Bispecific 10E8.4/iMab broadly neutralizing antibody in people with or without HIV-1: a partially randomized phase 1 trial

07 Jul 20264 min read0 viewsJournal Feed

GIST (Key Takeaways)

Broadly neutralizing antibodies (bnAbs) are a promising tool for HIV prevention and treatment. Here we conducted a first-in-human, phase 1 trial of the bispecific 10E8.4/iMab antibody, which consists of a 10E8.4 arm binding the HIV-1 envelope glycoprotein membrane-proximal external region and an ibalizumab (iMab) arm binding the human CD4 molecule.
10E8.4/iMab was administered intravenously (IV) or subcutaneously (SC). Safety/tolerability within 2 weeks of 10E8.4/iMab administration (primary outcome) and the pharmacokinetics (PK), antiviral activity, induction of anti-10E8.4/iMab antibodies, longitudinal CD4 + and CD8 + T cell counts and long-term safety (secondary outcomes) were evaluated.
54 participants living with HIV (PLWH) or without HIV (PLWoH) received 10E8.4/iMab or placebo. In arm 1, PLWoH received 10E8.4/iMab 0.3 mg kg −1 IV, 1 mg kg −1 SC, or 1 mg kg −1 IV ( n = 3 each).
In arm 2, PLWoH received 10E8.4/iMab 3 mg kg −1 IV, 10 mg kg −1 IV or 30 mg kg −1 IV ( n = 6 each).