R01AI176546
Project Grant
Overview
Grant Description
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 APT's 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.
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 APT's 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.
Awardee
Funding Goals
NOT APPLICABLE
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Rockville,
Maryland
208506556
United States
Geographic Scope
Single Zip Code
Related Opportunity
Analysis Notes
Amendment Since initial award the total obligations have increased 409% from $921,333 to $4,693,286.
J. Craig Venter Institute was awarded
Optimizing Bacteriophage Cocktail for K. pneumoniae Treatment
Project Grant R01AI176546
worth $4,693,286
from the National Institute of Allergy and Infectious Diseases in July 2023 with work to be completed primarily in Rockville Maryland United States.
The grant
has a duration of 5 years and
was awarded through assistance program 93.855 Allergy and Infectious Diseases Research.
The Project Grant was awarded through grant opportunity Partnerships for the Development of Novel Therapeutics to Combat Select Antibiotic Resistant Bacteria and Fungi (R01 Clinical Trial Not Allowed).
Status
(Ongoing)
Last Modified 7/6/26
Period of Performance
7/21/23
Start Date
6/30/28
End Date
Funding Split
$4.7M
Federal Obligation
$0.0
Non-Federal Obligation
$4.7M
Total Obligated
Activity Timeline
Subgrant Awards
Disclosed subgrants for R01AI176546
Transaction History
Modifications to R01AI176546
Additional Detail
Award ID FAIN
R01AI176546
SAI Number
R01AI176546-509992768
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Nonprofit With 501(c)(3) IRS Status (Other Than An Institution Of Higher Education)
Awarding Office
75NM00 NIH National Institute of Allergy and Infectious Diseases
Funding Office
75NM00 NIH National Institute of Allergy and Infectious Diseases
Awardee UEI
FL8UNYTG72D1
Awardee CAGE
3YFD9
Performance District
MD-08
Senators
Benjamin Cardin
Chris Van Hollen
Chris Van Hollen
Budget Funding
| Federal Account | Budget Subfunction | Object Class | Total | Percentage |
|---|---|---|---|---|
| National Institute of Allergy and Infectious Diseases, National Institutes of Health, Health and Human Services (075-0885) | Health research and training | Grants, subsidies, and contributions (41.0) | $921,333 | 100% |
Modified: 7/6/26