Business Wire

PROKARIUM

7.2.2024 13:01:36 CET | Business Wire | Press release

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

Incyte Announces Positive CHMP Opinion for Zynyz® (retifanlimab) for First-Line Treatment of Advanced Squamous Cell Carcinoma of the Anal Canal (SCAC)30.1.2026 15:29:00 CET | Press release

Pending the European Commission decision, Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) will be the first PD-1 immunotherapy treatment for patients with advanced squamous cell carcinoma of the anal canal (SCAC) in EuropeGlobally, the prevalence of SCAC is estimated at around 1 or 2 cases per 100,000 people, with a higher incidence in women than in men1,2,3The Committee for Medicinal Products for Human Use (CHMP) positive opinion is based on data from the Phase 3 POD1UM-303/InterAACT2 trial which showed patients with advanced SCAC achieved significantly improved progression-free survival with Zynyz in combination with carboplatin and paclitaxel as a first-line treatment4 Incyte (Nasdaq:INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Zynyz® (retifanlimab) in combination with carboplatin and paclitaxel (

Mediawan to Acquire The North Road Company, Creating a New Global Independent Content Platform30.1.2026 13:32:00 CET | Press release

Mediawan, the leading independent European studio led by Pierre-Antoine Capton, co-founded by Capton, Xavier Niel and Matthieu Pigasse, today announced the signing of an agreement to acquire The North Road Company (“North Road”), the preeminent independent U.S.-based studio founded by Peter Chernin. The combination creates one of the world’s largest independent studios with major creative hubs in the five continents and capabilities spanning all genres, formats and audiences. Together, Mediawan and North Road will have a stronger ability to accelerate the development of powerful IP, foster fresh creative synergies through format adaptations and co-production opportunities, and deliver ever greater value to viewers, talent and partners worldwide. The acquisition brings together two of the most dynamic independent studios in the sector with world-class creative talent, premium IP, and the scale to deliver content at the highest level. In an industry undergoing significant consolidation,

BrightSign Powers Intelligent Signage Experiences at ISE 202630.1.2026 09:00:00 CET | Press release

The Latest Players and AI Capabilities Drive Captivating, Personalized, and Interactive Signage With more industries embracing the power of visual storytelling, BrightSign, the provider of the most advanced, capable, and trusted digital media players and operating system, will showcase the latest developments in digital signage technology at ISE 2026 in Barcelona, Spain from February 3-6, 2026. BrightSign’s latest innovations come to life at booth #4S-150 through interactive real-world demos featuring retail, QSR, transportation, and corporate use cases. Visitors can test new AI-powered object detection capabilities of BrightSign players, allowing them to pick up an object and see the content on the screen respond immediately. Booth activations will be powered by BrightSign’s reliable platform including bsn.Control, BrightSignOS™, brightAuthor connected, and its global partner ecosystem. “In today’s immersive, personalized and visual world, the stakes have never been higher for powerfu

Candela Ushers in a New Era of Aesthetic Innovation at IMCAS Paris With the Launch of the Glacē™ System30.1.2026 08:30:00 CET | Press release

Iconic Vbeam® Pro and Matrix™ Systems showcased ahead of broader commercial availability Candela, a global leader in energy-based aesthetic technologies, today announced the European launch of the Glacē™ System, a facial treatment platform that signals a bold new chapter for the company and the future of aesthetic medicine. In addition to the launch of the Glacē System, Candela will also showcase its Matrix system for radiofrequency-based skin renewal and its iconic Vbeam® Pro vascular treatment platform at IMCAS 2026. Both Matrix and VBeam Pro platforms are currently available in select EMEA markets and are expected to be comprehensively launched shortly, further strengthening Candela’s leadership in the energy-based device market. Unveiled at the IMCAS World Congress 2026, these launches underscore Candela’s continued commitment to delivering innovative, science-backed treatment solutions for high-demand patient needs. Candela leads the industry in clinical efficacy and safety, suppo

Merz Therapeutics Appoints Dan Staner as President, Region Europe30.1.2026 08:00:00 CET | Press release

Merz Therapeutics today announced the appointment of Dan Staner as President, Region Europe, effective February 1, 2026. In this role, Dan will oversee the company’s European business and drive regional growth. Dan will report directly to Merz Therapeutics Chief Executive Officer, Stefan König, and will join the Therapeutics Executive Team. His appointment reflects the company’s continued commitment to strengthening its leadership capabilities and accelerating its growth strategy across key European markets.​ “Dan brings a strong track record of building and scaling biopharmaceutical businesses across Europe,” said Stefan König, CEO of Merz Therapeutics. “His deep commercial, strategic, and regional leadership experience will be instrumental in advancing our growth ambitions, expanding patient access to our therapies, and further strengthening our presence in Europe. We are very pleased to welcome Dan to Merz Therapeutics.”​ Throughout his career, Dan has held senior leadership roles i

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