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In an article published today in Frontiers in Immunology, Immune Tolerance Network (ITN) leadership and clinical trial physicians review ITN's approach to the development of therapies that aim to establish tolerance in immune mediated diseases. They present concepts that have evolved from the ITN's clinical trial experience, with an emphasis on lessons learned from the mechanistic studies conducted as a part of these trials and strategies under development for the induction of tolerance.

In a study published on April 22, 2020 in JACI, data from ITN’s CATEEC clinical trial was used to investigate the connection between asthma and allergic disease and the novel coronavirus, SARS-CoV2 (COVID-19). The virus that leads to COVID-19, which has caused a global pandemic, uses the cell receptor angiotensin-converting enzyme-1 (ACE2) to enter human cells and cause infection. Interestingly, while several underlying respiratory conditions have been identified as risk factors for developing COVID-19 illness, asthma and allergy has been unexpectedly underrepresented in early epidemiologic studies of severe COVID-19 illnesses. The authors of this manuscript utilized three recent allergy and asthma studies to determine whether ACE2 expression differs in those with allergy and asthma.

The ITN article that reported the results of the CATEEC clinical trial, which compared clinical and biological responses to cat allergen exposure by nasal allergen challenge (NAC) or environmental exposure chamber (EEC) was selected to be an Editors’ Choice feature and was displayed on the American Academy of Allergy Asthma & Immunology (AAAAI) website.

The first patient first visit (FPFV) has occurred for ITN’s REBOOT clinical trial. REBOOT is a clinical study that aims to evaluate the safety and effectiveness of belimumab and intravenous rituximab at inducing remission of primary membranous nephropathy (MN) compared to rituximab alone.

The Immune Tolerance Network (ITN) has opened the BEAT-MS clinical trial for enrollment. BEAT-MS or “Best Available Therapy vs. Autologous Hematopoietic Stem Cell Transplant (AHSCT) for MS” will investigate high dose immunosuppression followed by AHSCT – a type of transplant using a patient’s own immune stem cells – compared to the best medical treatment currently available for multiple sclerosis (MS) in participants with relapsing MS.

This week in the article “How to Prevent Food Allergies,” Scientific American discusses the changes over the years to medical advice regarding children and dietary allergens. The article notes the results of the Immune Tolerance Network’s (ITN’s) LEAP (Learning Early About Peanut Allergy) Study that prompted the change in the American Academy of Pediatrics (AAP) guidance. Current recommendations suggest that high-risk infants should be systematically fed peanut products as early as four to six months of age in order to prevent the development of peanut allergy.

A follow-up analysis of the participants from ITN’s LEAP (Learning Early About Peanut Allergy) Study has identified a strong association between the development of peanut allergy and the MALT1 gene. These findings were recently published in the February 27th issue of the Journal of Allergy and Clinical Immunology.

ITN’s ACTIVATE (Vaginal Microbiome Exposure and Immune Responses in C-section Infants) has opened for recruitment. The goal of this pilot study is to investigate how differences in the microbiome of a baby may protect, or put them at risk, for allergies. To do this, the study will measure whether wiping babies born by C-section with their mother’s vaginal fluids (which contains potentially beneficial bacteria) right after birth will lower the risk of allergy development.

The Immune Tolerance Network (ITN) is currently developing a clinical trial to test a new treatment for vitiligo, an autoimmune disease in which the immune system attacks pigment containing cells in the skin leading to disfiguring white spots.

The ITN is currently seeking proposals for clinical trials for novel therapeutic approaches to induce B cell tolerance in patients who are donor-sensitized and/or to prevent sensitization. The therapeutic strategy must test specific immune mechanisms and must provide a clear pathway to future immune tolerance trials in solid organ transplantation.