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N6LS – a new super antibody

A super antibody called N6LS (code named VH3810109) is being developed by ViiV Healthcare. It has recently been tested in a phase II study in people who have not previously used HIV treatment. The antibody binds to HIV and blocks it from attaching to CD4 receptors on T-cells. A previous study suggests that it has potent anti-HIV activity in people and is generally well tolerated.

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Usually, prior to entering an antibody-based study, participants are screened for HIV that is susceptible to the antibody. However, in the present study, perhaps because of difficulty obtaining the screening assay, participants’ blood samples were screened after the study began.

In the present study, the antibody was given via intravenous infusion or subcutaneous injection.

Researchers tested a single application of the antibody to assess its anti-HIV effect. Doses of the antibody included the following:

  • 700 mg given intravenously (10 mg/kg)
  • 70 mg given intravenously (1 mg/kg)
  • 700 mg given via subcutaneous injection (10 mg/kg)

The average profile of the 62 people who entered the study was as follows:

  • age – 30 years
  • 94% male, 6% female
  • major ethno-racial groups: White – 61%; Black – 18%
  • CD4+ count – 383 cells/mm3
  • viral load – 25,000 copies/mL
  • body mass index (BMI) – 25 kg/m2

Results

In general, the higher the dose of antibody, the greater the suppression of HIV. The dose of 10 mg/kg given intravenously resulted in about a 1.5-log decrease in viral load. When the antibody was given via subcutaneous injection, viral load did not fall significantly.

Researchers are planning another study called “Embrace” with the antibody in combination with the drug cabotegravir. In Embrace, researchers plan to also use an enzyme called hyaluronidase. This enzyme allows the body to store greater amounts of fluid when injected subcutaneously. In Embrace, researchers hope to screen people for having HIV that is susceptible to the antibody prior to starting study drugs.

—Sean R. Hosein

REFERENCE:

Leone P, Ferro A, Lupo S, et al. VH3810109 (N6LS) in Adults With HIV-1 Who Are ART-Naive: Phase IIa BANNER Efficacy Data. Conference on Retroviruses and Opportunistic Infections, March 3-6, 2024. Abstract 117.