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First patient imaged in Phase III AMPLIFY trial with 64Cu-SAR-bisPSMA PET/CT

SYDNEY, May 29, 2025 /PRNewswire/ — Clarity Pharmaceuticals (ASX: CU6) (“Clarity” or “Company”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce that it has imaged the first patient in its registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in participants with biochemical recurrence (BCR) of prostate cancer, AMPLIFY (NCT06970847)[1], at XCancer in Omaha, Nebraska (NE).

Dr Luke Nordquist, Urologic Medical Oncologist, CEO, XCancer, commented, “We are thrilled to recruit the first participant in the AMPLIFY trial and to image them just over a week after study initiation. 64Cu-SAR-bisPSMA could become a best-in-class diagnostic prostate-specific membrane antigen (PSMA) agent, and we are honoured to be part of this registrational trial that intends to gather sufficient data for a New Drug Application (NDA) and a potential subsequent commercialisation of this next-generation product.

“We have already observed the potential benefits of 64Cu-SAR-bisPSMA based on data from earlier phase trials such as Clarity’s PROPELLER and COBRA studies and look forward to participating in the AMPLIFY trial, providing this optimised product to our patients in need of novel diagnostic solutions. The COBRA trial[2] that laid foundation for AMPLIFY in patients with BCR of prostate cancer showed that more lesions and more patients with a positive scan were identified on 64Cu-SAR-bisPSMA positron emission tomography (PET) compared to conventional scans and on next-day vs. same-day imaging. 64Cu-SAR-bisPSMA also allowed for the identification of lesions in the 2-mm range and was able to detect lesions at least 6 months earlier than the current standard-of-care (SOC) PSMA PET agents. The team at XCancer looks forward to further building on this evidence in the AMPLIFY trial as we progress towards our mutual goal of improving treatment outcomes for patients with cancer.”

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, “We are excited to have imaged the first patient in the AMPLIFY trial and look forward to further progressing recruitment and opening clinical sites across the United States (US) and Australia, providing access to 64Cu-SAR-bisPSMA in both countries as part of this trial. We have built a robust supply of copper-64 with a wide network of product manufacturers in preparation for our two Phase III trials, AMPLIFY in BCR and CLARIFY[3] in pre-prostatectomy, and potential commercialisation. As such, we are ideally positioned to build on the clinical advantages of 64Cu-SAR-bisPSMA based on its higher lesion uptake and contrast, increased lesion detection rate compared to SOC imaging and flexible imaging schedule, enabled by its dual targeting (bisPSMA), proprietary chelator technology (sarcophagine, SAR) and copper-64 properties. We are also prepared to fully leverage the logistical and supply chain advantages associated with the optimal half-life of this isotope, in comparison to short-lived gallium-68 and fluorine-18, which allows 64Cu-SAR-bisPSMA to be made centrally in one location and shipped on-demand to any treatment facility in the country. This model enables better access and geographic distribution, meaning men with cancer could get an accurate and early diagnosis whether their location is a major city or regional area, as long as there is a PET camera on site.

“With prostate cancer prevalence increasing year after year, we look forward to overcoming limitations of the current-generation PSMA PET diagnostics, such as sensitivity and accessibility, making earlier and more accurate detection of recurrent disease a potential reality and bringing our optimised diagnostic to more men with this insidious disease around the world.”

About the AMPLIFY trial

AMPLIFY’s official title is “64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants with Biochemical Recurrence of Prostate Cancer” (NCT06970847)[1]. It is a non-randomised, single-arm, open-label, multi-centre, diagnostic clinical trial of 64Cu-SAR-bisPSMA PET in participants with rising or detectable prostate-specific antigen (PSA) after initial definitive treatment.

The aim of this trial is to investigate the ability of 64Cu-SAR-bisPSMA PET/computed tomography (CT) to detect recurrence of prostate cancer, with evaluation across 2 imaging timepoints, Day 1 (day of administration, same-day imaging) and Day 2 (approximately 24 hours post administration, next-day imaging).

