amtabafusp alfa

Amtabafusp alfa is a novel bispecific T-cell engager (BsTCE) developed for the treatment and potential cure of HIV-1 infection. It is designed using a recombinant fusion protein architecture that combines an engineered CD4 D1 domain, which targets the HIV-1 envelope (Env) glycoprotein, with an anti-CD3 T-cell engaging Fab fragment. This dual-targeting mechanism enables the redirection and activation of cytotoxic T cells to recognize and eliminate HIV-infected cells, including those within the latent reservoir. In Phase 1 clinical trials involving virologically suppressed people with HIV (PWH), amtabafusp alfa demonstrated dose-dependent CD3 receptor occupancy and a manageable safety profile, with common adverse events including low-grade cytokine release syndrome and reversible dermatologic reactions.

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amtabafusp