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A Yeast-based Immunotherapy against Clostridioides difficile infection

Award Number: R44AI155277
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2020
PERIOD OF PERFORMANCE END DATE: 10/31/2024

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A Yeast-based Immunotherapy against Clostridioides difficile infection - Abstract Antibiotic-resistant Clostridioides difficile is responsible for more than 29,000 deaths in the US each year and the infection is an urgent threat (as designated by CDC) to public health. The incidence of C. difficile infection (CDI) and disease severity is increasing in recent years due to the emergence of hypervirulent and antibiotic- resistant strains. CDI is caused by the exotoxins TcdA and TcdB secreted by C. difficile in the colon of the host. Current standard treatment with antibiotics is not optimal and is accompanied by a high recurrence rate due to the disruption of host colonization resistance. Moreover, there is no approved prevention against the infection. Our goal is to develop a novel yeast-based immunoprophylactic/therapeutic against both primary and recurrent CDI. We have developed a therapeutic lead by engineering a probiotic yeast, Saccharomyces boulardii (Sb), to secrete an antitoxin ABAB (Sb-ABAB). ABAB is a fusion protein of 4 VHHs targeting 2 distinct neutralizing epitopes in TcdA and 2 in TcdB respectively. ABAB is ultrapotent in neutralizing both TcdA and TcdB and broadly active against toxins from 64 clinical isolates. Our preliminary data showed that oral Sb- ABAB protected mice from both primary and recurrent CDI. The objectives of this Fast-track SBIR are to: 1) phenotypically and genetically characterize Sb-ABAB to ensure its identity and quality; 2) determine pharmacokinetic and safety profiles of Sb-ABAB; 3) develop clinic-compatible formula of Sb-ABAB capsules; and 4) perform IND-enabling efficacy study in a piglet model of CDI. All proposed activities will be guided by an exceptional advisory/consultant team with specialized expertise in business development, biologics regulation, product development and planning, and clinical development. Upon the completion of the proposed studies, we will pursue Phase IIb for GMP manufacturing of Sb-ABAB, GLP toxicology and IND submission in the future.


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: 2025 ( Subtotal = $0 )
2025	2023	FZATA INC	1450 S ROLLING RD	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	4	4/16/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	4	2/16/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $906,503 )
2023	2023	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	001	4	9/13/2023	NON-COMPETING CONTINUATION	$0
2023	2023	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	4	10/24/2022	NON-COMPETING CONTINUATION	$906,503
														Subtotal = $906,503

Issue Date FY: 2022 ( Subtotal = $932,749 )
2022	2022	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	001	3	9/26/2022	NON-COMPETING CONTINUATION	$0
2022	2022	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	3	11/5/2021	NON-COMPETING CONTINUATION	$932,749
														Subtotal = $932,749

Issue Date FY: 2021 ( Subtotal = $554,355 )
2021	2021	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	001	2	4/23/2021	EXTENSION WITH OR WITHOUT FUNDS	$16,732
2021	2021	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	2	3/30/2021	EXTENSION WITH OR WITHOUT FUNDS	$537,623
2021	2021	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	003	2	9/27/2021	EXTENSION WITH OR WITHOUT FUNDS	$0
2021	2020	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	002	1	9/15/2021	NEW	$0
														Subtotal = $554,355

Issue Date FY: 2020 ( Subtotal = $169,461 )
2020	2020	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	001	1	7/21/2020	NEW	$0
2020	2020	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	1	7/20/2020	NEW	$169,461
														Subtotal = $169,461

Grand Total All Awards = $2,563,068

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A Yeast-based Immunotherapy against Clostridioides difficile infection

Award Number: R44AI155277

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/01/2020

PERIOD OF PERFORMANCE END DATE: 10/31/2024

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