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Aimmune Therapeutics Appoints Daniel Adelman, M.D., as Chief Medical Officer

— New CMO Is a Seasoned Clinical Development Leader and Food Allergy and Immunology Expert —

BRISBANE, Calif.--(BUSINESS WIRE)--Jun. 21, 2016-- Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing CODIT™ (Characterized Oral Desensitization ImmunoTherapy) treatments for life-threatening food allergies, today announced the appointment of Daniel C. Adelman, M.D., as Chief Medical Officer. Dr. Adelman, a notable allergist and immunologist, officially assumed his new role on June 16, 2016.

“It’s an honor to have a leader with such a deep understanding of the food allergy field choose to join Aimmune. Dan brings us the rare combination of extensive industry experience in clinical development and authority as a respected allergy and immunology academic,” said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. “Dan also helped inspire the formation of Aimmune, as he was among the food allergy leaders who participated in the 2011 research retreat that led to our founding. We’re delighted to have his expertise on our executive team as we carry out our Phase 3 PALISADE trial for peanut allergy and as we look toward further development, both for peanut allergy and other food allergies.

“At the same time, we want to express our gratitude to Dr. Robert Elfont, whose great insights and hard work helped us execute successfully on our Phase 2 studies, build our impressive clinical team, and design and launch our Phase 3 PALISADE trial,” said Dr. Dilly. “Now that Rob has returned to his consulting practice, we’re pleased that he will continue to be available to us as a valuable resource.”

Until resigning to become Chief Medical Officer of Aimmune, Dr. Adelman was a member of the prestigious Research Advisory Board of Food Allergy Research & Education (FARE), the world’s largest private funder of food allergy research. For several years, he was actively involved in reviewing FARE’s research funding and helped to shape the organization’s overall research strategy.

“We’re deeply grateful for the contributions Dan has made as a member of our Research Advisory Board, and we’re pleased to see him join Aimmune,” said James R. Baker, Jr., M.D., FARE CEO and Chief Medical Officer. “Dan’s leadership and clinical expertise will be great assets as Aimmune continues to progress toward what would be the first FDA-approved oral immunotherapy for food allergies. This treatment could make a great impact on the lives of millions of people at risk from peanut allergy.”

Most recently, Dr. Adelman spent seven years as Chief Medical Officer and Senior Vice President of Development at Alvine Pharmaceuticals, a biopharmaceutical company focused on autoimmune and inflammatory diseases, particularly celiac disease. He held the same positions, as Chief Medical Officer and Senior Vice President of Development, during five years at Sunesis Pharmaceuticals, Inc. Earlier, Dr. Adelman served in various roles at Pharmacyclics, Inc., including Vice President of Clinical Operations and Biometrics, and was a Clinical Scientist at Genentech, Inc. Dr. Adelman began his career as an Assistant Professor of Clinical Medicine in the Division of Allergy and Immunology at the University of California, San Francisco, School of Medicine, where he was also Director of Clinical Allergy and Immunology. He has now taught and practiced at UCSF for more than 25 years, as he remained on faculty upon entering industry and is currently an Adjunct Professor of Medicine. Dr. Adelman holds a bachelor’s degree in biology from the University of California, Berkeley, and earned his M.D. from the University of California, Davis.

“Over the course of my academic and industry careers, the increased prevalence of food allergies has been alarming,” said Dr. Adelman. “I have been tracking the impressive work that the team at Aimmune has done in conjunction with leading academic investigators and advisors in the field, and I’m thrilled to be joining them in their efforts to develop treatments for patients with food allergies. Collectively, we are making advances in understanding and, ultimately, treating serious, potentially life-threatening food allergies. Aimmune has emerged as a leader in the field of food allergy by working with all stakeholders towards a common goal of achieving clinically meaningful improvements in the lives of our food-allergic patients.”

Dr. Adelman also serves on several clinical scientific advisory boards and on the editorial boards of Clinical Immunology and Journal of Clinical Immunology. He served on the editorial board of the Journal of Allergy and Clinical Immunology for five years and has published extensively in allergy, clinical immunology and autoimmunity, and oncology.

About Food Allergies

Food allergies are a significant and growing health problem in the United States, Europe and throughout the developed world. It is estimated that more than 30 million people in the United States and Europe have a food allergy, and more than five million people in the United States and Europe have peanut allergy, including more than two million children. The prevalence of peanut allergy in children in the United States is estimated to have tripled between 1997 and 2008, and experts believe it has continued to rise since 2008. For people living with food allergies, certain foods can cause severe allergic reactions, including potentially life-threatening anaphylaxis. There are no approved medical therapies to cure food allergies or prevent their effects. Currently, food-allergic patients manage their condition by strict allergen avoidance and carrying epinephrine auto-injectors for use in case of accidental exposure. Thus, in addition to the unmet medical need, food allergies can impose a significant quality-of-life burden. For more information, please see www.foodallergy.org and www.niaid.nih.gov/topics/foodallergy.

About AR101 and CODIT™

Aimmune Therapeutics is developing AR101 as a potential desensitization therapy for patients with peanut allergy to provide them with protection from reactions to peanut allergens at a level believed to substantially exceed the amount typically encountered in an accidental exposure. AR101 maintains the complete range of natural peanut proteins, which are rigorously analyzed and combined with pharmaceutical-grade ingredients to ensure that each dose has consistent amounts of peanut protein with well-defined concentrations of peanut allergens, especially the three key allergenic proteins (Ara h1, h2 and h6). Patients ingest AR101 mixed into small amounts of palatable, age-appropriate food.

AR101 is part of Aimmune’s approach to treating food allergies using its Characterized Oral Desensitization ImmunoTherapy, or CODIT™, system. The CODIT system leverages extensive independent scientific research on oral immunotherapy, or OIT, demonstrating that food allergy patients can be desensitized to food allergens by being administered well-defined, gradually increasing doses of the allergen over a period of months. Aimmune’s CODIT system is designed to precisely control the amounts of the allergens administered in a systematic dosing regimen, beginning with very low doses of the allergens. Once a patient attains a clinically meaningful level of desensitization, the patient continues to take a daily maintenance dose of the CODIT system product in order to maintain the desensitization.

About Aimmune Therapeutics

Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) system, an approach to oral immunotherapy (OIT), uses rigorously characterized product candidates with gradual, controlled up-dosing protocols to obtain clinically meaningful desensitization to food allergens. Aimmune’s first CODIT product, 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’s Phase 3 trial of AR101, PALISADE, is now enrolling patients. For more information, please see www.aimmune.com.

Forward-Looking Statements

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 development efforts; Aimmune’s expectations regarding the potential benefits of AR101; and Aimmune’s expectations regarding potential applications of its CODIT™ system. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: Aimmune’s ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Aimmune’s clinical trials will not be successful; Aimmune’s reliance on third parties for the manufacture of its product candidates and the conduct of its Phase 3 clinical trial for AR101; 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 the Quarterly Report on Form 10-Q for the period ended March 31, 2016, filed on May 16, 2016. 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.

Source: Aimmune Therapeutics, Inc.

Aimmune Therapeutics, Inc.
Investors
Laura Hansen, Ph.D., 650-396-3814
lhansen@aimmune.com
or
Media
Stephanie Yao, 650-351-6479
syao@aimmune.com