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Publication : A comprehensive engineering strategy improves potency and manufacturability of a near pan-neutralizing antibody against HIV.

First Author	Sajadi MM	Year	2025
Journal	Structure	Volume	33
Issue	7	Pages	1150-1164.e8
PubMed ID	40373766	Mgi Jnum	J:386571
Mgi Id	MGI:8347828	Doi	10.1016/j.str.2025.04.016
Citation	Sajadi MM, et al. (2025) A comprehensive engineering strategy improves potency and manufacturability of a near pan-neutralizing antibody against HIV. Structure 33(7):1150-1164.e8

abstractText

Anti-HIV envelope broadly neutralizing antibodies (bnAbs) are alternatives to conventional antiretrovirals with the potential to prevent and treat infection, reduce latent reservoirs, and/or mediate a functional cure. Clinical trials with "first-generation" bnAbs used alone or in combination show promising antiviral effects but also highlight that additional engineering of "enhanced" antibodies will be required for optimal clinical utility, while preserving or enhancing Current Good Manufacturing Practices (cGMP) manufacturing capability. Here, we report the engineering of an anti-CD4-binding site (CD4bs) bnAb, N49P9.3. Through a series of rational modifications, we produced a variant, N49P9.6-FR-LS, that demonstrates enhanced potency, superior antiviral activity in combination with other bnAbs, low polyreactivity, and longer circulating half-life. Additional engineering for manufacturing produced a final variant, eN49P9, with properties conducive to cGMP production. Overall, these efforts demonstrate the feasibility of developing enhanced anti-CD4bs bnAbs with greatly improved antiviral properties as well as potential translational value.

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