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

Hisense Delivers 38% Sales Uplift in Western Europe Markets With NIQ’s AI-Powered Market Intelligence6.5.2026 05:00:00 CEST | Press release

NIQ insights drive international expansion and measurable growth for Hisense across key global markets NIQ (NYSE: NIQ), a global leader in consumer intelligence, today shared new learnings from its long-standing collaboration with Hisense, a leading global brand in home appliances and smart technologies. Using NIQ’s AI‑powered market intelligence, Hisense has accelerated international expansion, improved local market decision-making, and delivered measurable growth across more than 20 key markets and 12+ categories. The case study demonstrates how AI‑driven insights help global brands move faster, localize better, and compete more effectively in complex markets. The Challenge As Hisense expanded internationally, it faced rising complexity across global markets. Consumer preferences differed sharply across regions such as Western Europe, Eastern Europe, and Latin America, making a one‑size‑fits‑all approach ineffective. NIQ’s AI‑powered intelligence delivered the local market depth need

Samsung Bioepis Announces Positive Preliminary Phase 1 Data for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)6.5.2026 01:00:00 CEST | Press release

Phase 1 study has demonstrated pharmacokinetics (PK) equivalence between SB27 and KeytrudaPhase 1 and Phase 3 studies expected to be completed within 2026 Samsung Bioepis Co., Ltd. announced today that the Phase 1 study on SB27, a proposed biosimilar to Keytruda1 (pembrolizumab), has met its primary pharmacokinetics (PK) endpoints. The randomized, double-blind, three-arm, parallel group, multicenter clinical trial demonstrated pharmacokinetic bioequivalence of SB27 (pembrolizumab) to the reference product Keytruda. Initiated in January 2024, Phase 1 study is being conducted in four countries, and is expected to be completed by November 2026.2 The study assessed pharmacokinetics, efficacy, safety, and immunogenicity of SB27, EU-sourced Keytruda, and US-sourced Keytruda in patients with stage II or IIIA non-small cell lung cancer (NSCLC) following complete resection and adjuvant platinum-based chemotherapy. 163 participants were randomized to receive SB27, EU-sourced Keytruda, or US-sour

Megaport Launches Built-In DDoS Protection Enabling On-Demand Network Resilience6.5.2026 00:00:00 CEST | Press release

Megaport DDoS Protection removes the trade-off between security, performance, and cost, offering rapid enterprise-grade mitigation. Megaport Limited (ASX: MP1) (“Megaport”), a leading global automated infrastructure platform, today announced the launch of Megaport DDoS Protection. This new, built-in security capability for Megaport Internet allows customers to filter malicious traffic directly within the Megaport network rather than routing it through a separate or external service, for mission-critical uptime without introducing additional latency or routing complexity. As enterprises increasingly migrate to distributed cloud environments, traditional DDoS mitigation has struggled to keep pace with cloud and distributed infrastructure adoption. Standard ISP solutions often resort to dropping all traffic and taking the service offline to protect the network, while external third-party providers force a "security detour" that reroutes traffic through public infrastructure, introducing s

IFF Reports First Quarter 2026 Results5.5.2026 22:23:00 CEST | Press release

Delivered solid top and bottom line Q1 resultsProgressing disciplined sale process for Food Ingredients businessReaffirms Full Year 2026 Financial Guidance IFF (NYSE: IFF) reported financial results for the first quarter ended March 31, 2026. First Quarter 2026 Consolidated Summary: Management Commentary “IFF is off to a solid start in 2026, with first quarter results that reflect the customer focus and operational execution we’ve been building across the company,” said Erik Fyrwald, CEO of IFF. “We delivered volume growth in all four segments, improved profitability, and generated strong cash flow in the first quarter. As we look ahead, we are maintaining a disciplined approach to how we are planning the balance of the year as the current operating environment remains unsettled. We remained focused on advancing our commercial and innovation pipelines, driving productivity, and working with customers to offset inflation. This – when combined with our solid start to the year – derisks t

Logitech Announces Q4 and Full Fiscal Year 2026 Results5.5.2026 22:06:00 CEST | Press release

Strong FY 2026 Demonstrates Strategy and Operating Principles Are Delivering SIX Swiss Exchange Ad hoc announcement pursuant to Art. 53 LR — Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the fourth quarter and full Fiscal Year 2026. For Fiscal Year 2026: Sales were $4.84 billion, up 6 percent in US dollars and 4 percent in constant currency compared to the prior year. GAAP operating income was $775 million, up 18 percent compared to the prior year. Non-GAAP operating income was $911 million, up 18 percent compared to the prior year. GAAP earnings per share was $4.80, up 16 percent compared to the prior year. Non-GAAP EPS was $5.78, up 19 percent compared to the prior year. Cash flow from operations was $1.04 billion. The year-ending cash balance was $1.7 billion. The Company returned $768 million of cash to shareholders through its annual dividend payment and share repurchases. For Q4 Fiscal Year 2026: Sales were $1.09 billion, up 7 percent in

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