The study will enroll approximately 220 participants at multiple clinical sites across the US and Australia. As a pivotal trial, the final study results are intended to provide sufficient evidence to support an application to the US Food and Drug Administration (FDA) for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in BCR of prostate cancer.

About SAR-bisPSMA

SAR-bisPSMA derives its name from the word “bis”, which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

Disclaimer

67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA are unregistered products. The safety and efficacy of 67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that these products will become commercially available.

About Prostate Cancer

Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide[4]. Prostate cancer is the second-leading causes of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the US and around 35,770 deaths from the disease[5].

About Clarity Pharmaceuticals

Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancers.

www.claritypharmaceuticals.com

For more information, please contact:

Clarity Pharmaceuticals
Dr Alan Taylor                                                  Catherine Strong
Executive Chairperson                                  Investor/Media Relations
ataylor@claritypharm.com                               c.strong@morrowsodali.com
                                                                         +61 406 759 268

References

1.     ClinicalTrials.gov Identifier: NCT06970847, https://clinicaltrials.gov/ct2/show/NCT06970847

2.     Nordquist et al. COBRA: Assessment of safety and efficacy of 64Cu-SAR-bisPSMA in patients with biochemical recurrence of prostate cancer following definitive therapy. EANM, 2024.

3.     ClinicalTrials.gov Identifier: NCT06056830, https://clinicaltrials.gov/study/NCT06056830

4.     Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21660

5.     American Cancer Society: Key Statistics for Prostate Cancer, https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html

This announcement has been authorised for release by the Executive Chairperson.

Dx&Vx Accelerates Development of Universal COVID-19 Vaccine

  • Emerging as a next-generation vaccine amidst global resurgence of COVID-19
  • Expanding v arious pipelines other than universal COVID vaccine

SEOUL, South Korea, May 29, 2025 /PRNewswire/ — Bio-healthcare company Dx&Vx (DXVX) has officially announced the acceleration of its development program for a universal COVID-19 vaccine, following the recent acquisition of related technology. Designed to provide immunity against both current and future variants of the coronavirus, this next-generation vaccine is drawing global attention amid a new wave of COVID-19 cases worldwide.

Global health organizations, including the WHO, have raised concerns about rising COVID-19 cases in parts of Europe, Asia, and North America. These warnings have highlighted the urgent need for more robust and lasting immune solutions against evolving virus variants.

DXVX, a company led by COREE Group Chairman Chong-Yoon Lim, the eldest son of Hanmi Pharmaceutical Group’s founder, secured the universal vaccine technology late last year. The vaccine under development uses a virus-like particle (VLP) platform, which offers greater stability and ease of storage compared to mRNA vaccines. Theoretically, it has the potential to prevent infections caused by all known and future COVID-19 variants.

Currently, DXVX is advancing through the regulatory procedures necessary to initiate Phase 2 clinical trials in South Korea, the U.S., and Southeast Asia. After successfully completing Phase 1 trials in the U.S. and South Africa, the company is preparing its Investigational New Drug (IND) applications for global Phase 2 studies.

DXVX also acquired a universal COVID-19 treatment technology last year from LUCA AI Cell. DXVX stated, “Luca’s treatment technology has efficacy test data for dozens of lethal viruses, including COVID-19,” and added, “It is expected to enable the development of a new-concept COVID-19 treatment.”.

In addition to its universal COVID-19 vaccine and treatment, Dx&Vx (DXVX) is actively targeting the global pharmaceutical and biotech market through a diverse pipeline, including:

  • A next-generation mRNA vaccine platform capable of ultra-long-term storage at room temperature
  • An oral obesity treatment
  • The OVM-200 cancer vaccine based on the ROP platform technology.

In particular, the mRNA vaccine platform capable of ultra-long-term storage at room temperature is considered a game-changer, as it enables vaccination even in countries with limited cold-chain infrastructure, thereby lowering geographical barriers in responding to infectious diseases. Discussions to sign Material Transfer Agreements (MTAs) with major domestic and global mega pharmaceutical companies have recently accelerated, indicating that the platform has entered the late stages of licensing out, with visible outcomes expected within this year.

