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Locus Biosciences describes GUARDIAN platform, early E. coli UTI signals and scaling plans

September 21, 2026 | Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS), Executive, Federal


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Locus Biosciences describes GUARDIAN platform, early E. coli UTI signals and scaling plans
Ashley Trama, vice president at Locus Biosciences, described the company's GUARDIAN platform that combines SENTRY wastewater surveillance, SHIELD engineering of payload‑enhanced phage, and on‑site CMC manufacturing to move precision antibacterials into the clinic. She said SENTRY has banked over 8,000 bacterial isolates and about 8,500 bacteriophages and that the robotics platform has analyzed roughly 8.5 million phage–bacteria interactions to train predictive models.

Trama presented interim clinical PK/PD results for an engineered phage program targeting E. coli UTIs. In the dose‑selection portion of the phase II study, she said bacterial titers dropped several logs within days and that at the test‑of‑cure visit (day 10) the trial observed micro cure in 87.5 percent of patients and 100 percent clinical cure among those patients; lower bacterial titers were maintained through day 34. She cautioned that placebo‑controlled, double‑blind results will be reported when the larger randomized portion of the trial completes.

On manufacturing, Trama said Locus built a ~10,000 sq. ft. facility with three suites, has released more than 80 drug‑substance batches and 11 drug‑product batches, and designs processes to scale to roughly 200 liters per phage per cocktail to enable millions of doses. She said FDA feedback on formulations for parenteral, topical, respiratory and oral approaches has been constructive.

Investigator questions focused on biofilm penetration, microbiome sampling, and strains that did not meet microbiological cure. Trama said payloads can help penetrate biofilms in cocktails, that a subset of patients provided stool and other samples for microbiome analysis, and that non‑cleared strains often lacked sensitivity to the phage used. Locus and academic partners plan to unblind and analyze broader datasets as the randomized portion completes.

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