The new Taiwanese drama to air on Netflix, iQIYI, NOW TV and Singtel beginning in May

TAIPEI, May 5, 2026 /PRNewswire/ — KC Global Media Distribution has announced the upcoming worldwide premiere of the new ten-episode Taiwanese series “A Controversial Entertainer.” The highly anticipated comedic drama, which was introduced by KC Global Media Distribution at last year’s Asia TV Forum & Market (ATF), is set to premiere on Netflix, iQIYI and NOW TV on May 15. Singtel will follow June 8. Additional territories will be announced in the near future.

“A Controversial Entertainer” follows the story of Pan Hao, a petty gangster whose insatiable desire for diamonds leads him into the confines of a psychiatric hospital. Amidst the frenzy of being pursued, he and a group of people each with their own hidden stories, take refuge in a male escort club. In a turn of absurd and glamorous fate, they transform into five sought-after escorts. The cast includes Shih Chih Tian, Wes Lo, Alex Chou, Ben Wu, Marcus Chang and Chen I. The show will air in Mandarin with English subtitles.

“We are delighted by the strong momentum ‘A Controversial Entertainer’ has gained following our KC Global Media distribution showcase at ATF 2025,” said Bonnie Wiryani, Vice President, Revenue and Head of Content Sales, KC Global Media. “The level of interest not only reinforces our commitment to championing Asian content but also opens up opportunities for remakes and localized adaptations across the globe, with several partners already expressing keen interest in this title. We look forward to bringing the content to audiences around the world.”

KC Global Media’s latest global deal reinforces its continued commitment to growing its distribution arm, expanding strong creative partnerships, and delivering a diverse lineup of high-quality stories with broad international appeal, shining a spotlight on Asian storytelling.

Trailer:
https://youtu.be/WwUc7mqSUn8?si=GPVUt9b5fTCIdXmZ

About KC Global Media

KC Global Media Entertainment LLC is a global multi-media company headquartered in the United States, with offices in Singapore, Taiwan, Malaysia, China, The Philippines, and South Korea. The brainchild of former Sony executives Andy Kaplan and George Chien, KC Global Media Asia (KCGM Asia) is Asia’s leading entertainment hub through the production, distribution and programming of quality, ground-breaking content. Backed by over three decades of industry experience, KCGM Asia boasts an impressive portfolio of premium brands in Asia, including English-language general entertainment network AXN, Japanese anime content network Animax, Korean general entertainment network, ONE, Japanese entertainment network, GEM, English language general entertainment FAST network, KCM, and AXN Sports.

KCGM Asia also expanded its distribution footprint by announcing a joint venture with JOURNY of NextTrip, Inc., bringing luxurious travel-lifestyle content across India, Southeast Asia, Australia and New Zealand, creating a powerful source of travel inspiration with a reach of 250 million viewers. By combining award-winning and well-loved entertainment formats with extensive knowledge and insight into the Asia Pacific market, KCGM Asia is paving the way for a new standard of entertainment in Asia and beyond.

Website: www.KCGlobalMedia.com | Facebook: @KCGlobalMedia | Instagram: @KCGlobalMediaAsia | LinkedIn: @KCGlobalMediaAsia

New capabilities help enterprises, governments, and service providers operationalize digital sovereignty with continuous compliance and control across hybrid environments

BOSTON, May 5, 2026 /PRNewswire/ — At Think 2026, IBM (NYSE: IBM) today announced the general availability of IBM Sovereign Core, a new software platform designed to help organizations build and operate AI-ready sovereign environments and verify their control — giving enterprises and governments an end-to-end approach to digital sovereignty.

IBM Corporation logo.

As AI adoption accelerates, digital sovereignty has become a critical requirement, extending beyond data residency to include control over infrastructure, operations, and AI systems. Organizations must balance maintaining necessary authority with the pace of innovation, while facing increasing scrutiny from regulators, auditors, and boards. Yet most platforms can struggle to provide consistent, auditable answers to these requirements — creating a gap between policy and operational reality.

