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Manufacture of defined live microbial therapeutics for infectious and inflammatory disease

Award Number: R01DK141891
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2025
PERIOD OF PERFORMANCE END DATE: 01/31/2029

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Manufacture of defined live microbial therapeutics for infectious and inflammatory disease - PROJECT SUMMARY The approval of two fecal-based products for the treatment of recurrent Clostridioides difficile infection (rCDI) demonstrates the potential of microbial therapeutics to treat human disease. However, fecal-based products have a poorly defined safety profile that varies by fecal donor. In addition, fecal-based products are inherently not scalable as increasing drug production requires increasing stool donations provided by individual humans. Defined live biotherapeutic products (LBP) comprised of in vitro manufactured bacterial strains provide a scalable alternative to fecal products and ideally contain only the necessary active ingredients (i.e., bacterial strains) that are sufficient for the desired therapeutic benefit. The transition of the microbiome field from fecal products to defined consortium has been slow as the former requires a stool sample, a blending device and a crude filter, while the latter requires knowledge of in vitro manufacturing of anaerobic bacteria on animal-free media at scales sufficient to dose humans. We developed and manufactured the defined LBP MTC01, comprised of the 15 best engrafting bacterial strains isolated from a frequently successful fecal transplant donor. MTC01 is currently being tested in a phase 1b clinical trial comparing this defined consortium with fecal transplant with stool from the donor from which the MTC01 strains were isolated. Building on this successful transition from fecal based products to defined LBPs, we now propose to increase the scale and throughput of defined LBP generation to bringing new bacterial consortia to the clinic while sharing know-how to expand the number of translational studies in the microbiome field. We will develop a solid-state fermentation platform for manufacturing defined LBPs in parallel to decrease manufacturing times from months to weeks (Aim 1). We will develop strain characterization pipelines to estimate the feasibility of manufacturing each strain on animal- free media and to identify safety concerns related antibiotic resistance and the feasibility of standard microbial enumeration assays for non-sterile products (USP61/USP62) that are required for human defined LBPs. We will use these advances to develop multiple drug products for the treatment of UC, and we will seek regulatory feedback through preIND and IND submissions to the FDA (Aim 2). Finally, we will explore genetic engineering strategies to add new functions to stably-colonizing high abundance anaerobes for use in future defined LBPs (Aim 3). Collectively, these studies will advance defined LBP manufacturing technologies and concepts to streamline the generation of live microbial therapeutics, and they will advance multiple defined LBPs manufactured in this proposal through the regulatory steps necessary for at least two additional human trials of defined LBPs in rCDI and ulcerative colitis.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $671,511 )
2026	2026	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	1/19/2026	NON-COMPETING CONTINUATION	$671,511
														Subtotal = $671,511

Issue Date FY: 2025 ( Subtotal = $671,511 )
2025	2025	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	1	5/16/2025	NEW	$87,297
2025	2025	ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI	1 GUSTAVE L LEVY PL	NEW YORK	NY	10029	NEW YORK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	1/21/2025	NEW	$584,214
														Subtotal = $671,511

Grand Total All Awards = $1,343,022

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Manufacture of defined live microbial therapeutics for infectious and inflammatory disease

Award Number: R01DK141891

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/01/2025

PERIOD OF PERFORMANCE END DATE: 01/31/2029

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