Yale University

Provention Bio, Inc.

Benaroya Research Institure at Virginia Mason

Kevan C Herold

Francisco A Leon

Peter S Linsley

Eitan Moshe Akirav

Jay S Skyler

Sarah Alice Long

Provided herein, in one aspect, is a method of preventing or delaying the onset of clinical type 1 diabetes (T1D), comprising: providing a non-diabetic subject who is at risk for T1D; administering a prophylactically effective amount of an anti-CD3 antibody to the non-diabetic subject; and determining, prior to or after the administering step, that the non-diabetic subject has more than about 5% to more than about 10% TIGIT+KLRG1+CD8+ T-cells in all CD3+ T cells, which is indicative of successful prevention or delay of the onset of clinical T1D.

Methods and compositions for preventing type 1 diabetes

Provided herein, in one aspect, is a method of preventing or delaying the onset of clinical type 1 diabetes (T1D), comprising: providing a non-diabetic subject who is at risk for T1D; determining that the non-diabetic subject (1) is substantially free of antibodies against zinc transporter 8 (ZnT8), (2) is HLA-DR4+, and/or (3) is not HLA-DR3+; and administering a prophylactically effective amount of an anti-CD3 antibody to the non-diabetic subject.

The present invention relates to compositions and methods for detecting cell death by detecting cell DNA in a biological sample. The invention relates the discovery that the presence of hypomethylated &#x3b2; cell DNA outside of the pancreas of a subject is indicative of &#x3b2; cell death. Thus, in one embodiment, the invention is a method of detecting hypomethylated &#x3b2; cell insulin DNA in a biological sample of a subject including the steps of: obtaining a biological sample from the subject, where the biological sample is obtained from outside of the subject's pancreas and where the biological sample contains &#x3b2; cell insulin DNA; determining the methylation status of at least one of the CpG dinucleotides in the &#x3b2; cell insulin DNA, where when at least one of the CpG dinucleotides in the &#x3b2; cell insulin DNA is determined to be unmethylated, the hypomethylated &#x3b2; cell insulin DNA is detected.

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Norwalk, CT, United States of America

Kevan C Herold