FDA Fast-Tracks Investigational Peanut Allergy Vaccine

Following initiation of a Phase 1 trial, the United States Food and Drug Administration has fast-tracked a new treatment for peanut allergies, according to Astellas Pharmaceuticals Inc., the drug’s maker.

ASP0892 is an investigational vaccine for the treatment of peanut allergies, and little information about it is publicly available. Developed in collaboration with Immunomic Therapeutics using their LAMP-Vax platform, standing for Lysosomal Associated Membrane Protein. “Upon immunization with a LAMP-Vax™ DNA vaccine, [antigen processing cells] take up the DNA and produce the encoded protein sequence inside the cell as part of a fusion protein with LAMP,” according to Immunomic.

Astellas believes the drug will fill an unmet need for the three million Americans living with peanut allergies. "Such designations reinforce the urgency of accelerating development programs for new treatments in these types of potentially life-threatening allergies,” said Bernhardt Zeiher, MD, President, Development of Astellas, of the FDA’s fast-track decision.

The LAMP-Vax program is currently developing other allergy vaccines, including one for Japanese red cedar pollen, and since 2015 it has brought the two companies together in a licensing agreement.

Today’s press release does highlight its preliminary nature, stating that “the safety and efficacy of the agent discussed herein are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval and become commercially available for uses being investigated.” The Phase 1 trial of ASP0892 in adults aged 18 to 55 was only initiated in October, and is not expected to be completed until December of 2017.

Peanut allergy is among the most common food allergies in the United States, and is becoming more prevalent. According to Food Allergy Research and Education, food allergies result in over 200,000 emergency room visits per year, domestically, and such allergic reactions can be fatal.

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