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A Novel Humanized Tetra-specific Antibody against Clostridium difficile Infection

Award Number: R01AI132207
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: 06/01/2017
PERIOD OF PERFORMANCE END DATE: 05/31/2024

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A Novel Humanized Tetra-specific Antibody against Clostridium difficile Infection - Abstract Antibacterial resistance is a global public health crisis. Antibiotic-resistant Clostridium difficile is responsible for more than 29,000 deaths in the US each year and the infection represents an urgent threat to public health worldwide. Of most concern is that the incidence of C. difficile infection (CDI) and disease severity is rapidly increasing in recent years due to the emergence of hypervirulent and antibiotic-resistant strains. CDI is caused by two major toxins TcdA and TcdB, absent which the bacterium is avirulent. Current standard treatment with antibiotics is sub-optimal and accompanied by a high recurrence rate due to the disruption of gut microbiota. Approaches using antibodies to target the major virulence factors represent a new treatment option against CDI. However, the most advanced therapeutic antibody bezlotoxumab, an anti-TcdB monoclonal antibody from Merck, only showed a comparable effect as antibiotic fidaxomicin on reducing CDI recurrence in recent Phase III trials. This less-than-desirable efficacy is likely due to targeting a single epitope of the toxin and low potency of the antibody. We have developed a novel tetra-specific, humanized antibody FZ001 based on 4 VHHs targeting distinct epitopes, two on each of the toxins. FZ001 potently and broadly neutralizes both toxins from different clinical isolates and demonstrates a potent therapeutic efficacy against both primary and recurrent CDI in mice. cGMP-grade CHO lines have been constructed with a high expression level of FZ001. In response to RFA-AI-16-034, we propose to develop cell culture parameters and analytic assays and subsequent manufacturing process in order to generate FZ001 for GLP toxicology. This project will allow the generation of the critical data of chemical, manufacturing, and control (CMC) for future IND filing and Phase I clinical trials.


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 = -$212,291 )
2025	2022	FZATA INC	1450 S ROLLING RD	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	6	10/1/2024	NON-COMPETING CONTINUATION	-$212,291
2025	2022	FZATA INC	1450 S ROLLING RD	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	001	6	1/22/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = -$212,291

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	6	6/26/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $1,008,708 )
2022	2022	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	6	6/2/2022	NON-COMPETING CONTINUATION	$1,008,708
														Subtotal = $1,008,708

Issue Date FY: 2021 ( Subtotal = $167,253 )
2021	2021	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	5	6/16/2021	NON-COMPETING CONTINUATION	$167,253
														Subtotal = $167,253

Issue Date FY: 2020 ( Subtotal = $2,535,343 )
2020	2020	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	003	4	8/11/2020	NON-COMPETING CONTINUATION	$2,154,339
2020	2019	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	002	3	7/29/2020	NON-COMPETING CONTINUATION	$229,186
2020	2018	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	001	2	7/29/2020	NON-COMPETING CONTINUATION	$79,403
2020	2017	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	1	7/29/2020	NEW	$72,415
														Subtotal = $2,535,343

Issue Date FY: 2019 ( Subtotal = $1,909,432 )
2019	2019	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	001	3	6/3/2019	NON-COMPETING CONTINUATION	$1,909,432
2019	2018	FZATA INC	1448 S ROLLING RD STE 120	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	2	3/1/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,909,432

Issue Date FY: 2018 ( Subtotal = $1,091,557 )
2018	2018	FZATA INC	1448 S ROLLING RD STE 120	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	2	5/31/2018	NON-COMPETING CONTINUATION	$1,091,557
														Subtotal = $1,091,557

Issue Date FY: 2017 ( Subtotal = $1,388,211 )
2017	2017	FZATA INC	1448 S ROLLING RD STE 120	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	001	1	6/8/2017	NEW	$0
2017	2017	FZATA INC	1448 S ROLLING RD STE 120	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	1	5/29/2017	NEW	$1,388,211
														Subtotal = $1,388,211

Grand Total All Awards = $7,888,213

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A Novel Humanized Tetra-specific Antibody against Clostridium difficile Infection

Award Number: R01AI132207

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: 06/01/2017

PERIOD OF PERFORMANCE END DATE: 05/31/2024

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