Locus Biosciences awarded $3.3M from NIH for clinical trial

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded Morrisville-based Locus Biosciences $3.3 million, part of a contract that could total up to $28 million if all project milestones are met. Locus logo

The awarded contract will support a proof-of-concept clinical trial of LBP-PA01, Locus’ AI-designed bacteriophage therapeutic for hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) caused by antibiotic-resistant Pseudomonas aeruginosa bacteria.

In 2025, Locus announced a series of research collaborations, one with Viatris Pharmaceuticals to develop precision-engineered therapies targeting ophthalmic bacterial infections.

Research collaborations abound

In January 2019, Locus entered a collaboration with Janssen Pharmaceuticals, one of Johnson & Johnson's companies, to develop, manufacture, and commercialize engineered bacteriophage products from Locus targeting two key bacterial pathogens infecting the respiratory tract and other organ systems. 

Also in 2020, Locus signed a contract with the global nonprofit CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) to fund up to $12.5 million of a $14.8 million program to develop Locus’s LBP-KP01, a CRISPR Cas3-enhanced bacteriophage product targeting the bacterial pathogen Klebsiella pneumoniae (K. pneumoniae). 

The initial target indication was complicated urinary tract infections (cUTIs), but the long-term plan will also be to develop the product to address infections of other body sites, such as the lung (pneumonia), intra-abdominal and bacteremia (bloodstream). 

In 2020, Locus signed a partnership agreement with the Biomedical Advanced Research and Development Authority (BARDA) to co-fund the development of what is now Locus’s lead product candidate, LBP-EC01, also a CRISPR Cas3-enhanced bacteriophage therapy targeting recurrent UTIs (rUTIs) caused by antibiotic-resistant strains of E. coli.

Locus CEO Paul Garofolo
Locus Biosciences CEO Paul Garofolo.

BARDA, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, agreed to provide up to $77 million in funding to Locus as part of a $144 million program to support Phase 2 and Phase 3 clinical trials and other activities required to seek marketing approval from the U.S. Food and Drug Administration for LBP-EC01.

“Partnering with HHS to advance multiple programs under NIAID and BARDA is an exciting evolution for Locus as we deploy our platform to deliver precision antibacterial therapies across diverse indications and routes of administration,” said Paul Garofolo, CEO of Locus Biosciences. “With NIAID driving innovation targeting respiratory infections and BARDA advancing solutions for urinary tract infections, we are united under a shared mission to solve the global antimicrobial resistance crisis. This collaboration underscores the power of Locus’s AI-enabled drug development platform and its advanced U.S.-based manufacturing to accelerate a new generation of engineered bacteriophage therapeutics.”

Early NCBiotech support

Locus, a 2015 spinout of North Carolina State University, has a proprietary development platform that “integrates predictive artificial intelligence (AI), high-throughput robotics, and synthetic biology to create therapeutic cocktails using naturally occurring bacteriophage viruses enhanced with payloads that enhance their ability to selectively eliminate pathogenic bacteria while sparing beneficial species.” 

Locus said the collaboration underscores the growing global recognition of phage therapy as a promising alternative or complement to traditional antibiotics, especially as antimicrobial resistance continues to rise amid decades of chronic under-investment in novel antibacterial treatment approaches.

The North Carolina Biotechnology Center (NCBiotech) played a major role in the birth and early growth of Locus. NCBiotech awarded over $300,000 in grants to university research labs of three of the four Locus scientific founders, who subsequently founded Locus with the help of a 2015 $75,000 NCBiotech Company Inception Loan. 

NCBiotech followed that with a $250,000 Small Business Research Loan a year later, and a $250,000 Strategic Growth Loan in 2017. The company has repaid the NCBiotech loans. In that same year, NCBiotech also invested $250,000 into Locus’ open convertible note. 

Chris Capot, NCBiotech Writer
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