“AI has made sovereignty a runtime requirement, not a policy statement. With IBM Sovereign Core, organizations don’t have to choose between deploying AI at speed and verifying their control. Sovereignty shouldn’t be a constraint on innovation — with the right software foundation, it’s an enabler of it,” said Dinesh Nirmal, SVP, IBM Software.

Defining Digital Sovereignty for the AI Era
IBM defines digital sovereignty across four pillars:

• Operational Sovereignty — Control over how environments are operated
• Data Sovereignty — Control over data at rest, in use, and in motion
• Technology Sovereignty — Open, modular architecture that avoids vendor lock-in
• AI Sovereignty — Control over where models run and how inference is governed

Together, these pillars form the foundation of IBM’s unified approach to digital sovereignty—bringing control across operations, data, technology, and AI.

A Unified Approach for Digital Sovereignty
IBM Sovereign Core introduces a new model for operational sovereignty, where governance, compliance, and control are built into the system from the start to enable organizations to scale AI while maintaining their sovereignty, trust, and operational independence. IBM Sovereign Core delivers an integrated sovereign software platform that combines control plane, identity, security, compliance, and AI execution functions operate within a single deployment model.

Key capabilities include:

• Customer-operated control plane enabling full authority over configuration, operations, and lifecycle management
• In-boundary identity, encryption, and data services, ensuring all access, secrets, keys, logs, and audit evidence remain under customer control
• Continuous compliance monitoring and evidence generation, providing real-time audit readiness
• Preloaded regulatory frameworks to accelerate company defined compliance postures across regions and industries
• Governed AI execution, ensuring models, inference, and agent operations run within defined sovereign boundaries
• Open, modular architecture built on open standards, supporting portability and avoiding vendor lock-in

Together, these capabilities establish a sovereign control plane that enables organizations to operate environments and verify their control across data, operations, and AI.

Continuous, Verifiable Compliance
IBM Sovereign Core enables organizations to move from static compliance models to dynamic continuous, verifiable compliance models that are verifiable. Integrated monitoring, drift detection, and automated evidence generation allow organizations to:

• Validate compliance in real time
• Maintain audit-ready evidence within the sovereign boundary
• Reduce reliance on manual validation and point-in-time audits

This ensures sovereignty is not only defined, but observable, enforceable, and provable at scale.

AI Governance Within Your Sovereign Boundary
As AI systems become central to enterprise operations, governance must extend beyond data to include models, inference, and agent behavior. IBM Sovereign Core enables organizations to deploy and operate AI models, agents, and inference workloads entirely within the sovereign boundary, ensuring their:

• Control over where AI processing occurs
• Traceability of model execution and decisions
• Governance over access, updates, and lifecycle management

This ensures that AI systems operate with accountability, transparency, and control, even in highly regulated environments.

Extensible Ecosystem and Deployment Flexibility

Built on open, enterprise-grade technologies like Red Hat OpenShift and Red Hat AI, IBM Sovereign Core enables organizations to extend existing investments across hybrid and partner environments.

 IBM Sovereign Core includes an extensible catalog that organizations can curate for their own users, with their own applications, or populated with pre-vetted IBM, third-party and open source software and services from an ecosystem of software and infrastructure partners that includes: AMD, ATOS, Cegeka, Cloudera, Dell, Elastic, HCL, Intel, Mistral, MongoDB, and Palo Alto Networks.

CPU, GPU, and AI inference environments can be provisioned using standardized templates and automated configuration profiles, enabling teams to deploy and manage workloads consistently across sovereign regions while maintaining alignment to their compliance and sovereignty requirements.

Designed for Regulated Regions, Enterprises and Governments
IBM Sovereign Core is designed for organizations that require greater control, flexibility, and compliance across sensitive workloads.

• Enterprises can run regulated applications and AI workloads within controlled environments
• Governments and public sector organizations can support sovereign operations for critical services
• Service providers and regional cloud operators can deliver sovereign cloud and AI services at scale

Across these use cases, IBM Sovereign Core enables organizations to innovate with AI while maintaining demonstrable authority over their systems, data, and operations. IBM Sovereign Core is now generally available.

