Tokyo, December 20, 2016 - Astellas Pharma Inc. (President and CEO: Yoshihiko Hatanaka, “Astellas”) and Immunomic Therapeutics, Inc. (Founder & CEO: William Hearl, Ph.D., “Immunomic Therapeutics”) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the drug candidate ASP0892 for the mitigation of severe hypersensitivity reactions due to peanut allergy. ASP0892 is a new DNA vaccine program based on the investigational LAMP-Vax platform. A Phase I clinical trial to evaluate the safety, tolerability and immune response of ASP0892 in adults allergic to peanuts has been initiated.

“We are pleased that the FDA granted a Fast Track designation for ASP0892,” said Bernhardt Zeiher, M.D., 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.”

“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,” said William Hearl, Ph.D., the founder and CEO of Immunomic Therapeutics.

Peanut allergy can be a fatal food-related allergy with potential of life-threatening anaphylaxis induced by trace exposure. The estimated prevalence in the US for peanut allergy is reported as 1.3% overall, 1.4% in children, and 0.6% in adults[1]. There is no currently approved treatment for preventing peanut-induced allergic reactions in the event of accidental ingestion. Currently patients manage their condition by strict allergen avoidance and carrying epinephrine auto-injectors for use in case of accidental exposure. In the case of children, this vigilance must also be maintained by parents, schools, and other guardians.

In January 2015, Astellas and Immunomic Therapeutics entered into an agreement to grant Astellas the exclusive license for the Japan territory to develop and commercialize ASP4070, currently under investigation and designed to treat allergies induced by Japanese red cedar pollen. Thereafter, in October 2015, both companies entered into an exclusive worldwide license agreement to the LAMP-Vax products for the treatment or prevention of any and all human allergic diseases. The LAMP-Vax technology may be able to enhance the effectiveness of DNA vaccines. Its purpose is to utilize the body’s natural biochemistry to develop a more complete immune response, which could potentially enable effective vaccinations for a wide spectrum of diseases with unmet need. The Phase I clinical trial of ASP4070 in Japan was completed.

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.

###


[1] Sicherer, 2011