— 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160621005527/en/
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