Supporting Quotes
“Control and compliance have long been barriers to enterprise AI adoption,” said Marjorie Janiewicz, Chief Revenue Officer at Mistral AI. “IBM Sovereign Core delivers a ready-to-deploy foundation that allows our models to operate within trusted boundaries from day one, enabling organizations to accelerate AI adoption while maintaining full control over their data. We’re pleased to be the first model provider partner for Sovereign Core to certify our frontier models and support enterprise customers globally.”

“AI is reshaping how nations, governments and enterprises operate, making digital sovereignty not just a policy discussion, but a leadership priority,” said Philip Guido, EVP & Chief Commercial Officer, AMD. “As organizations deploy AI at scale, control over technology becomes increasingly critical. Together with IBM and Red Hat, we’re enabling clients to exercise greater autonomy and flexibility in their digital sovereignty choices across the full IT stack through an open, secure and transparent approach.”

“As organizations navigate increasingly complex compliance and regulatory requirements, we’re seeing strong demand for digital platforms and software that allows sensitive data to remain within controlled, compliant boundaries,” said Gaetan Willems, VP Cloud & Digital Platforms, Cegeka. “Partnering with IBM to offer a pre-architected solution through our in-country environment enables us to deliver enterprise-ready software to our clients, while allowing them to address local compliance standards.”

“As part of our strategic alliance with IBM, Deloitte is focused on enabling a Sovereign Core technology stack that supports clients in building secure, scalable, and compliant cloud ecosystems. Leveraging IBM’s platform capabilities alongside Deloitte’s deep regulatory and transformation expertise, we help organizations address critical imperatives such as data localization, security, regulatory compliance, and India’s DPDP requirements.”  — Vinay Prabhakar  Chief Commercial Officer Deloitte AP & National Sales & Alliances Leader Deloitte South Asia

“India deserves cloud infrastructure that is sovereign by design. At NxtGen, that has always been our operating principle and our promise to customers: superior performance, lower TCO, and zero trade-offs on compliance. The IBM Sovereign Core collaboration is a direct expression of that commitment, bringing secure, compliant cloud capabilities built for India’s regulatory reality.” — A S Rajgopal, MD & CEO, NxtGen

“The ability to establish—and prove—control over data, models and operations is quickly becoming a differentiator for trust, resilience and innovation in AI adoption,” said Bill Pearson, vice president of data center and AI software, Intel Data Center Group. “Establishing sovereign AI frameworks, spanning open hybrid architectures and transparent governance, requires a foundation built for performance, security, and control. Intel continues to innovate with technologies such as Intel Xeon 6 processors and Intel TDX to provide in‑use protection for data and AI workloads across environments with CPU and GPUs to support sovereign infrastructure initiatives like IBM Sovereign Core.”

Supporting Materials
Blog: IBM Sovereign Core: The new end to end system for Sovereign AI
IBM Sovereign Core Product Page
IBM Sovereign Core Ecosystem Catalog
IBM Sovereign Core Compliance Center
Statement of Direction for IBM Sovereign Core

About IBM
IBM is a leading provider of global hybrid cloud and AI, and consulting expertise. We help clients in more than 175 countries capitalize on insights from their data, streamline business processes, reduce costs and gain the competitive edge in their industries. Thousands of governments and corporate entities in critical infrastructure areas such as financial services, telecommunications and healthcare rely on IBM’s hybrid cloud platform and Red Hat OpenShift to affect their digital transformations quickly, efficiently and securely. IBM’s breakthrough innovations in AI, quantum computing, industry-specific cloud solutions and consulting deliver open and flexible options to our clients. All of this is backed by IBM’s long-standing commitment to trust, transparency, responsibility, inclusivity and service.

Visit www.ibm.com for more information.

Media contact:

Kate Lehman
IBM
Kate.Lehman@ibm.com

Multicenter, open-label study will evaluate the safety and preliminary efficacy of CK0802, a first-in-class, off-the-shelf Treg therapy, in patients with steroid-refractory GVHD

HOUSTON, May 5, 2026 /PRNewswire/ — Cellenkos^®, Inc., a clinical stage biotechnology company, pioneering allogeneic, tissue-targeted regulatory T cell (Treg) therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application to initiate a Phase 1b/ 2a clinical trial of CK0802 for the treatment of patients with steroid-refractory graft-versus-host disease (GVHD).

