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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.

Individuals with new-onset type 1 diabetes who took two courses of alefacept (Amevive®, Astellas Pharma Inc.) soon after diagnosis show preserved beta cell function after two years compared to those who received a placebo. The positive results of the Immune Tolerance Network’s (ITN) T1DAL study [Inducing Remission in New Onset T1DM with Alefacept (Amevive®)], led by Mark Rigby, MD, PhD, of Indiana University were published today in the Journal of Clinical Investigation.

The results of the Immune Tolerance Network’s (ITN) “Learning Early About Peanut” (LEAP) study published today in the New England Journal of Medicine demonstrate that consumption of a peanut-containing snack by infants who are at high-risk for developing peanut allergy prevents the subsequent development of allergy. The LEAP study, designed and conducted by the ITN with additional support from FARE and led by Professor Gideon Lack at Kings College London, is the first randomized trial to prevent food allergy in a large cohort of high-risk infants.

On Monday the ITN opened a new pilot study to compare two different methods for assessing allergic responses: environmental exposure chambers and nasal allergen challenges. The CAT EEC study, “Cat Pilot Study – Environmental Exposure Chamber (EEC) vs. Nasal Allergen Challenge (NAC),” is being conducted at Inflamax Research, Inc. in Ontario, Canada and led by Drs. Stephen Durham (Imperial College London) and Piyush Patel (Inflamax Research, Inc.).

A new ITN type 1 diabetes trial opened today at the first site, Sanford Health in Sioux Falls, SD. The EXTEND trial (Preserving Beta-Cell Function with Tocilizumab in New Onset Type 1 Diabetes) will test whether tocilizumab (ACTEMRA®; Genentech), an antibody that targets the interleukin-6 (IL-6) receptor, can slow disease progression and help maintain natural insulin production in adults with new-onset type 1 diabetes.

The ITN has an interest in antigen-specific T cell tolerance in multiple sclerosis, an autoimmune disease in which autoreactive T cells specific for myelin-associated antigens are thought to play a role in pathogenesis. Assessment of antigen-specific tolerance in multiple sclerosis will require reliable assays to detect and phenotype T cell responses to myelin-associated antigens in a clinical trial setting. To this end, the ITN is seeking assays for assessing functional tolerance and biomarkers of tolerance in antigen-specific CD4 and CD8 effector and regulatory T cells.  

An article in Seattle Magazine about the landscape for immunotherapy in Seattle gives a nice mention of the Benaroya Research Institute and the Immune Tolerance Network:

“Immunotherapy is being applied to a multitude of diseases, such as leukemia, melanoma, lupus and Graves’ disease. At the Benaroya Research Institute (BRI) at Virginia Mason, scientists are using immunotherapy to target type 1 diabetes, multiple sclerosis and rheumatoid arthritis. Dr. Gerald Nepom started the immunology program at BRI in 1985, and this year, the National Institutes of Health asked him to lead the Immune Tolerance Network, a global effort across 250 research sites to develop ways to “reprogram” the immune system, preventing the immune responses that lead to diseases such as asthma and diabetes while still maintaining the body’s ability to fight infection. For the next seven years, the network will be headquartered at BRI, which will receive $27 million annually in support funding. ‘[Immunotherapy] is becoming big science,’ says Homer Lane, executive director at BRI. ‘It needs a lot of people to work together.’”

Washington, DC - Three-year outcomes from an ongoing clinical trial suggest that high-dose immunosuppressive therapy followed by transplantation of a person's own blood-forming stem cells may induce sustained remission in some people with relapsing-remitting multiple sclerosis (RRMS). RRMS is the most common form of MS, a progressive autoimmune disease in which the immune system attacks the brain and spinal cord. The trial is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and conducted by the NIAID-funded Immune Tolerance Network (ITN).

Last Friday the Immune Tolerance Network (ITN) opened a new combination therapy study in lupus nephritis, CALIBRATE, at University of California, San Francisco (UCSF). The CALIBRATE Study will be led by Drs. Betty Diamond (North Shore Feinstein Institute), David Wofsy (UCSF), Cynthia Aranow (North Shore Feinstein Institute), and Maria Dall’Era (UCSF), and will test a novel regimen of rituximab (Rituxan, Genentech, Inc.) followed by belimumab (BENLYSTA®, GlaxoSmithKline) in patients with refractory lupus nephritis.

The results of the ACCESS study, “Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis” sponsored by the Immune Tolerance Network (ITN) and led by Drs. Betty Diamond (The Feinstein Institute) and David Wofsy (University of California, San Francisco), were published this week in Arthritis and Rheumatology.  Abatacept (ORENCIA®) in combination with low-dose cyclophosphamide (Cytoxan, Bristol-Myers Squibb) did not improve the proportion of lupus nephritis patients who achieved a complete response compared to low-dose cyclophosphamide alone.