Development of Drug Detoxifying Bacteria for Chemotherapy Induced Gut Injury

开发用于化疗引起的肠道损伤的药物解毒细菌

• 批准号: 10560782
• 负责人: MING HU
• 金额: $ 5.5万
• 依托单位: SANARENTERO LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-23 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10560782
• 关键词: Administrative Supplement; Award; Bacteria; Biological Response Modifier Therapy; Biomedical Engineering; Businesses; Cancer Patient; Clinic; Clinical; Colon; Development; Diarrhea; Disseminated Malignant Neoplasm; Dose; Dose-Limiting; Enzymes; Freeze Drying; Glucose; Grant; Hospital Costs; Hospitalization; Incidence; Injury; Innovation Corps; Interview; Intestines; Learning; Life Expectancy; Modeling; Morbidity - disease rate; Patients; Pharmaceutical Preparations; Phase; Plants; Price; Process; Quality of life; Rattus; Recurrent disease; Refractory; Research; SN-38; Safety; Severities; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Solid; Techniques; Technology; Toxic effect; Treatment Cost; United States National Institutes of Health; cancer therapy; capsule; chemotherapy; commercialization; drug development; glycosylation; improved; irinotecan; member; mortality; novel therapeutics; operation; overexpression; prevent; programs; refractory cancer; research and development; side effect; success

PROJECT SUMMARY/ ABSTRACT The overall objective of our predicate STTR Phase I grant (1R41CA261292-01) is to develop a live biotherapeutic product (i.e., a bioengineered bacteria overexpressing a plant enzyme delivered in a protective capsule directly to the colon) for the effective glycosylation of SN-38 to SN-38 glucose for alleviating irinotecan-induced severe delayed-onset diarrhea (SDOD) in the cancer patients. Currently, there is no therapy available to successfully manage the dose-limiting intestinal toxicity (Grade 3 or 4 diarrhea) of irinotecan in about 15% of the patients on standard irinotecan therapy. Moreover, without a solution for effective management of irinotecan-induced SDOD, metastatic refractory cancer patients are unable to maintain the high dose of irinotecan therapy required for their cancer treatment. We believe DDB will allow for better management of SDOD leading to improved quality of life due to reduced severity and incidences of diarrhea, morbidity and mortality due to cessation of chemotherapy, and hospitalization cost. Specific Aims of the predicate phase I STTR application are to 1) develop traceable, safe, and active DDB to detoxify SN-38, 2) develop a colon-optimized capsule delivery of traceable and highly active lyophilized DDBs, and 3) evaluate the safety and efficacy of 2 active DDBs in the irinotecan-induced SDOD rat model. For taking this technology from lab to market faster and successfully, Sanarentero is in the process of developing a viable business model and commercialization strategy including IP portfolio, clinical and regulatory strategies, financing strategies for R&D and business operations, value proposition, product pricing, and strategic partnership with big Pharma. However, we need solid market and customer research in the live biotherpeautics market landscape for developing a realistic path forward. To aid in our efforts in this direction, Sanarentero has put together a 3-member team to participate in the I-Corps at NIH program aims at equipping the SBIR/STTR phase I awardees in the customer discovery research. At the end of this program, we hope to gather sufficient critical learning from conducting customer and stakeholders interviews that will allow us to realign/redefine our current business model and commercialization strategies for maximizing the market success of our DDB.

项目摘要/摘要