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Selective Depletion of Insulin-Specific B cells to Prevent Type 1 Diabetes

选择性消除胰岛素特异性 B 细胞以预防 1 型糖尿病

基本信息

批准号：
9255832
负责人：
TODD C ZION
金额：
$ 99.81万
依托单位：
AKSTON BIOSCIENCES CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-09-15 至 2019-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9255832
关键词：
20 year old Affect American Antibodies Autoantibodies Autoantigens Autoimmune Diseases B cell repertoire B-Lymphocyte Subsets B-Lymphocytes Beta Cell Binding Biological Assay Biological Sciences Blood Blood Cells Blood Chemical Analysis Blood Glucose Cell Line Cells Child Chimeric Proteins Chinese Hamster Ovary Cell Clinical Clone Cells Control Groups Cyclic GMP Data Development Diabetes Mellitus Diagnosis Diet Disease Dose Drug Kinetics Economics Emotional Generations Health Care Costs Human In Vitro Inbred NOD Mice Injection of therapeutic agent Insulin Insulin Antibodies Insulin-Dependent Diabetes Mellitus Lead Manufactured Materials Measurement Medical Mus National Institute of Diabetes and Digestive and Kidney Diseases Newly Diagnosed Non obese Organ Weight Pain Pathogenicity Patients Performance Pharmaceutical Preparations Phase Play Primates Public Health Rattus Research Rest Risk Risk Reduction Rodent Role Safety Sampling Small Business Innovation Research Grant Spleen T-Lymphocyte Teenagers Therapeutic Toxic effect Treatment Protocols Work base cell bank cytotoxicity design diabetic dosage experience glucose monitor glycemic control high risk in vivo islet killings man manufacturing process mouse model nonhuman primate novel peripheral blood prevent psychologic research clinical testing subcutaneous targeted agent therapeutic evaluation treatment duration

项目摘要

PUBLIC DESCRIPTION Akston is developing a subcutaneously administered therapeutic for preventing or delaying the onset of diabetes in pre-diabetic patients who are at high risk (those who display autoantibodies for insulin, GAD65, IA-2, and ZnT8) for developing Type 1 diabetes (T1D). The therapeutic is designed to delete a subset of B-cells that likely play a role in disease development using a patient’s own antibody directed cell cytotoxicity machinery. The work covered in this submission builds on Phase 1 SBIR results obtained from mouse models of T1D. Before entering into the IND stage, however, Akston seeks to develop a clinically-acceptable manufacturing process, evaluate safety in rodent and non-human primates, and confirm the therapeutic performance with human cells obtained from T1D patients. Doing so will provide a critical risk reduction to justify further IND-enabling safety and efficacy work, and, eventually, clinical testing of the therapeutic in man. The impacts to public health as a result of this project are potentially significant. Healthcare costs directly attributable to T1D patients currently account for nearly $15 billion annually. In addition to the 3 million Americans who currently live with T1D, 30,000 new T1D patients are diagnosed each year, with the rate of newly diagnosed patients < 20 years of age increasing by 23% in just the past decade. If successful, Akston’s therapeutic could lead to a significant reduction in health care costs and possibly free pre-T1D children and teenagers from a lifetime of glucose monitoring and insulin injections.

公共描述