Ten years ago, Dr. James Baker, then chief medical officer of Food Allergy Research & Advocacy (FARE), told the organization to avoid talk of a food allergy “cure.”
“I recoiled at the word ‘cure.’ In fact, I banned it,” says Baker, now director of the Mary H. Weiser Food Allergy Center at the University of Michigan. “I thought it was giving unrealistic expectations.”
Back then, food allergy “treatment” typically meant strict avoidance of trigger foods and carrying epinephrine auto-injectors – not much else.
Flash forward a decade. The landscape has changed, dramatically. The Food and Drug Administration (FDA) has approved two food allergy treatments: Palforzia, the peanut oral immunotherapy (OIT), and omalizumab (Xolair), a monoclonal antibody that blocks IgE, the antibody central to allergic reactions.
In the meantime, researchers have made strides in understanding allergies at the cellular level. Newer therapies in development aim to go beyond IgE antibodies to target a broader network of immune cells. Some are already in clinical trials.
Given these advances, Baker is more optimistic than ever that science is on the cusp of major food allergy breakthroughs. He’s even ready to rethink that once taboo word.
“Can we develop tolerance in a way that would be perceived as ‘a cure’ by our patients? I think it’s time to start discussing this,” Baker told the 2025 M-FARA Research Symposium at University of Michigan in April.
What is a ‘Food Allergy Cure’?
Baker says the definition of cure matters. Is it being able to freely eat a previously allergenic food? Or does a “cure” require the complete absence of IgE antibodies to a food in the blood?
To him, a cure is “removing food allergy as a concern for an individual. Even if they remain sensitive, they no longer have the risk of life-threatening reactions, and they don’t have to worry about carrying epi,” he says.
Further it means, “you can eat the food if you want to. But you don’t have a requirement to eat it every day” to maintain tolerance.
Oral immunotherapy offers that possibility for some, says Dr. Wayne Shreffler, director of the Food Allergy Center at Massachusetts General Hospital.
During OIT, patients consume small, gradually increasing amounts of allergenic food to build tolerance. Once they reach a maintenance dose, patients remain on it for years, and potentially for life.
Palforzia is the only FDA approved OIT, specifically for peanut allergy. However, many allergists also offer OIT for other foods using allergen-containing grocery store items.
After OIT, if a patient passes a food challenge and their IgE drops to zero, Shreffler tells them, “please be intentional about keeping this food in the diet. But if things go well you may never need to see me again.” He treats them as he would someone who naturally outgrew their allergy. No epinephrine devices or school forms needed.
“That is a cure. A cure to me is making all evidence of an allergic response go away,” Shreffler said at the U-M meeting.
Still, undetectable IgE happens only occasionally with OIT, he says. For most, he prefers the term “remission.” Without regular exposure to a food, immune cells such as memory T and B-cells retain the potential to become reactive again.
Shutting Off Reactions for Good
Other research suggests it’s possible to permanently shut off reactions, at least in children.
The landmark LEAP study found that regularly feeding the peanut-containing snacks Bamba to infants with severe eczema reduced their risk of developing peanut allergy by 70 to 80 percent.
Of note, even already sensitized babies benefited. Among the infant participants, 19 percent already had positive skin tests to peanut, though they hadn’t shown allergy symptoms. Only 10 percent of those fed Bamba went on to develop the allergy, compared to 35 percent who avoided peanut and became allergic.
“That suggests that in somebody who is already on that path towards food allergy, you can interrupt it and turn them back to allowing them to eat the food,” Baker says.
The IMPACT trial also demonstrated that OIT desensitization could shut off reactions over the long-term in 21 percent of toddlers with peanut allergy. Remission rates were higher in 1-year-olds than 3-year-olds.
“The younger we get hold of people, the more pliable their immune system is,” Baker says.
Xolair and Testing Tolerance
In February 2024, the FDA approved omalizumab (Xolair). It’s the first medication for treating multiple food allergies in adults and children ages 1 and older.
Xolair works by binding to IgE antibodies floating in the bloodstream. This prevents IgE from binding to basophils and mast cells. During allergic reactions, those cells release histamines and inflammatory molecules, causing symptoms such as hives, itching, swelling, wheezing, nausea, and potentially anaphylaxis.
The OUtMATCH study that led to Xolair’s approval found that after four months of Xolair injections, 67 percent of allergic kids ages 1 to 17 could tolerate at least 600 milligrams of peanut protein, or 2½ peanuts. About 66 percent could tolerate about 1,000 mg of milk (2 tablespoons). Tolerance to other foods ranged from 67 percent for egg to 41 percent for cashew.
Omalizumab’s approval was limited to preventing reactions from accidental consumption. But subsequent studies have shown Xolair enables many people to consume substantially more of their allergen.
