Locus, Viatris collaborate on next-gen eye infection therapies

Morrisville-based Locus Biosciences has announced another in a series of research collaborations, this time with Viatris Pharmaceuticals to develop precision-engineered therapies targeting ophthalmic bacterial infections.

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.” 

In other words, Locus is focused on killing bad bugs while protecting and preserving the good ones, like the microbiome in the gut.

Viatris, a global pharmaceutical manufacturer headquartered in the Pittsburgh suburb of Canonsburg, Pennsylvania, already has a major North Carolina distribution center in Greensboro. It also has global centers in Pittsburgh, Shanghai and Hyderabad, India. 

Formed in 2020 from the merger of Mylan and the Pfizer division Upjohn, Viatris has some 32,000 employees in more than 165 countries and territories. Those sites include some 40 manufacturing and 11 R&D facilities.
With this new agreement, Locus will collaborate to develop precision antibacterial therapeutics for serious eye infections, an area of high unmet medical need due to the rise in antibiotic-resistant infections worldwide.

“This partnership with Viatris marks a significant milestone for Locus as we bring our world-leading phage therapy platform to ophthalmology,” said Paul Garofolo, Locus co-founder and CEO. “Targeted therapies are urgently needed to address the growing burden of antimicrobial resistance in eye infections. We’re proud to work with Viatris to accelerate the development of new precision medicines for patients in need.”

Early NCBiotech support

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.

They 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. In that same year, NCBiotech also invested $250,000 into Locus’ open convertible note. 

It was early life-giving and growth-enabling funding. Small, but “oxygen” enough to keep things rolling. Big time.

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 whack infections of other body sites, such as lung infections (pneumonia), intra-abdominal infections and bacteremia (infections of the bloodstream). 

In 2022, Locus completed a $35 million financing, which included a Series B equity financing and conversion of an earlier convertible note. Notable investors participating in the round included Artis Ventures, Viking Global Investors, Johnson and Johnson Innovation – JJDC, Inc. and Discovery Innovations.

BARDA partners on lead candidate

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.

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.

Altogether, Locus has mobilized over $300 million to develop its engineered bacteriophage platform technology and portfolio of five assets targeting important bacterial pathogens in both infectious disease and immunology indications such s Crohn’s disease. These products address serious unmet medical needs that will become even more urgent as antibiotic resistance rates increase worldwide.

“Locus is steadily emerging as one of North Carolina’s standout life sciences success stories,” said Erin Kaltenbrun, Ph.D., director of investments with NCBiotech’s Emerging Company Development team. “Its resilience and ability to consistently capitalize on its programs, even amid challenging market conditions, is both inspiring and instructive for other startups.

“Since receiving early support from NCBiotech, what began as a lean, ambitious team has grown into a company with multiple active partnerships across industry and government, including BARDA, CARB-X, NIH and Viatris. Pretty impressive.”