Prokarium Achieves Milestone with First Patient Dosing in PARADIGM-1 Non-Muscle Invasive Bladder Cancer Clinical Trial

LONDON--(BUSINESS WIRE)--Prokarium, a clinical-stage biopharmaceutical company bioengineering Living Cures through cutting-edge synthetic biology, today announces the dosing of the first patient in their PARADIGM-1 Phase I/Ib clinical trial in non-muscle invasive bladder cancer (NMIBC) patients (NCT06181266).

The study is being conducted at multiple clinical sites across the United States and will initially evaluate the safety of a single intravesical administration of their investigational immunotherapy, ZH9, in NMIBC patients. The study will further investigate and characterize clinical efficacy of the ZH9 treatment regimen in pre-planned expansion cohorts under the same IND.

“Dosing our first patient in the clinical trial is an exciting milestone,” said Dr. Josefin-Beate (Josi) Holz, CMO of Prokarium. “It translates our scientific promises into practical advancements, as we strive to transform the treatment paradigm for patients with NMIBC.”

Dr. Daniel Zainfeld, Urology San Antonio, commented, “We are excited to have dosed our first patient in Prokarium’s PARADIGM-1 study. The trial provides us the opportunity to explore an innovative treatment approach for our NMIBC patients who are facing significant gaps in available effective treatment options.”

Kristen Albright, CEO of Prokarium, remarked, "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.”

About Prokarium

Prokarium is a clinical-stage biopharmaceutical company bioengineering Living Cures through cutting-edge synthetic biology. Prokarium’s lead program, currently advancing in US clinical trials for bladder cancer, is a single-dose therapy redesigning the treatment paradigm for patients. The Company’s Living Cures platform aims to transform precision medicine into off-the-shelf programmable therapeutics, promising a new class of immunotherapies with a goal of equitable access. Prokarium is based in London, UK. For further information, visit https://www.prokarium.com.

About ZH9

ZH9, a proprietary bacterial immunotherapy under investigation in the PARADIGM-1 clinical trial (NCT06181266) in the United States, seeks to redesign the treatment paradigm for non-muscle invasive bladder cancer patients through a single-dose intravesical induction regimen.