Aimmune Therapeutics to Host Investor Symposium on the Future of Treating Peanut Allergy with Leading Expert Allergists on Wednesday, December 12th
Business Wire 6-Dec-2018 8:00 AM
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 morgen@lifesciadvisors.com.
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.
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 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.
References
-
Vickery BP, Vereda A, Casale TB, et al. AR101 oral immunotherapy for
peanut allergy. New Engl J Med 2018; DOI: 10.1056/NEJMoa1812856.
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