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.