LONDON -- Prokarium, a clinical-stage biopharmaceutical company pioneering bacterial immunotherapies for the treatment of solid tumours, announced 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.

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).