Prokarium Ltd.

Prokarium’s ZH9 is currently being developed as an intravesical treatment for preventing recurrences in non-muscle invasive bladder cancer. Credit: Aria sandi hasim/Shutterstock. UK-based biopharmaceutical company Prokarium has received two Notices of Allowance from the US Patent and Trademark Office (USPTO). The patents will aid in “strengthening its [the company’s] position in the bladder cancer field”. Application no 17/752,707 pertains to the co-administration of Prokarium’s salmonella strains with immune checkpoint inhibitors, aimed at augmenting the therapeutic efficiency of these inhibitors. Meanwhile, application no 18/559,543 encompasses a salmonella-based method for treating neoplastic diseases, which works by inducing an immune response coupled with targeted anti-tumour action. Prokarium CEO Kristen Albright stated: “This patent bolsters our IP portfolio and, more importantly, creates a stronger foundation for our clinical programme in bladder cancer. “Together, these innovations represent a major value driver for the company, strengthening our position to attract strategic partners and investors as we address large, underserved markets in cancer immunotherapy.” Prokarium’s investigational immunotherapy ZH9 is currently being developed as an intravesical treatment for preventing recurrences in non-muscle invasive bladder cancer. The asset is being analysed in the PARADIGM-1 study, which is actively enrolling patients across multiple centres in the US. In November 2023, the US Food and Drug Administration (FDA) granted clearance for the company’s investigational new drug (IND) application for the trial of ZH9. In March 2024, Prokarium was awarded a UK Research and Innovation (UKRI) engineering biology grant, funded through the UKRI’s Technology Missions Fund and delivered by Innovate UK. This grant is intended to expedite the development of the company’s Living Cures platform, which aims to transform precision medicine through off-the-shelf programmable therapeutics. Leveraging the UKRI engineering biology grant, Prokarium also plans to commence the next phase of development to strengthen its position in the synthetic biology field.

LONDON--( BUSINESS WIRE )--Prokarium, a biopharmaceutical company developing innovative cancer treatments, today announced the receipt of two Notices of Allowance from the United States Patent and Trademark Office (USPTO). These patents, covering applications Nos. 17/752,707 and 18/559,543, strengthen Prokarium’s mission to develop innovative, scalable therapies that address critical gaps in cancer treatment. Application No. 17/752,707 protects the co-administration of Prokarium’s proprietary Salmonella strains with immune checkpoint inhibitors to enhance the checkpoint inhibitors therapeutic efficacy. “This patent, alongside our granted patent in combination with cell therapies, is a significant step toward scaling our technology’s potential in the oncology space," said Dr. Livija Deban, CSO at Prokarium. "By advancing our technology to amplify the effects of immune checkpoint inhibitors, we’re demonstrating a value proposition that investors and partners can rely on as we work towards scalable, impactful cancer treatments." Application No. 18/559,543 protects an advanced Salmonella-based method for treating neoplastic diseases by promoting a robust immune response along with targeted anti-tumor action. “This patent bolsters our IP portfolio and, more importantly, creates a stronger foundation for our clinical program in bladder cancer,” said Kristen Albright, PharmD, Chief Executive Officer at Prokarium. “Together, these innovations represent a major value driver for the company, strengthening our position to attract strategic partners and investors as we address large, underserved markets in cancer immunotherapy.” About Prokarium Prokarium is a biopharmaceutical company transforming the treatment landscape to prevent bladder cancer recurrence. The Company's lead program, currently in U.S. clinical trials as the PARADIGM-1 trial, is designed to achieve relapse-free outcomes, reduce treatment burden, and meet global demand through scalable manufacturing. Prokarium’s Living Cures platform transforms precision medicine into off-the-shelf, programmable therapeutics, offering a new class of immunotherapies that are accessible, customizable, and highly effective. Prokarium is based in London, UK. For further information, visit www.prokarium.com . About ZH9 The investigational immunotherapy ZH9 is being developed as an intravesical treatment for the prevention of recurrences in non-muscle invasive bladder cancer. The PARADIGM-1 study (NCT06181266) is enrolling patients across multiple centers in the United States.

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 . 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.