Business Wire

PROKARIUM

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

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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240207504370/en/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

From Pilots to Profit: NTT DATA's 2026 Global AI Report Shows How Top Performers Turn AI Vision Into Value8.12.2025 14:00:00 CET | Press release

Study reveals how the top 15% of companies are 2.5x more likely to post >10% revenue growth and over 3x more likely to achieve ≥15% profit margins from AI deployments NTT DATA, a global leader in AI, digital business and IT services, today released the 2026 Global AI Report: A playbook for AI leaders. The playbook is based on the company’s new benchmark research and reveals how “AI leaders” are separating from competitors through strategy and execution. The analysis is based on a survey of 2,567 senior executives across 35 countries and 15 industries. Only 15% of participating organizations qualified as “AI leaders,” defined by clear AI strategies, mature operating models and focused execution. These leaders report significantly higher revenue growth and profit margins than other organizations. “AI accountability now belongs in the boardroom and demands an enterprise-wide agenda,” said Yutaka Sasaki, President and CEO, NTT DATA Group. “Our research shows that a small group of AI leader

AdvanCell Receives First Delivery of High-Activity Thorium-228, Highlighting a Unique Industry Capability and Expertise Essential to Scaling Lead-212 Production for Targeted Alpha Therapies8.12.2025 14:00:00 CET | Press release

Thorium-228 (228Th) is the parent isotope and key starting material to produce the alpha-emitter Lead-212 (212Pb) The established capability to receive and process high-activity 228Th, provides a key competitive advantage in scaling up 212Pb production to support the rapid advancement of 212Pb-ADVC001 (ADVC001) clinical development and the expanding pipeline The received 228Th will be processed into sources for our proprietary generator and installed in production systems first in Australia and subsequently in the US, as part of the planned expansion AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, today announced it has received the first delivery of high-activity 228Th, the parent isotope of 212Pb and a key starting material to produce the alpha-emitter 212Pb, used to manufacture ADVC001, the company’s lead asset, and other 212Pb-based radioligand therapies in the pipeline. This delivery marks a major milestone for the

BRUKINSA Delivers Landmark 74% 6-Year PFS in Patients with Treatment-Naïve Chronic Lymphocytic Leukemia8.12.2025 14:00:00 CET | Press release

Multiple long-term follow-up studies confirm BRUKINSA’s superior efficacy and favorable tolerability versus ibrutinib in relapsed or refractory CLLAdditional ASH data from investigational BTK degrader, BGB-16673, highlight potential first- and best-in-class activity with durable responses in heavily pretreated patients with CLL BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reaffirms its position as the leader in chronic lymphocytic leukemia (CLL) innovation by showcasing the depth, quality, and momentum of its hematology portfolio at the 67th ASH Annual Meeting and Exposition in Orlando, Florida. The totality of BeOne’s ASH data reinforce BRUKINSA® (zanubrutinib) as the foundational Bruton’s tyrosine kinase inhibitor (BTKi) of choice. “At ASH 2025, we will present new data from across our CLL franchise, highlighting both the strength of BRUKINSA and the potential of BGB-16673,” said Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology,

Pink Changing Lives®: Mary Kay Builds 11th Preschool in Sri Lanka, Turning a Dream Into Thousands of New Beginnings8.12.2025 14:00:00 CET | Press release

Each year, Mary Kay supports causes that enrich millions of women’s lives globally, including access to education Mary Kay Inc., a global champion for women’s empowerment, is turning pink into purpose through its Pink Changing Lives® Program to raise awareness and funds to support life-changing programs advancing cancer research, support survivors of domestic violence, protect our planet’s most precious resources, and create opportunities that help women and their families thrive. Since 1996, the multi-faceted Pink Changing Lives® Program has donated over $230 million in monetary and in-kind donations to improve the lives of women and their families in communities around the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251208554750/en/ Mary Kay Inc., a global champion for women’s empowerment, is turning pink into purpose through its Pink Changing Lives® Program to raise awareness and funds to support life-changing p

IonQ Expands in EU With Slovakia’s First National Quantum Communication Network8.12.2025 13:05:00 CET | Press release

Partnering with the Slovak Academy of Sciences, IonQ bolsters national security and European quantum communications infrastructure IonQ (NYSE: IONQ), the world’s leading quantum company, through its subsidiary ID Quantique (IDQ), today announced the deployment of Slovakia’s first national quantum communication network. Developed in partnership with the Institute of Physics, Slovak Academy of Sciences (IPSAS), the new system features a resilient hybrid architecture designed to strengthen the country’s cybersecurity infrastructure and support Europe’s quantum digital programs. The Slovak Quantum Communication Infrastructure (skQCI) project represents a major milestone in Slovakia’s contribution to the European Quantum Communication Infrastructure (EuroQCI) initiative, which seeks to establish a secure quantum-resistant communication backbone covering all European Union (EU) member states and territories. By integrating quantum-safe technologies at a national scale, Slovakia will directly

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye