Posted by on March 6, 2019 12:44 am
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Source: No Dangerous Effects With Peptide-Based Peanut Immunotherapy – Medscape

A monthly injection of PVX108, a peptide-based immunotherapy for peanut allergy, could offer lasting protection from peanut-allergic reactions more safely than oral immunotherapies, early research from an Australian team suggests.

Unlike oral immunotherapies that can lead to dangerous adverse 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, Robyn O’Hehir, MD, PhD, from Monash University in Melbourne, explained in a news release.

“The peptides are synthesized to high-quality standards and precisely target the underlying cause of disease,” she points out.

In their phase 1 study — presented at the American Academy of Allergy, Asthma and Immunology 2019 Meeting in San Francisco — O’Hehir and her colleagues assessed the safety and tolerability of PVX108 in humans.

In the first part of the study, eight groups of six peanut-allergic adults were randomized to receive a single injection of PVX108 or placebo. A dose of 0.05 nmol was administered to the first group, which was then escalated as each successive group was randomized, to a final dose of 150 nmol.

In the second part of the study, 18 patients were randomized to six injections of PVX108 150 nmol or placebo administered over 16 weeks.

There were no clinically concerning adverse events. Of the mild or moderate transient events reported, most were mild injection-site reactions.

“While still early,” O’Hehir added, “the data suggest that monthly intradermal injections of PVX108 could transform how we treat patients with peanut allergies, including those with severe allergy.”

Transforming Treatment

“The phase 1 trial of PVX108 showed that it is safe and well tolerated in peanut-allergic individuals,” said Mark Larché, PhD, from McMaster University in Hamilton, Ontario, Canada, who was asked to comment on the study.

The big difference with this type of immunotherapy is that it doesn’t cause a serious reaction, “so we can give a much higher dose of these peptides to patients,” he told Medscape Medical News.

“I like to talk about the approach as curative, instead of as a complete cure,” he said. This would be akin to what you achieve with traditional allergy shots for hay fever.

The therapy clearly changes the nature of the T-cells. “It switches them back to the kind of pattern you see in a healthy individual. That’s ultimately what we want — to get those T-cells back to normality,” he explained.

A study of PVX108 in a mouse model conducted by Larché and his colleague was also presented at the meeting.

“When treated with peptides, we could prevent anaphylaxis in mice,” he reported.

O’Hehir is an advisor to Aravax. Larché is a consultant for Aravax and Adiga Life Sciences.

American Academy of Allergy, Asthma and Immunology (AAAAI) 2019 Meeting: Abstracts L15 and L31. Presented February 25, 2019.

Follow Medscape on Twitter @Medscape and Ingrid Hein @ingridhein

Published at Tue, 05 Mar 2019 21:22:07 +0000