In addition, the oral obesity treatment, which is about to enter clinical trials, addresses the inconvenience of injection-based therapies while demonstrating effectiveness in improving fat metabolism, with related patents already filed. The OVM cancer vaccine represents a novel immuno-oncology approach targeting solid tumors and is also open to potential joint development with global pharmaceutical companies.

A DXVX spokesperson stated, “We are committed to advancing the development of the universal COVID-19 vaccine, while also preparing for potential future COVID-19 variants and lethal infectious diseases, such as ‘Disease X’.” The spokesperson added, “In addition to the major pipelines currently being promoted for licensing out, we are actively investing in R&D across multiple technology assets and expect sustainable long-term outcomes.”

How clean energy fuels the comeback of Shennongjia’s golden snub-nosed monkeys?

BEIJING, May 29, 2025 /PRNewswire/ — Finding Answers in China from China.org.cn:


How clean energy fuels the comeback of Shennongjia’s golden snub-nosed monkeys?

Deep in the lush and mysterious forests of Shennongjia, central China’s Hubei province, golden figures leap effortlessly through the treetops—these are the Shennongjia golden snub-nosed monkeys. Once on the brink of extinction, they’ve made a stunning recovery and are now even recognized as a unique subspecies. But what’s the story behind their stunning revitalization? How has China’s energy transition played a key role in protecting their habitat? And can China’s ecological wisdom offer new solutions for the world?

To find out, Peruvian host Rebeca Phang from China.org.cn teams up with global energy expert Professor Saifur Rahman for a journey into the heart of Shennongjia.

When clean energy meets biodiversity conservation, and when technology empowers nature to thrive, the answers may lie in the rhythm of the forest—and in China’s commitment to green development. This is more than a story about endangered monkeys; it’s a search for a new path to harmony between humanity and nature.

How clean energy fuels the comeback of Shennongjia’s golden snub-nosed monkeys?
https://youtu.be/Wj1Hd2OaZhE

MinIO AIStor Sets New Standard for AI and Data-Intensive Workloads with Industry-First AWS S3 Express API Support

Enterprise object storage with built-in replication brings S3 Express API performance to the entire data lakehouse, at no extra cost

REDWOOD CITY, Calif., May 29, 2025 /PRNewswire/ — MinIO, the leader in high-performance object storage for the exabyte AI era, today announced AIStor support for Amazon’s S3 Express API, a streamlined version of the general-purpose S3 API designed to deliver maximum performance for AI and data-intensive analytics workloads. MinIO AIStor is the first and only AI data storage platform to adopt Amazon’s S3 Express API and enable organizations to put all of their analytical and AI data, not just a subset, in “express mode” at no extra cost.

Introduced by AWS in 2023 and delivered via the Amazon S3 Express One Zone storage class, the Amazon S3 Express API has defined a new industry standard for high performance and developer-friendly AI and analytics storage, delivering 10x faster performance compared to the S3 Standard storage class. But, in AWS, the enhanced performance of AWS S3 Express One Zone comes at over five times the cost of S3 Standard to store data and doesn’t come with data protection and replication capabilities. Consequently, to use it safely, customers must save a durable copy of their data in S3 standard and copy data that requires high speed access into S3 Express One Zone.

With this release, MinIO is democratizing access to and use of this powerful API for all data processing needs by coupling its dramatic performance advantages with full active/passive, disaster recovery (DR), and batch replication support, all at no extra cost. Enterprises can continue leveraging the general purpose S3 API for raw source data requiring versioning and immutability before any processing, but can now leverage the high performance S3 Express API for all other downstream workloads and derived data sets, especially, but not limited to, high intensity data processing. This includes the majority of data lakehouse analytics with Apache Spark and Iceberg, AI data pre-processing, and AI model training and inference.

“Until now, use of S3 Express has typically been reserved for data that requires high speed access at the expense of enterprise features like replication and lifecycle management, due to its cost premium over S3 Standard,” said Garima Kapoor, co-founder and co-CEO, MinIO. “We’re changing that because we believe it can and should become the standard API for all analytical data and AI workloads. With the AIStor S3 Express API, pricing remains the same so enterprises can now put all of their analytical and AI data, not just a subset, in ‘express mode.’ This is drawing tremendous excitement from customers.”

