killer T (NKT) cell-stimulatory glycolipid, called 7DW8-5, as a versatile vaccine adjuvant. Initial partner vaccines are based on a nucleic acid-based priming and whole parasite-based boosting liver-targeted malaria vaccine. We have published that that the 7DW8-5 glycolipid significantly increases the immunogenicity and efficacy of the nucleic acid prime-and-parasite trap malaria vaccines in a mouse model and have additional data showing that the adjuvant simplifies formulation and administration of this vaccine. Here, we will evaluate non-GMP-grade 7DW8-5 for formulation, solubility, release, stability, and toxicology. We will also confirm safety, immunogenicity, and efficacy of the 7DW8-5/malaria vaccine in non-human primates (NHPs). Lastly, we will develop a pre-IND regulatory package for future 7DW8-5 FDA review.