# Development of Drug Detoxifying Bacteria for Chemotherapy Induced Gut Injury

> **NIH NIH R41** · SANARENTERO LLC · 2022 · $55,000

## Abstract

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.

## Key facts

- **NIH application ID:** 10560782
- **Project number:** 3R41CA261292-01S1
- **Recipient organization:** SANARENTERO LLC
- **Principal Investigator:** MING HU
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $55,000
- **Award type:** 3
- **Project period:** 2021-09-23 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10560782

## Citation

> US National Institutes of Health, RePORTER application 10560782, Development of Drug Detoxifying Bacteria for Chemotherapy Induced Gut Injury (3R41CA261292-01S1). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10560782. Licensed CC0.

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