Prokarium Reports Positive Interim Data from Phase 1/1b PARADIGM-1 trial of ZH9 in NMIBC patients, Demonstrating Excellent Safety and Encouraging Early Efficacy

On May 18, 2026 Prokarium, a clinical-stage biopharmaceutical company pioneering bacterial immunotherapies for the treatment of solid tumours, reported safety and antitumour efficacy results from an interim review of the ongoing Phase 1/1b PARADIGM-1 trial of ZH9 in non-muscle invasive bladder cancer (NMIBC) patients. These data were shared via an oral podium presentation at the American Urology Association (AUA26) Annual Meeting.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Prokarium CMO, Dr Josefin-Beate Holz said "These data demonstrate ZH9 as a universally applicable treatment for patients. As the treatment is very well tolerated and is showing impactful outcomes for early and BCG-non-responsive patients alike, it opens up the potential for ZH9 to be a transformative bladder saving treatment."

"There is a clear and urgent need to move beyond BCG. The current treatment burden—requiring up to 18 catheterisations in the first year— detrimentally impacts real-world compliance and patient outcomes," said Ibs Mahmood, CEO of Prokarium. "Patients deserve a therapy that is not only effective and safe, but also more convenient, and we believe ZH9, reducing this to just 4–5 administrations per year, could be a game changer."

Interim data:

Prokarium’s PARADIGM-1 trial (NCT06181266) is a Phase 1/1b study evaluating safety, tolerability and early efficacy of ZH9 in recurrent intermediate-risk and high-risk NMIBC patients.

Of 22 patients that received at least 1 dose of ZH9, 6 patients (27%) experienced an Adverse Event related to treatment with ZH9 all of which were mild or moderate and transient.
No grade 3 or higher toxicities, dose-limiting toxicities, or drug related serious adverse events were observed.
ZH9 demonstrated 91% freedom-from-relapse at 12 months in the heavily pretreated study population (10/11 patients at 12m, per protocol completion).

(Press release, Prokarium, MAY 18, 2026, View Source [SID1234665843])