As some food allergy patients approach one year on Xolair, Dr. Scott Sicherer says he’s started offering food challenges to those interested in incorporating one or more of their allergens into their diet. “Treatment with Xolair is probably peaking at that 6-month to 12-month period,” says Sicherer, director of Jaffe Food Allergy Institute at Mount Sinai in New York.
“We’re at the point of offering food challenges to see how much they are interested in eating, and which foods they are interested in eating. This is the new world we’re in,” he said at the Michigan meeting.
Still, the need for ongoing injections and the cost of Xolair limit how many patients want to try it, Baker says.
OIT is also a big commitment. Side effects such a stomachaches and allergic reactions are common, especially during updosing. There’s still a great need for treatments that are easier on patients and longer lasting, he says.
Promise in the Therapy Pipeline
Scientists also now understand that an immune system primed to react because of IgE antibodies is only part of the allergy story. “We now know the process that causes food allergy is much more complex than this,” Baker says. “It goes through a series of steps.”
Research is now focused on understanding what other pathways are involved – and how to block them to prevent reactions.
Defects in proteins of the skin that ensure tight junctions between cells, aka “leaky” skin, has been shown in mice studies to lead to allergic sensitization. Certain genes may prompt the production of lots of IgE. The gut microbiome, our resident colonies of bacteria, appear to impact IgE production.
At the U-M meeting, researchers discussed some intriguing new approaches to treatment that are already being tested in people.
B cells produce IgE antibodies, but they are exceedingly rare – about 10 per 10 million white blood cells. This makes them hard to find. California-based IgGenix has developed a method of isolating IgE-producing B cells. They then locate the IgE, slice off a portion and turn it into an IgG antibody, which protects against reactions.
They’ve created batches of their new antibodies to “everything humans are allergic to,” from foods to mold to cat dander, says Derek Croote, PhD, IgGenix’s chief technical officer.
A Phase 1 trial of their first antibody treatment, IGNX001 for peanut allergy, has launched in Australia. It’s being tested at four dose levels in 32 people ages 15 to 55. Injections should offer almost immediate protection, Croote says. “So far so good. The safety data looks really nice.”
Vaccine That Targets T Cells
Another approach, by the Australia-based Aravax, is a peanut “vaccine,” PVX108. It targets T-cells, key immune system players that recognize allergens and activate B cells to produce IgE.
PVX108 contains seven synthetic protein fragments (peptides) derived from peanut allergen sequences. The peptides are too short to bind to IgE antibodies, so they don’t set off reactions. But the peptides do stimulate peanut-reactive T cells, retraining them to be less reactive. A study in peanut-allergic mice found the vaccine protected them from anaphylaxis.
A double-blinded, placebo-controlled Phase 2 trial of the peanut vaccine, conducted at 8 sites in the U.S. and six in Australia, is complete. Peanut-allergic adolescents and children got one dose of PVX108 for each of 12 months. They were then followed for 6 months to see if the effects last.
Participants now continue on into an extension study, where those on placebo will receive the active vaccine, Sara Prickett, PhD, Aravax’s chief scientific officer, told the researchers. Topline results are expected in 2026, and a Phase 3 trial is in the works.
“We believe this approach can result in much more efficient and long-lived tolerance induction at that T-cell level, which we anticipate will play out to reverse the course of the disease in people,” Prickett says. “We anticipate the T cells can actually work on other cells to dismantle the allergic reactivity in these patients.”
New 3-in-1 Antibody
The Swiss company Mabylon is also developing a new combination antibody that neutralizes peanut allergen. The antibody combines three, lab-engineered antibodies into a single, “tri-specific” molecule, says Niccolo Pengo, PhD, Mabylon’s chief scientific officer.
Called MY006, the antibody binds to the key sites on the peanut protein, preventing IgE from attaching to the allergen. This stops the activation of mast cells and basophils. MY006 successfully blocked allergic responses to peanut in the lab and mouse studies.
Mabylon plans to begin a Phase 1 clinical trial by the end of the year. [Update: see our article on that here.] The treatment would be given by injection, with two to four injections a year, Pengo says.
Other promising options, even earlier in the drug development pipeline, seek to suppress mast cell activity, Baker told the meeting. Bringing any of these treatments to patients is far from certain. Many treatments that look promising in the lab or in early studies don’t end up panning out.
Still, “there is hope,” Baker says. “This is a field that has been marked by an incredible amount of frustration, scientifically and commercially …. But I truly believe we are going to have breakthroughs in the next few years.”
Related Reading:
Dr. Robert Wood: Latest on Xolair for Food Allergies
Palforzia Launches Peanut Allergy OIT for Toddlers
Xolair Rival Aims for Food Allergy Dosing Every 2 to 3 Months