Steroid-refractory GVHD represents a critical unmet need in post-transplant care. While allogeneic stem cell transplants are curative for many blood cancers, the procedure carries the risk of GVHD—a condition where donor cytotoxic T cells “misfire,” recognizing the patient’s healthy organs as foreign and launching a systemic attack. This typically manifests as severe skin rashes, debilitating diarrhea, and liver failure.

Current first-line treatment relies on high-dose intravenous steroids. However, steroids act as a “blunt instrument,” suppressing the aggressive T cells while simultaneously depleting the healthy immune system, leaving patients vulnerable to life-threatening infections. In nearly 50% of cases, steroids fail to calm the immune attack. Currently available second-line therapies often struggle to provide lasting results, frequently hampered by severe immunosuppression and hematologic toxicities. Due to these limitations, patients face a poor prognosis, with two-year survival rates currently stagnating at approximately 30%. Novel therapies are urgently needed.

“FDA clearance to advance CK0802 into a Phase 1b/ 2a trial marks a hopeful step forward for patients facing the dire prognosis of steroid-refractory GVHD,” said Simrit Parmar, MD, MSCI, Founder of Cellenkos, and Faculty, Texas A&M, School of Engineering and Medicine (EnMed). “CK0802 is uniquely qualified to function under intense inflammatory stress, resetting the patient’s immune system, and de-escalating donor T-cell attack without the toxicities typically associated with broad-spectrum immunosuppression.”

About the CK0802 Phase 1b/ 2a Study
The multicenter, open-label Phase 1b/ 2a trial is designed to evaluate the safety, tolerability, and preliminary efficacy of multiple infusions of CK0802.

• Target population: Patients with GVHD who have failed to respond adequately to systemic corticosteroid therapy following allogeneic stem cell transplantation.
• Primary endpoint: Safety and early efficacy of CK0802 as assessed by overall response rate (ORR) at Day 29.

The trial is scheduled to commence in the second half of 2026, with a clinical readout anticipated in early 2027.

How can CK0802 treat Steroid Refractory GVHD?
In cases of steroid-refractory GVHD, patients face a life-threatening “vicious loop” of injury and inflammation. This condition is driven by aggressive donor T cells that relentlessly attack the recipient’s organs, triggering the release of inflammatory cytokines that further fuel the disease’s progression. CK0802 Tregs are designed to break this cycle. Hardwired to remain resilient even under intense inflammatory conditions, CK0802 delivers a concentrated dose of “young,” highly functional regulatory T cells (Tregs). These cells employ a multi-faceted biological approach to suppress runaway inflammation at the source, actively promoting long-term immune stability.

• Direct Suppression: By releasing suppressor cytokine, IL-10, CK0802 Tregs apply “molecular brakes” to the immune system, inhibiting pro-inflammatory mediators (TNF-α, IL-6, IL-12, and IL-17), preventing further tissue injury.
• Indirect Starvation: CK0802 Tregs act as “cytokine sinks,” utilizing high-affinity surface receptors to rapidly consume, IL-2, a survival cytokine for aggressive T cells. By draining this lifeline, CK0802 effectively starves and depletes the cytotoxic T cells responsible for attacks on target organs.
• APC Neutralization: CK0802 Tregs take aim and neutralize Antigen-Presenting Cells (APCs), which are the primary drivers of GVHD. By silencing these “masterminds”, CK0802 extinguish the “cytokine storm” and resolve the inflammatory chaos, to establish durable immune homeostasis.
• Infectious Tolerance Induction: Beyond immediate action, CK0802 retrain the patient’s endogenous regulatory T cells, recruiting the host’s immune system to sustain long-term healing and maintain equilibrium.

“Clearance of our IND application is a major milestone for Cellenkos and confirms that the FDA is satisfied with the clinical, preclinical and manufacturing data submitted in support of CK0802, further validating our CRANE^® manufacturing platform,” said Tara Sadeghi, Chief Operating Officer of Cellenkos. “This trial will provide critical data to guide the design of future, pivotal studies. We believe that CK0802 will be a transformational therapy for steroid refractory GVHD patients who tragically have limited options today.”

