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The ITN's LEAP study manuscript was selected by the New England Journal of Medicine as one of the most notable articles of 2015. The LEAP study provided conclusive evidence that early consumption of peanut by high-risk infants prevents the development of peanut allergy later on.

A manuscript published in the November 25, 2015 online issue of Science Translational Medicine reported no serious adverse reactions in the first phase 1 safety trial of a new immunotherapy approach investigating regulatory T cells (Tregs) for the treatment of type 1 diabetes (T1D). The clinical study was conducted at UCSF by Stephen E. Gitelman, MD, and Kevan C. Herold, MD, and was designed and analyzed by Jeffrey A. Bluestone, PhD. The Immune Tolerance Network helped support the mechanistic studies associated with this trial.

The ITN is currently seeking proposals for clinical tolerance trials in solid organ transplantation. We are interested in trials using cell therapy to acheive tolerance in solid organ (liver and kidney) transplant. The ideal proposal should have a testable mechanism of tolerance induction and a strategy for assays to investigate this mechanism.

The Immune Tolerance Network (ITN) opened the OPTIMAL Study for liver transplant recipients at the first clinical site, the University of California, San Francisco on Monday, October 26, 2015. The OPTIMAL Study (Operational Tolerance Biomarkers of Immune Senescence and Lymphocyte Exhaustion Following Adult Liver Transplantation) will enroll 60 adult liver transplant recipients. These recipients will undergo supervised, gradual withdrawal of their immunosuppressive medications.

A potential biomarker of tolerance in kidney transplant recipients was found to be stable for up to three years in a cohort of 32 operationally tolerant kidney recipients from the ITN’s FACTOR study. The signature is characterized by the increased expression of two genes associated with B cells, suggesting a potential role of B cells in regulating the immune response to the kidney. The results were reported on October 13th in the American Journal of Transplantation.

The Immune Tolerance Network (ITN) completed enrollment this week for the IMPACT Study in peanut allergy. There are 144 participants enrolled in the IMPACT Study (Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children), which tests whether giving increasing doses of peanut protein (oral immunotherapy) over a two-year period can induce desensitization to peanut.  The trial will also address whether extended oral immunotherapy can create long-lasting tolerance to peanut. While other smaller trials have suggested that peanut immunotherapy may successfully desensitize peanut-allergic individuals, it is not known whether these effects can last without the continued consumption of peanut.  The IMPACT study will help answer this question by assessing participants after they have avoided peanut for 26 weeks following completion of immunotherapy.

Long-term safety and efficacy results of the Edmonton Protocol for islet transplantation were reported October 3, 2015 in the American Journal of Transplantation. Data from the Immune Tolerance Network’s (ITN) EXIIST Study (Extended Immunosuppression in Islet Transplantation), led by Dr. Daniel Brennan (Washington University), demonstrate that islet transplantation with steroid-free immunosuppression over a 10 year period enables good islet graft function and glucose control without serious adverse events or infections.

Jerry Nepom, MD, PhD, director of the Immune Tolerance Network (ITN) and Jonathan Corren, MD, protocol chair for the ITN’s CATNIP Study, were recently interviewed by Tracie Hotchner from the Radio Pet Lady Network.

On August, 31, 2015, interim guidance on the early introduction of peanut for the prevention of peanut allergy based on ITN’s “Learning Early About Peanut Allergy” LEAP Study was published in The Journal of Allergy and Clinical Immunology. The consensus communication was endorsed by the American Academy of Pediatrics and based on consensus among the following organizations: American Academy of Allergy, Asthma & Immunology, American Academy of Pediatrics, American College of Allergy, Asthma & Immunology, Australasian Society of Clinical Immunology and Allergy, Canadian Society of Allergy and Clinical Immunology, European Academy of Allergy and Clinical Immunology, Israel Association of Allergy and Clinical Immunology, Japanese Society for Allergology, Society for Pediatric Dermatology, and World Allergy Organization.

The ITN is currently inviting proposals for novel clinical trials with the aim of inducing tolerance in patients who receive gene/protein-replacement (e.g. hemophilia, Gaucher’s disease) or other exogenous protein therapy, in which the patients are at risk for developing an immune response to the biologic agent. The ideal proposal would have a testable mechanism of tolerance induction and a strategy for assays investigating this mechanism.