Scientific Core One

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Abstract Scientific Core One has the responsibility of creating, validating, and providing R&D-grade HIV-Env immunogen-expressing self-amplifying RNAs (saRNAs) complexed with the nanostructured lipid carrier (NLC) delivery vehicle to project leads at Fred Hutchinson Cancer Research Center for in vivo testing as described in Scientific Project One. AAHI’s saRNA/NLC vaccine platform has previously demonstrated robust immunogenicity against many antigen targets, including HIV, and unparalleled stability. This technology will now be adapted to deliver the HIV immunogens of our partners at the Fred Hutchinson Cancer Research Center. Scientific Core One activities include design and cloning of the saRNA template DNA plasmids, saRNA production using well-characterized and validated in vitro transcription and purification processes, and manufacturing of the NLC delivery formulation. Upon successful saRNA and NLC manufacture, Scientific Core One will complex of saRNA/NLC vaccine and test these vaccines in vitro to verify successful saRNA replication and antigen production. Scientific Core One will also provide transfected cell materials to Scientific Core Two for immunogen antigenicity testing. Finally, the stability of these R&D-grade saRNA, NLC, and complexed saRNA/NLC materials will be verified using standard stability testing techniques to gather necessary data to enable GMP manufacturing by Scientific Project Two, successful filing of an IND and completion of a Phase I clinical trial.