Acting as an immunological “crusader,” CK0802 is specifically trained to thrive within intense inflammatory environments and home directly towards injured tissues to suppress donor-driven immune attacks, effectively re-establishing immune homeostasis.

CK0802 Phase 1 Trial Outcomes
Results from a randomized, placebo-controlled trial demonstrate that CK0802 Tregs are a safe and highly effective treatment for critically ill COVID-19 ARDS patients, requiring mechanical ventilation and vasopressor support, thought to be driven by severe “cytokine storm” inflammation, like that seen in GVHD. All patients had failed traditional steroid therapy. Bayesian regression analysis revealed a probability of beneficial effect (PBE) of 89.7% for being alive and extubated at day+28 in recipients of multiple infusions of CK0802 at a fixed dose of 100 million Tregs compared to placebo. Long-term data showed a 98.6% PBE for overall survival at the one-year mark, alongside significant improvements in cognitive function and general quality of life six months after hospital discharge in favor of CK0802 at the same dose. These findings suggest that CK0802 could fundamentally shift the prognosis for patients facing the most life-threatening respiratory complications of the virus.

About CK0802
Derived from qualified U.S. public cord blood units in compliance with 21 CFR Part 1271, CK0802 is a pioneering, “off-the-shelf” cryopreserved Treg therapy. Featuring a robust shelf life of nearly three years, this investigational treatment is designed for immediate intravenous administration without the logistical delay of HLA matching. This “ready-to-use” capability is critical for steroid-refractory GVHD patients, where rapid intervention is essential for survival and every hour counts.

At the core of the CK0802 are “supercharged,” intelligent regulatory T cells (Tregs) that preserve their cellular naivety. This unique state facilitates rapid in vivo proliferation, enabling the cells to expand aggressively once inside the patient to mount a powerful suppression of the rogue elements. Furthermore, these cells possess a specialized “target readiness” that drives a gain of function; allowing for the swift resolution of dysregulated inflammation—the primary biological driver of GVHD—restoring balance to the immune system when it is needed most.

About Graft-versus-Host Disease
Graft-versus-host disease (GVHD) remains one of the most significant and life-threatening complications following allogeneic hematopoietic stem cell transplantation. Approximately 11,000 allogeneic stem cell transplants are performed annually in the United States, and 80,000 worldwide. Despite modern prophylactic measures, acute GVHD occurs in approximately 50% of transplant recipients, and chronic GVHD impacts between 30% and 70% of patients, severely affecting long-term quality of life and non-relapse mortality. Current standard-of-care treatments rely heavily on high-dose corticosteroids, yet these interventions are only effective in roughly 50% of cases. For those with steroid-refractory disease, the prognosis is often dismal, with 2-year survival rates historically recorded near 30%, highlighting a critical unmet medical need for novel, more effective therapeutic options.

About Cellenkos^®, Inc.
Cellenkos^® is a Houston-based, fully integrated, biotechnology company focused on developing transformative Treg therapies for inflammatory diseases and autoimmune disorders. Cellenkos was granted US patent (US12472182B2) on November 18, 2025, for their technology covering “Compositions comprising regulatory T cells and methods of producing and using them”. Leveraging its proprietary CRANE^® technology, Cellenkos develops off-the-shelf Treg product candidates designed to suppress inflammation and support tissue repair. The company’s pipeline includes candidates for aplastic anemia (CK0801); amyotrophic lateral sclerosis, dementia, and psoriasis (CK0803); and myelofibrosis, type 1 diabetes, and inflammatory bowel disease (CK0804).

For more information, please visit www.cellenkosinc.com.

Media and Investor Contact: contact@cellenkosinc.com

Forward-Looking Statements
This press release contains forward-looking statements regarding the clinical development of CK0802. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected.