“In most lakehouse environments, versioning is already handled by table formats like Apache Iceberg, which provide atomic operations at the file or table level,” said Sanjeev Mohan, principal analyst at SanjMo. “But when versioning is also enabled at the storage layer, it can create unnecessary duplication and complexity. Removing it from the storage layer simplifies the backend architecture, lowers CPU usage on storage servers, and helps prevent accidental storage growth and rising costs.”

AIStor’s S3 Express API support comes at no extra cost, without any request charges for GETs, PUTs and LISTs, and with key data protection and replication capabilities so it can be used for all enterprise analytical and AI data. Key features and benefits of the AIStor S3 Express API include:

  • Accelerated PUT and LIST operations: delivers up to 20% faster PUT operations, lowering CPU utilization, and up to 447% faster time-to-first-byte (TTFB) LIST operations relative to AIStor general purpose S3 API. This means faster training, faster analytics, and better infrastructure utilization.
  • New atomic, exclusive append operations: enables direct and safe object modification, eliminating multi-step update workflows. For example, media-broadcasting applications which add new video segments to video files can do so as they are transcoded and immediately streamed to viewers.
  • Full active/passive, disaster recovery (DR), and batch replication support: provides full performance benefits of the S3 Express API without loss of business continuity and disaster recovery (BC/DR). Synchronous replication means no data loss in the event of an outage and asynchronous replication enables data protection across the globe.
  • Streamlined and simplified API behavior: eliminates redundancies and implements simplifications and guardrails to improve the developer experience as well as application resiliency, predictability and security.

As the first and only on-premises and private cloud AI storage platform to adopt Amazon’s S3 Express API, MinIO is reinforcing its ongoing commitment to providing full and complete S3 API compatibility. To learn more about the AIStor S3 Express API, including the “how” and “why” behind specific features, please visit: https://blog.min.io/s3-express-api-added-to-aistor/. To book a demo, please visit min.io.

About MinIO
MinIO is the leader in high-performance object storage for AI. With 2B+ Docker downloads 50k+ stars on GitHub, MinIO is used by more than half of the Fortune 500 to achieve performance at scale at a fraction of the cost compared to the public cloud providers. MinIO AIStor is uniquely designed to meet the flexibility and exascale requirements of AI, empowering organizations to fully capitalize on existing AI investments and address emerging infrastructure challenges while delivering continuous business value. Founded in November 2014 by industry visionaries AB Periasamy and Garima Kapoor, MinIO is the world’s fastest growing object store.

Media Contact: Tucker Hallowell, Inkhouse, minio@inkhouse.com

ONEISALL MAKES ITS PROFESSIONAL GROOMING DEBUT WITH THE GRANDMASTER PRO CLIPPER

Brand’s First Pro-Grade Tool Designed for Working Groomers Who Demand Power, Precision, and Reliability

CHINO, Calif., May 29, 2025 /PRNewswire/ — After earning the trust of millions of pet parents with its popular at-home grooming tools, OneIsAll is stepping into the professional grooming arena for the first time with the launch of the Grandmaster Pro Professional Pet Clipper. Purpose-built for professional groomers and set to become the most efficient professional pet clippers on the market. This all-new clipper delivers the speed, durability, and performance required in high-volume grooming environments, without sacrificing the user-friendly design the brand is known for.

OneIsAll Grandmaster Pro 1
OneIsAll Grandmaster Pro 1

The Grandmaster Pro marks a major milestone for OneIsAll as it expands beyond the consumer space and enters the professional grooming market with a product developed specifically for working groomers. Designed in collaboration with grooming professionals, the clipper addresses key challenges of daily shop life: mat handling, grooming fatigue, battery downtime, and tool compatibility.

