About Aimmune TherapeuticsAimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing treatments for life-threatening food allergies. The company's Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to achieve meaningful levels of protection 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 and is currently being evaluated in Phase 3 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: the potential utility of the T H2A assay as a biomarker for oral immunotherapy; Aimmune's expectations regarding the potential benefits 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; the company'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 dependence on the success of AR101; the company's reliance on third parties for the manufacture of the company's product candidates; possible regulatory developments in the United States and foreign countries; and the company'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 March 31, 2017. 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.
Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today announced that its investigational treatment for peanut allergy, AR101, was highlighted in a recent publication by Benaroya Research Institute at Virginia Mason focused on the discovery of an immune cell subset — T H2A cells - that appears to be involved in the pathogenesis of allergies. These allergen-specific T cells are present in people with allergies but nearly entirely absent from people without allergies. The publication, which appeared in the August 2 issue of Science Translational Medicine, also reported that, in a small pilot experiment, AR101 treatment was associated with a significant reduction of T H2A cells in blood samples from a subset of peanut-allergic patients from Aimmune's ARC001 trial. AR101 is Aimmune's investigational biologic oral immunotherapy for desensitization of patients with peanut allergy. "We're hopeful that the identification of these T H2A cells will give researchers a tool to help improve medicine's ability to diagnose, monitor and treat allergies," said Dr. Wambre. "With the samples from the ARC001 trial, we saw targeted elimination of peanut-specific T H2A cells after only six months of AR101 therapy. Specifically, patients receiving AR101 experienced statistically significant reductions in T H2A cells, whereas there was no reduction in T H2A cells in patients receiving placebo. These T H2A cell reductions appeared to be associated with clinical response. Though this preliminary experiment was small, the results were clear, and we are excited to analyze the data from Aimmune's much larger, ongoing Phase 3 PALISADE population. If confirmed through subsequent work, we believe that the T H2A assay could have utility as a biomarker before and during oral immunotherapy." Benaroya Research Institute's work with the Aimmune samples potentially represents a new way to measure the allergy process and assess the effectiveness of specific treatments. In addition to the work on peanut allergy, the published article, "A phenotypically and functionally distinct human T H2 cell subpopulation is associated with allergic disorders," also reported on tests of allergies to grass and tree pollens, cat dander, dust mites, and mold, where T H2A played a pivotal role as well. The researchers found that these T H2A cells associated with stable allergic disease are terminally differentiated CD4+ T cells that exhibit several functional attributes that distinguish them from conventional T H2 cells. The article is available online at http://stm.sciencemag.org/content/9/401/eaam9171. "We're committed to advancing the understanding of food allergy and very pleased to see these data from our ongoing collaboration with Benaroya Research Institute and Dr. Erik Wambre published," said Daniel Adelman, M.D., Chief Medical Officer of Aimmune. "We look forward to further corroborating data in this area from the samples collected at key points of our ongoing Phase 3 PALISADE trial."