Alongside new availability on AWS ap-southeast-1, Pinecone announces Nexus knowledge engine, KnowQL query language, Marketplace, Builder tier, and native full-text search

SINGAPORE, May 5, 2026 /PRNewswire/ — Pinecone, the knowledge infrastructure for AI at scale, today announced the launch of its first serverless region in Asia with the AWS Asia Pacific (Singapore) Region (ap-southeast-1), bringing its full serverless vector database and knowledge infrastructure to the Asia-Pacific market. The new region enables organizations across Southeast Asia, Australia, and the broader Asia-Pacific to run AI workloads with low-latency performance and local data residency.

The Singapore region launch coincides with a series of major product announcements from Pinecone, including the introduction of Pinecone Nexus, a knowledge engine for AI agents; KnowQL, a declarative query language for agentic retrieval; the Pinecone Marketplace with more than 90 production-ready knowledge applications; a new Builder tier at $20 per month; native full-text search in the core Pinecone database; and Dedicated Read Nodes for high-throughput, low-latency production workloads delivering up to 97% cost reduction at scale.

“The best knowledge infrastructure should be accessible to every builder, in every region,” said Ash Ashutosh, CEO of Pinecone. “Launching our first serverless region in Asia marks a significant milestone for Pinecone. Organizations across the Asia-Pacific now have access to the same infrastructure that more than 9,000 customers worldwide rely on — with the data residency, low latency, and proximity that enterprises in the region require. Combined with today’s launches of Nexus, KnowQL, Marketplace, and our new Builder tier, we are delivering the most comprehensive knowledge infrastructure for AI at a scale and price point that removes every barrier to building.”

Pinecone Nexus: The Knowledge Engine for Agents

As AI shifts from assistive applications to autonomous agents, the demands on knowledge infrastructure are changing fundamentally. Roughly 85% of an agent’s effort today is spent on context retrieval, resulting in task completion rates of just 50–60%, unpredictable completion times, and runaway token costs. Pinecone Nexus addresses this by moving reasoning upstream, from retrieval to knowledge compilation. Its context compiler transforms raw data into task-optimized artifacts that agents consume directly, while its composable retriever serves those artifacts with low latency, per-field citations, and deterministic conflict resolution. Early results show up to 90% reduction in token usage, task completion rates above 90%, and 30x faster time-to-completion.

At the core of Nexus is KnowQL, a declarative query language that gives agents a universal interface for knowledge access, replacing custom tool definitions and bespoke glue code with a single call that specifies output format, citation requirements, and latency budgets, and returns trusted, structured, grounded knowledge.

Pinecone Marketplace

The Pinecone Marketplace is a catalog of fully working, production-ready knowledge applications that users can deploy, customize, and run immediately. It launches with more than 90 production-ready solutions across sales and revenue, insurance, real estate, legal and compliance, people and HR, customer support, and more categories. Built by Pinecone and partners, these applications require no infrastructure assembly. The Marketplace is free at launch, with partner-built commercial solutions coming soon.

New Pricing and Infrastructure Updates

Pinecone’s new Builder tier provides full access to its production-grade infrastructure for $20 per month and free support. Dedicated Read Nodes offer provisioned read capacity with warm data paths and fixed hourly pricing, delivering 77–97% cost reduction at scale for sustained high-throughput workloads. Bring Your Own Cloud (BYOC) deploys Pinecone fully managed within a customer’s own cloud environment for organizations with data residency or regulatory requirements. Additionally, Pinecone has integrated native full-text search into its core database, now in public preview, enabling hybrid retrieval that combines semantic breadth with exact-match precision for agent-scale query volume.

The Singapore region is available now. It is Pinecone’s first serverless region in Asia, joining existing serverless regions on AWS in the United States and Europe, with additional regions planned.

Get started here. For more detailed information on today’s announcements, dive into the blog.

About Pinecone

Pinecone is the knowledge infrastructure for AI at scale. Its leading vector database and knowledge engine, Pinecone Nexus, power accurate, performant AI applications for more than 9,000 customers and 800,000 developers worldwide. Pinecone’s mission is to make AI knowledgeable. For more information, visit pinecone.io.

Media Contact:
Mike Sefanov
mike.s@pinecone.io
Sr. Director, Communications

MELBOURNE, Australia and INDIANAPOLIS, Ind., May 5, 2026 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces the publication of a new independent analysis of Phase 3 ZIRCON trial data in European Urology^[1], demonstrating that TLX250‑Px (Zircaix®^[2], ⁸⁹Zr-girentuximab) PET/CT^[3] imaging may be highly predictive of renal malignancy across all subtypes, not limited to clear cell renal cell carcinoma (ccRCC).

