BRISBANE, Calif.–(BUSINESS WIRE)–Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today announced that it will host an Investor Symposium in New York City on December 12, 2018. Aimmune’s senior management will discuss AR101’s clinical profile in peanut-allergic patients and the company’s preparations for a potential 2019 U.S. commercial launch. The event will also bring together leading expert allergists to discuss the emerging treatment landscape in peanut allergy, including the recent New England Journal of Medicine1 publication of the landmark PALISADE trial of AR101, the largest and only successful phase 3 peanut allergy immunotherapy trial to date. A question and answer session will follow the formal presentations. AR101 is Aimmune’s investigational oral biologic desensitization therapy for peanut allergy, which has received the FDA’s Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4–17 years of age.
Guest Expert Allergy Panel
Christina Ciaccio, MD, MSc, is an Associate Professor of Pediatrics and Medicine and Interim Chief, Allergy/Immunology, and Pediatric Pulmonology and Sleep Medicine at the University of Chicago. Dr. Ciaccio is passionate about understanding how nutrition (prebiotics) and microbial exposures (probiotics) affect IgE sensitization. She was a 2011 recipient of the Young Faculty Award from the American College of Allergy, Asthma, and Immunology and the 2013 recipient of the Paul Henson Clinical Scholar Award for research in immunology and inflammation. In addition, she is a past president of the Greater Kansas City Allergy Society. She currently directs the food allergy program at the University of Chicago Medicine. Dr. Ciaccio is a clinical investigator for AR101 clinical trials in the United States.
George du Toit, M.B., B.Ch., is a Professor of Pediatric Allergy at King’s College London, Guy’s and St. Thomas’ NHS Foundation Trust. Prof. du Toit was the lead author of the landmark “Learning Early about Peanut Allergy” (LEAP) trial and follow-on “Persistence of Oral Tolerance to Peanut” (LEAP-On) trial, studies which led to new guidelines for the prevention of peanut allergy in many countries including the United States. His research interests concern the prevention of food allergy, urticarial disorders, exercise and allergy, and allergy to medications in childhood. He served as Chair of the Pediatric Section of the European Academy of Allergy and Clinical Immunology (EAACI) from 2015 to 2017. Prof. du Toit is a member of the Scientific Advisory Board for Aimmune Therapeutics and a clinical investigator for AR101 clinical trials in the United Kingdom.
Lawrence D. Sher, MD, is a board certified pediatric and adult allergist-immunologist who opened Peninsula Research Associates in 1999 and has served as principal investigator for more than 200 clinical research trials including multiple food allergy studies. Dr. Sher is also a founding and medical director of Palos Verdes Medical Group, a multi-specialty practice and urgent care center encompassing pediatrics, AD/HD, internal medicine and adult and pediatric asthma, allergy and immunology. He currently is a member of the Immunotherapy Committee and Practice Management Committee for the American Academy of Allergy, Asthma and Immunology. Dr. Sher has been practicing in Rolling Hills Estates for the past 25 years and is a former director of the South Bay region of the Food Allergy and Anaphylaxis Network. Dr. Sher is a clinical investigator for AR101 clinical trials in the United States.
Stephen A. Tilles, MD, is Clinical Professor at the University of Washington, has practiced allergy in the community setting for 23 years, and has served as principal investigator for more than 140 clinical research studies including food allergy. He was previously an Assistant Professor of Medicine and Pediatrics and Director of the Allergy and Asthma Clinic at the Oregon Health Sciences University. Dr. Tilles is a past president of the Western Society of Asthma, Allergy and Immunology and the Oregon Society of Allergy, Asthma, and Immunology. He served as President of the American College of Allergy, Asthma, and Immunology in 2016 and is a member of the American Board of Allergy and Immunology. Dr. Tilles has been a clinical investigator on AR101 clinical trials in the United States, currently serves as a consultant to Aimmune Therapeutics, and is expected to become an employee of the company in 2018.
Brian Vickery, MD, is a pediatric allergist-immunologist whose clinical and research efforts focus on understanding the pathophysiology of food allergies and anaphylaxis, and developing new therapies to treat them. He has studied all aspects of therapeutic development, from preclinical murine models to phase 3 trials, and is particularly focused on the intersection of translational and outcomes research in generating rational, evidence-driven treatment strategies. He is currently an Associate Professor of Pediatrics at Emory University and the founding Director of the Food Allergy Center at Children’s Healthcare of Atlanta. Dr. Vickery is a member of Aimmune Therapeutic’s Scientific Advisory Board.
Event and Webcast Details
The Investor Symposium will be held on Wednesday, December 12, 2018, from 8:00-10:30 a.m. Eastern Time in New York City. Analysts and investors may register for the event by contacting LifeSci Advisors, LLC, at firstname.lastname@example.org. A live webcast of the event will be available and may be accessed in the Investor Relations section of Aimmune’s website at www.aimmune.com under the Events page. A replay will be available for at least 30 days.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a biopharmaceutical company developing treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to provide meaningful levels of protection against allergic reactions resulting from accidental exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens. Aimmune’s first investigational biologic product using CODIT™, AR101 for the treatment of peanut allergy, has received the FDA’s Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4–17 years of age. Aimmune plans to submit regulatory filings for marketing approval of AR101 in the United States and Europe based on data from the pivotal Phase 3 PALISADE clinical trial of AR101, which in 4–17-year-old subjects met its primary and key secondary endpoints, and additional ongoing and completed AR101 clinical trials. For more information, please see www.aimmune.com.
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Aimmune’s expectations regarding the potential benefits of AR101; Aimmune’s expectations regarding the potential commercial launch of AR101, including the timing of a potential approval of AR101; and Aimmune’s expectations regarding potential applications of the CODIT™ approach to treating life-threatening food allergies. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the expectation that Aimmune will need additional funds to finance its operations; Aimmune’s or any of its collaborative partners’ ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Aimmune’s or any of its collaborative partners’ clinical trials will not be successful; Aimmune’s dependence on the success of AR101; Aimmune’s reliance on third parties for the manufacture of Aimmune’s product candidates; possible regulatory developments in the United States and foreign countries; and Aimmune’s ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Aimmune’s most recent filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2018. All forward-looking statements contained in this press release speak only as of the date on which they were made. Aimmune undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
This press release concerns a product that is under clinical investigation and that has not yet been approved for marketing by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). It is currently limited to investigational use, and no representation is made as to its safety or effectiveness for the purposes for which it is being investigated.
- Vickery BP, Vereda A, Casale TB, et al. AR101 oral immunotherapy for peanut allergy. New Engl J Med 2018; DOI: 10.1056/NEJMoa1812856.