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BANNER trial - N6LS - Neutralizing Antibody Shows Promise


Jim Allen: in full:

In short:

--- Quote ---The experimental antibody, dubbed N6LS, demonstrated strong antiviral activity in a Phase II study.

A single infusion of N6LS, an experimental broadly neutralizing antibody (bnAb) from ViiV Healthcare, demonstrated robust antiviral activity as good as or better than that of other investigational bnAbs, offering hope for a new long-acting HIV treatment option, researchers reported at the HIV Drug Therapy meeting in Glasgow. Among 14 previously untreated study participants who received a high or low dose of N6LS, 13 had a virological response.

N6LS, also known as VH3810109, targets the CD4 binding site on HIV’s outer envelope, thereby preventing the virus from entering CD4 T cells. The antibody has demonstrated broad and potent neutralizing activity in laboratory studies.

Peter Leone, MD, of ViiV, and colleagues evaluated the safety, pharmacokinetics and antiviral activity of N6LS in the Phase IIa BANNER trial.

All participants received a single intravenous infusion of N6LS, either a weight-based dose of 40 milligrams per kilogram or a fixed dose of 280 mg, which works out to approximately 4 mg/kg—about one tenth the weight-based dose. The researchers assessed viral suppression while N6LS was used alone, known as monotherapy. People who did not reach a viral load below 0.5 log (about 3 copies/mL) by day 11 or experienced viral rebound after an initial response started antiretroviral therapy right away; all remaining participants started standard treatment at day 84.
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