Recognizing that carbonic anhydrase IX (CAIX) expression is also observed in other renal cancer subtypes^[4], this subsequent analysis conducted by international investigators who participated in ZIRCON Phase 3 trial^[5], evaluated centrally reviewed imaging and pathology data to explore whether tracer uptake in renal masses correlated with malignancy beyond ccRCC.

The analysis demonstrated that positive PET findings were highly predictive of malignancy overall, including in non-clear cell renal cell carcinoma (nccRCC), with a reported positive predictive value (PPV) of 98% (95% CI, 96–99), sensitivity of 82% (95% CI, 82–90), and specificity of 87% (95% CI, 81–93). These exploratory scientific findings suggest TLX250-Px has applications beyond the detection of ccRCC in primary renal masses and may have implications to management of nccRCC.

Aboubacar Kaba, MD, urologist at the University of California, Los Angeles and corresponding author, commented: “This analysis shows that when TLX250-Px PET/CT is positive, it is highly predictive of renal malignancy, including beyond ccRCC. Thus, the utility of this test may be important in distinguishing more hypoxic, and therefore, aggressive disease from indolent tumors with clear treatment implications. This may provide an additional tool to aid in risk stratifying or guiding patient and clinician decisions in the treatment of renal masses.”

Dr. David N. Cade, Group Chief Medical Officer at Telix, added: “Publication of these data in European Urology reflects the scientific strength of the ZIRCON trial and the robustness of its central imaging and pathology review. While ZIRCON was designed to address ccRCC, this analysis supports continued evaluation of TLX250-Px PET imaging across a broader spectrum of renal malignancies, with potential application in the management of patients with non-clear cell RCC. Furthermore, essentially all false-positives for ccRCC in the ZIRCON study have now been shown to be other malignant kidney cancer subtypes, reducing the risk of overtreatment and further supporting clinical adoption.”

The full paper is available at: https://www.europeanurology.com/article/S0302-2838(26)02037-3/fulltext.

These findings are based on exploratory analyses and were not the basis of Telix’s Biologics License Application (BLA) submission for TLX250-Px, which focuses exclusively on detection of ccRCC in primary renal masses.

About TLX250-Px

TLX250-Px is a PET imaging candidate under development for the diagnosis and characterization of ccRCC, and included in leading international guidelines for renal imaging^[6]. It works by specifically binding to carbonic anhydrase IX (CAIX), a validated target protein expressed on >95% of ccRCC cells^[7], to produce images with high tumor-to-background ratio and high intra- and inter-reader consistency.

Telix’s pivotal Phase 3 ZIRCON trial evaluating TLX250-Px in 300 patients, of whom 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% positive predictive value (PPV) for ccRCC across three independent radiology readers^[8]. Telix believes this demonstrated the ability of TLX250-Px to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing and characterizing ccRCC.

ZIRCON-X, a noninterventional, prospective, post hoc study using imaging data from ZIRCON, found that almost half of all patients (48.6%) would have undergone a change in clinical management if imaged with TLX250-Px, compared with baseline standard-of-care (SOC) imaging, and that more than 20% could potentially have avoided an invasive biopsy^[9].

For more on TLX250-Px and Telix’s theranostic kidney cancer program, click here.

TLX250-Px has not received a marketing authorization in any jurisdiction.

About Telix Pharmaceuticals Limited

Telix is a global biopharmaceutical company focused on the development and commercialization of radiopharmaceuticals with the goal of addressing significant unmet medical need in oncology and rare diseases. Telix is headquartered in Melbourne (Australia) with international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland) and Japan. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.

Media Contact

Eliza Schleifstein
917.763.8106 (Mobile)
Eliza@schleifsteinpr.com

Legal Notices

Cautionary Statement Regarding Forward-Looking Statements.  

You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification.  To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress, completion and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, including TLX250-Px, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business, including as a result of war or other geopolitical conflicts; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

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