Peanut Allergy Vaccine Gets FDA Fast Tracked

DNA Vaccine candidate ASP0892 approved for clinical trials for the mitigation of severe hypersensitivity reactions due to peanut allergy

no peanuts

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for a Phase I clinical trial to evaluate the safety, tolerability and immune response of ASP0892 in adults allergic to peanuts.

There is no approved method for preventing peanut-induced allergic reactions.

Patients currently have to deal with their allergies by staying away from allergens and carrying epinephrine auto injectors such as an “EpiPen.” Even a small exposure to peanuts can cause those allergic to have a severe or even life-threatening reaction when eaten accidentally.

Peanut allergy is a type of food allergy to peanuts, but different from nut allergies. The physical symptoms of allergic reaction can include itchiness, urticaria, swelling, eczema, sneezing, asthma, abdominal pain, drop in blood pressure, diarrhea, and cardiac arrest.

Peanut allergy can be a fatal food-related allergy with potential of life-threatening anaphylaxis induced by trace exposure. In the case of children, this vigilance must also be maintained by parents, schools, and other guardians.

Anaphylaxis may occur due to a type I hypersensitivity reaction of the immune system in susceptible individuals.

"We are pleased that the FDA granted a Fast Track designation for ASP0892," said Bernhardt Zeiher, M.D., President, Development of Astellas Pharma, Inc.

"In the United States alone, over three million people are affected by peanut allergy. The estimated prevalence in the US for peanut allergy is reported as 1.4% in children, and 0.6% in adults.”

“We are glad that the FDA made this decision regarding the early LAMP-Vax research as applied to peanut allergy and look forward to further work from Astellas on this important effort," said William Hearl, Ph.D., the founder and CEO of Immunomic Therapeutics.

The LAMP-Vax is a next-generation DNA vaccine designed to stimulate an immune response against a particular protein, injecting the DNA encoding the protein rather than the protein itself.

The FDA's Fast Track program is designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and that demonstrate the potential to address an unmet medical need.

Astellas' vaccine is in a Phase I study testing its safety and immune response in adults who are allergic to peanuts. Aimmune Therapeutics’s peanut allergy therapeutic vaccine candidate AR101 is now in Phase 3 clinical trial.

No conflicts of interest were reported, nor were vaccine costs presented.