The PARADIGM-1 trial will enrol patients with non-muscle invasive bladder cancer in the US. Credit: Shidlovski / Shutterstock.

UK-based biopharmaceutical company Prokarium has dosed the first subject in the PARADIGM-1 Phase I/Ib study of ZH9, an investigational bacterial immunotherapy, for patients with non-muscle invasive bladder cancer (NMIBC) in the US.

This development follows the clearance of an investigational new drug (IND) application by the US Food and Drug Administration (FDA) in November last year, allowing the trial commencement.

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The trial is being conducted across multiple US centres.

It aims to assess the safety of a single intravesical dose of ZH9 in NMIBC patients.

The study will also analyse the clinical efficacy of ZH9 in pre-planned expansion cohorts under the same IND.

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This is part of a broader effort to redefine the treatment landscape for NMIBC patients with a single-dose intravesical induction regimen.

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Prokarium CMO Dr Josefin-Beate Holz said: “Dosing our first patient in the clinical trial is an exciting milestone.

“It translates our scientific promises into practical advancements, as we strive to transform the treatment paradigm for patients with NMIBC.”

The company’s Living Cures platform is designed to modernise precision medicine by creating programmable off-the-shelf therapeutics.

This platform could lead to a new class of immunotherapies to provide equitable access.

Following an announcement of its partnership with Ginkgo Bioworks in January 2023, Prokarium secured $30m in new funding in February.

Prokarium CEO Kristen Albright said: “We are grateful to the patients and urologists involved in the PARADIGM-1 clinical trial.

“This achievement represents a pivotal moment for Prokarium as we introduce Living Cures, a novel class of immunotherapies built with synthetic biology.”