PVX108 Raises Peanut Tolerance in Children After Monthly Doses

A monthly shot helped children with peanut allergy tolerate far more peanut in a Phase 2 trial whose topline results Aravax announced on November 12, 2026. The drug, PVX108, is a peptide immunotherapy given intradermally, into the skin, once every four weeks for 12 months. In the primary cohort of children ages 4 to 11, the higher dose raised the maximum tolerated dose of peanut 2.4-fold from baseline. Placebo managed 1.2-fold. The trial met its primary endpoint, and the full results are being presented on November 14 at the American College of Allergy, Asthma and Immunology meeting in Phoenix.

The study, registered as NCT05621317, ran at 14 trial sites in the United States and Australia. It enrolled 95 participants in two cohorts: a pilot safety cohort of 24 adolescents ages 12 to 17, and the primary efficacy and safety cohort of 71 children ages 4 to 11. The younger cohort received PVX108 at 5 nanomole or 50 nanomole doses, or placebo, in a randomized, double-blind design. The endpoint that mattered was a supervised food challenge at month 12: how much peanut a child could eat before reacting.

Completion numbers tell their own story about tolerability. Of the 71 children in the primary cohort, 68, or 96 percent, finished treatment and the month 12 food challenge. There were no withdrawals due to study treatment. When the trial ended, 59 of the 68 completers, 87 percent, chose to continue into a 12-month open-label extension study. Families don't volunteer for another year of injections in a trial that made their children miserable.

PVX108 works differently from the peanut therapies already on the market. It uses proprietary peptides designed to retrain the immune system's T cells to tolerate peanut, without carrying the whole peanut proteins that trigger acute allergic reactions. That's the design problem every food-allergy immunotherapy faces: the treatment is made of the thing the patient reacts to. Aravax's bet is that short peptides deliver the retraining signal with less of the danger, and the therapy already holds FDA Fast Track designation.

The durability signal may matter most. Follow-up food challenges six months after treatment ended, at the 18-month mark, showed the gains in peanut tolerance were maintained or, in some children, increased without further doses. A therapy whose effect survives its own end is a different proposition from one a child must take indefinitely, and it's the result allergists will press on when the full data are presented in Phoenix by Brian P. Vickery of Children's Healthcare of Atlanta and Emory University.

The cautions are standard and real. These are company-reported topline results from a small Phase 2 cohort, not a peer-reviewed publication, and PVX108 isn't approved anywhere. Larger trials have to confirm the effect and map the safety profile before any regulator decides. Extension results aren't expected until the second half of 2027. But for a field where the standard advice is still strict avoidance and an epinephrine pen, a monthly shot that doubled tolerated dose and held its gains is a result worth the room it's getting.