Project-002

Abstract: The goals of Scientific Project Two are the manufacturing and release of two cGMP saRNA/NLC HIV-1 Env-derived vaccine candidates and the establishment of an ICH-compliant stability program for these vaccines. The two vaccines consist of a self-amplifying RNA (saRNA) encoding two HIV-1 Env immunogens (426c.Mod.Core and HxB2.WT.Core). The vaccines will be producing either the secreted nanoparticle form or the membrane-anchored forms of these two HIV-1 Env immunogens, depending on the findings made in Scientific Project One. The vaccines will be formulated with a nanostructured lipid carrier (NLC), which stabilizes the RNA and delivers it to cells that amplify it and express the antigen in vivo. The bulk drug substance (BDS) RNA is formulated with excipients, complexed with NLC BDS, sterile-filtered, and vialed to produce the final drug products (DP), which are the vaccine candidates. AAHI’s GMP Operations has experience with manufacturing and releasing saRNA and NLC BDS, and DPs or investigational Yellow Fever and SARS-CoV-2 vaccines. To date, AAHI GMP has manufactured four saRNA BDS, four NLC BDS, and two final drug products using our established processes. We are perfectly positioned to manufacture the HIV-1 Env immunogens discussed in this application within the period of funding.