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Anaerobic Manufacturing and Molecular Analytical Process Optimization to Support Clinical Development of Live Biotherapeutic Products

厌氧制造和分子分析过程优化支持活生物治疗产品的临床开发

基本信息

批准号：
10561682
负责人：
Ricardo Valladares
金额：
$ 99.32万
依托单位：
SIOLTA THERAPEUTICS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-02-04 至 2025-01-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10561682
关键词：
Acceleration Acute Allergens Allergic Allergic Disease Allergic inflammation Anaerobic Bacteria Anaphylaxis Antioxidants Asthma Atmosphere Atopic Dermatitis Bacteria Biochemical Pathway Biological Markers Biological Response Modifier Therapy Bioreactors Cells Child Childhood Chronic Clinical Clinical Research Clinical Trials Cyclic GMP Data Set Desiccation Development Disease Disease model Dryness Economic Burden Environmental Risk Factor Eosinophilia Evaluation Excipients Extrinsic asthma Feces Flow Cytometry Food Hypersensitivity Formulation Freeze Drying Freezing Goals Healthcare Human Hypersensitivity IgE Immediate hypersensitivity Immune Immune Tolerance Immunologics Impairment Individual Infant Infiltration Interleukin-4 Intervention Lactobacillus Licensing Life Link Lung Lymph Mediating Metagenomics Methods Microbe Molecular Morbidity - disease rate Onset of illness Oral Oral Administration Pharmaceutical Preparations Pharmacologic Substance Phase Phase I Clinical Trials Phase II Clinical Trials Powder dose form Prevention Primary Prevention Probiotics Process Production Public Health Quality of life Reaction Recovery Regulatory T-Lymphocyte Reporting Risk Secondary Prevention Supplementation Symptoms System Temperature Testing Th2 Cells Therapeutic Training United States Food and Drug Administration Update Validation Work allergic airway inflammation analytical method capsule care burden clinical development clinical efficacy clinical material commensal bacteria commercialization comparison control cost design disorder prevention disorder risk global health gut microbiota immunoregulation improved in vivo innovation liquid formulation manufacture member method development microbial mouse model novel novel strategies potency testing pre-clinical prevent process optimization product development programs standard of care success therapeutic candidate

项目摘要

ABSTRACT Allergic diseases including atopic dermatitis, food allergy, and allergic asthma represent a global health problem that disproportionately impacts children. Surprisingly, there are no approved approaches to prevent the development of these diseases in at-risk individuals, resulting in chronic morbidity and economic burden. The management of asthma, for example, carries a steep cost burden of billions of dollars per year in the US alone, of which nearly 20 billion is spent on standard of care treatments with variable efficacy. Food allergy management is generally limited to allergen avoidance and rescue from severe acute anaphylaxis. There is a crucial need to develop innovative strategies to prevent the onset of these Type 1 allergic diseases rather than treating their symptoms. A preventative approach targeting at-risk individuals could significantly reduce the morbidity and healthcare burden associated with these increasingly common conditions. Studies confirm the link between gut microbiota development, immunological training, and allergic disease onset in childhood, and it is now clear that allergic disease risk is associated with aberrant microbial exposures over the first year of life. Longitudinal gut microbiota profiling studies in infants and children show that a loss of specific immunomodulatory commensal bacteria, and their metabolic networks, precedes allergic disease development. Using infant gut microbiota data sets and in vivo allergic disease models, Siolta Therapeutics has designed a live biotherapeutic product (LBP), STMC-103H, to stimulate tolerant immunological development and prevent allergic disease onset in at-risk individuals. STMC-103H contains three distinct active ingredient bacteria isolated from healthy human stool. Siolta has performed extensive cGMP manufacturing development, including formulation, process, and analytical method development, to support Phase 1 and Phase 2 clinical trials of STMC-103H under an IND with the FDA. In this project, we will build on our previous STMC-103H drug product development to improve the stability, potency, and characterization approaches for late-stage clinical trials and subsequent commercialization. Success of this project will directly support the regulatory and commercial development of STMC-103H. Indirectly, this work will improve the manufacturing and clinical development of diverse candidate LBPs containing sensitive live bacteria with high therapeutic potential. Siolta will also seek to license novel manufacturing approaches to other LBP developers.

摘要