FDA Grants Fast Track Designation to Peanut Allergy Vaccine

Astellas Pharma and Immunomic Therapeutics recently announced that the FDA granted their investigational vaccine, ASP08922, fast track designation for the treatment of allergic reactions related to peanut allergies.

ASP0892 is a novel DNA vaccine program based on the LAMP-Vax platform, according to a press release from Astellas. The LAMP-Vax platform is a novel method to create vaccines that elicit an enhanced immune response. The companies have also initiated phase 1 clinical trials of the vaccine candidate to evaluate safety, tolerability, and immune response in adults with peanut allergies.

Fast track designation is granted in order to expedite the clinical trials and approval of investigational drugs that show the potential to treat conditions with few to no treatments.

“We are pleased that the FDA granted a Fast Track designation for ASP0892,” said Bernhardt Zeiher, MD, president, Development of Astellas. “Such designations reinforce the urgency of accelerating development programs for new treatments in these types of potentially life-threatening allergies. This milestone also reflects our commitment to addressing diseases and conditions with the highest of unmet medical needs.”

Peanut allergies can cause serious, life-threatening anaphylaxis resulting from even trace exposure. Approximately 1.3% of the US population, 1.4% of children, and 0.6% of adults have peanut allergies, according to the press release.

Since there is no preventative treatment, patients must avoid the allergen at all costs, which could potentially be difficult and impact quality-of-life. Patients also typically carry epinephrine auto-injectors, such as the EpiPen, in case of accidental exposure.

However, many individuals have expressed concern over affording the life-saving medication due to significant price increases over the past few years. In response to this, Mylan launched a generic version that costs 50% of the branded device, in hopes of expanding patient access.

This latest vaccine candidate is the result of a previously established agreement.

In the beginning of 2015, Astellas and Immunonmic Therapeutics entered into an agreement that allowed Astellas to develop and commercialize ASP4070 to treat allergies related to Japanese red cedar pollen, according to the press release. Phase 1 clinical trials of the vaccine have already been completed.

Later in 2015, the companies entered into a worldwide license agreement with LAMP-Vax products for allergies.

LAMP-Vax technology could potentially be used to enhance the effectiveness of DNA vaccines. The purpose of the technology is to use the body’s biochemistry to create a complete immune response, which could lead to novel vaccinations for diseases with no treatment, Astellas reported.

“In the United States alone, over three million people are affected by peanut allergy,” said William Hearl, PhD, the founder and CEO of Immunomic Therapeutics. “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.”