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

ZH9 is very well tolerated with a favourable safety profile, and no dose-limiting toxicities or Grade ≥3 drug-related adverse events reported.ZH9 demonstrates 91% freedom-from-relapse in NMIBC patients who have reached study end.Company plans to run a larger phase 2 study across a range of patient populations spanning intermediate risk and high risk including CIS.

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

About Prokarium

Prokarium is a pioneering clinical-stage biotech company leveraging synthetic biology to create next generation bacterial immunotherapies. This new class of immunotherapy is designed to deliver a broad and durable immune response with the potential to treat a wide range of cancers. The lead program, ZH9, is currently in Phase 1 clinical trials in the US as a monotherapy treatment for NMIBC. Prokarium is based in London, UK. For further information, visit https://www.prokarium.com.

About ZH9

The investigational immunotherapy, ZH9, is being developed as an intravesical treatment for the prevention of recurrence in non-muscle invasive bladder cancer. The PARADIGM-1 study (NCT06181266) has completed enrolment across multiple centers in the United States.

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