Tuesday, August 19, 2025 8/19/2025

Optimization, Manufacturing and Testing of a Lead Therapeutic Bacteriophage Cocktail for the Treatment of Antibiotic-Resistant Klebsiella pneumoniae Infections

Award Number: R01AI176546
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: 07/21/2023
PERIOD OF PERFORMANCE END DATE: 06/30/2028

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Optimization, Manufacturing and Testing of a Lead Therapeutic Bacteriophage Cocktail for the Treatment of Antibiotic-Resistant Klebsiella pneumoniae Infections - PROJECT SUMMARY/ABSTRACT Infections caused by Klebsiella pneumoniae are increasingly prevalent and difficult to treat due to ineffective treatment options due to increased antibiotic resistance. Bacteriophages, viruses that infect and kill bacteria, are being used to effectively treat and cure infections caused by a number of bacterial pathogens. To address the need for new treatments for wound and pulmonary infections caused by K. pneumoniae, our group has developed a 5-phage lead candidate therapeutic cocktail that is capable of infecting 53 of our 100-strain test panel. The goal of this proposal is to optimize our lead therapeutic and its production as well as to conduct the required pre-Investigational New Drug (IND) testing and benchmarking necessary for the successful submission and review of an IND application for a phase 1 clinical trial. The proposed work will be conducted through a partnership between the J. Craig Venter Institute (JCVI), the Walter Reed Army Institute of Research (WRAIR) and Adaptive Phage Therapeutics (APT). It will leverage JCVI’s history of synthetic and phage genomics, WRAIR’s experience developing phage therapeutics, development of mouse models, and APTs cGMP production capabilities and experience with phage clinical trials. The goal to prepare our lead candidate therapeutic for IND submission to FDA will materialize through three main objectives: 1) To optimize the lead therapeutic, 2) To conduct IND-required testing, and 3) To optimize and scale-up for cGMP manufacturing and testing. The workflow to achieve these objectives is innovative, utilizing cutting-edge technologies, and encompasses the entire process from optimization and testing to GMP production of the therapeutic. More significantly, it will be a platform for developing future phage-based therapeutics for other important bacterial pathogens.


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 = $1,068,054 )
2025	2025	J. CRAIG VENTER INSTITUTE, INC.	4120 CAPRICORN LN	LA JOLLA	CA	92037	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	3	8/1/2025	NON-COMPETING CONTINUATION	$1,068,054
														Subtotal = $1,068,054

Issue Date FY: 2024 ( Subtotal = $918,873 )
2024	2024	J. CRAIG VENTER INSTITUTE, INC.	4120 CAPRICORN LN	LA JOLLA	CA	92037	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	2	6/20/2024	NON-COMPETING CONTINUATION	$918,873
														Subtotal = $918,873

Issue Date FY: 2023 ( Subtotal = $921,333 )
2023	2023	J. CRAIG VENTER INSTITUTE, INC.	4120 CAPRICORN LN	LA JOLLA	CA	92037	SAN DIEGO	USA	Allergy and Infectious Diseases Research	000	1	7/21/2023	NEW	$921,333
														Subtotal = $921,333

Grand Total All Awards = $2,908,260

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Optimization, Manufacturing and Testing of a Lead Therapeutic Bacteriophage Cocktail for the Treatment of Antibiotic-Resistant Klebsiella pneumoniae Infections

Award Number: R01AI176546

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: 07/21/2023

PERIOD OF PERFORMANCE END DATE: 06/30/2028

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