New Phase I Peanut Allergy Immunotherapy Trial Produces Promising Results

According to science released at AAAAI, a new phase 1 peanut allergy immunotherapy trial results in no severe side effects, including anaphylaxis. The immunotherapy is designed to remove risks of acute reactions during treatment. 

The treatment, called PVX108, was designed to reset the patients immune system through a series of injections with increasing levels of peanut proteins known as peptides. Subjects were randomized to receive PVX108 or a placebo. 

 “New phase one data has demonstrated PVX108, a peptide-based immunotherapy for peanut allergy, has a highly favorable safety profile, even for patients with severe peanut allergies,” stated an AAAAI press release.

“PVX108 stands out by utilizing peptides that have been carefully selected from peanut proteins to induce tolerance to peanuts,” stated the authors. “By allowing these peptides to interact with immune cells, in the absence of whole protein which causes inflammation in allergic patients, those immune cells causing allergies may be reprogrammed to tolerate the allergen. The peptides are designed to be incapable of activating mast cells and basophils, so the risk of PVX108 causing severe reactions (including anaphylaxis) during treatment is greatly reduced.”

“This is an exciting time for clinicians who treat patients with peanut allergies as we now have several approaches being evaluated to treat this potentially life-threatening condition,” said Professor Robyn O’Hehir, MD, PhD, director of the department of respiratory medicine, Allergy and Clinical Immunology (Research), Central Clinical School, at Monash University in Melbourne, Australia.

“In particular, we are extremely encouraged by the favorable safety profile observed for PVX108 in this first clinical study of a peptide immunotherapy in peanut-allergic patients. In contrast to traditional specific immunotherapies which rely on exposing patients to allergenic proteins and carry the risk of dangerous side effects including anaphylaxis, PVX108 has been formulated to comprise only the small peptide components of peanut protein that are believed to be critical for inducing tolerance in T cells,” continued Professor Robyn, “ The peptides are synthesized to high quality standards and precisely target the underlying cause of disease. PVX108 does not contain whole peanut protein, so can be administered safely without dose escalation. While still early, the data suggest that monthly intradermal injections of PVX108 could transform how we treat patients with peanut allergies, including those with severe allergy.”

Phase I of the trial was designed to only test the safety of the vaccine. Phase II is intended to test the efficacy of the treatment but the authors are hopeful that this is a step in the right direction. 

“Peanut allergy is the most common cause of food allergy-related deaths in children, and there is an urgent need for safe, effective, and convenient therapies that address the underlying cause of this potentially fatal disease,” said Pascal Hickey, CEO of Aravax, the clinical stage biotechnology company based in Australia, that is currently focused on peanut allergies. —Edan Stanley