The United States Food and Drug Administration has granted Fast Track designation for the drug candidate ASP0892 for the extenuation of severe hypersensitivity reactions due to peanut allergy, Astellas Pharma Inc. and Immunomic Therapeutics, Inc. announced. ASP0892 is a recent DNA vaccine program based on the investigational LAMP-Vax platform. A Phase I clinical trial to study the immune response, safety, and tolerability of ASP0892 in individuals who suffer from the allergy to peanuts has been initiated.
President Development of Astellas Bernhardt Zeiher, M.D. stated, “We are pleased that the FDA granted a Fast Track designation for ASP0892. 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.”
The founder and CEO of Immunomic Therapeutics William Hearl, Ph.D. stated, “In the United States alone, over three million people are affected by peanut allergy. 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.”
Peanut allergy can be deadly, with the potential of life-threatening anaphylaxis induced by the slightest exposure. There is currently no approved treatment for preventing peanut-induced allergic reactions in the event of accidental ingestion. Currently, patients manage their condition by carrying epinephrine auto- injectors and avoiding nuts altogether.
Astellas and Immunomic Therapeutics entered into an agreement in Jan. 2015 to grant Astellas the license for the Japan territory to develop and commercialize ASP4070. Consequently, in Oct. 2015, both companies entered into an agreement to the LAMP-Vax products for the treatment of all human allergic conditions. The LAMP-Vax technology might be able to boost the efficiency of DNA vaccines. Its function is to apply the body’s natural biochemistry to develop a more thorough immune response. The Phase I clinical trial of ASP4070 in Japan was concluded.