Key Features Tailored for Grooming Pros:

  • Up to 60% Faster Grooming Time
    High-performance blades provide ultra-smooth cutting with no snags or tugs, even on thick, curly, or matted coats, allowing groomers to complete trims in as little as 10-30 minutes per pet.
  • Nonstop Power with Swappable Battery System
    Comes with two high-capacity, rechargeable batteries and a swappable design that delivers up to 90 minutes of cordless runtime per charge.
  • Quiet, Low-Vibration Operation
    Noise and vibration-reduction technology create a calmer experience for anxious dogs while helping groomers maintain focus and control, particularly important in busy salons or mobile units.
  • Universal Blade Compatibility
    The durable steel blade reduces the need for frequent replacements and is compatible with standard blades, giving professionals the flexibility to use their preferred setup.
  • Ergonomic, Pro-Ready Build
    Lightweight, balanced design minimizes hand fatigue during long grooming sessions. Built for durability and comfort, even in high-volume shops.

“We’ve spent years perfecting grooming tools for pet parents at home, and now, we’re excited to bring that same commitment to simplicity and performance to the professional world,” said Terry Zhang, Founder and CEO of OneIsAll. “Our research revealed a significant demand and gap in the professional grooming market, highlighting key pain points for groomers. We saw an opportunity to apply our innovation and expertise to solve these challenges, leading to the development of the Grandmaster Pro. This product represents our first step into the professional grooming category, which has been engineered from the ground up to meet the needs of groomers who work with dogs all day, every day.”

The OneIsAll Grandmaster Pro Professional Pet Clipper is available now on Amazon and OneIsAll.com, starting at $129.99. The complete kit includes the clipper, two rechargeable batteries, multiple guide combs, and maintenance tools.

For more information, visit www.OneIsAll.com or follow @OneIsAll_official on social media.

About OneIsAll

OneIsAll is dedicated to “Transform How You Pet”, blending innovation with everyday practicality to improve the lives of pets and their people. From professional-grade grooming tools to smart feeding solutions and most recently tools for groomers. OneIsAll brings innovative technology and thoughtful design together to improve pet care routines worldwide. OneIsAll is proud to be honored with a CES 2025 TWICE Picks Award for their Comfy C1 Cordless Pet Grooming Vacuum Kit and sponsor the National Dog Show, celebrating the incredible bond between humans and their canine companions. Learn more at www.OneIsAll.com or follow @OneIsAll_official on Instagram and Facebook.

Lufax Announces Extraordinary General Meeting on June 25, 2025

SHANGHAI, May 29, 2025 /PRNewswire/ — Lufax Holding Ltd (“Lufax” or the “Company”) (NYSE: LU and HKEX: 6623), a leading financial services enabler for small business owners in China, today announced  that it will hold an extraordinary general meeting of the Company’s shareholders (the “EGM”) at 10:00 A.M. Hong Kong time on June 25, 2025 at Room 3601, No. 1333 Lujiazui Ring Road, Pudong New District, Shanghai, the People’s Republic of China, for the purposes of considering and, if thought fit, passing each of the proposed resolutions set forth in the EGM notice. The EGM notice, the EGM circular, and the form of proxy for the EGM are available on the Company’s website at https://ir.lufaxholding.com.

Holders of record of the Company’s ordinary shares on the Company’s register of members as of the close of business on May 9, 2025 (Hong Kong time) are entitled to attend the EGM in person. Holders of the Company’s American depositary shares (the “ADSs”) as of the close of business on May 9, 2025 (New York time), who wish to exercise their voting rights for the underlying ordinary shares, can submit their voting instructions to Citibank, N.A.

About Lufax

Lufax is a leading financial services enabler for small business owners in China. Lufax offers financing products designed to address the needs of small business owners and others. In doing so, Lufax has established relationships with 85 financial institutions in China as funding partners, many of which have worked with Lufax for over three years.

Investor Relations Contact

Lufax Holding Ltd
Email: Investor_Relations@lu.com 

ICR, LLC
Robin Yang
Tel: +1 (646) 308-0546
Email: lufax.ir@icrinc.com

NYSE Content Advisory: Pre-Market update + Nvidia, Salesforce beat on earnings

NEW YORK, May 29, 2025 /PRNewswire/ — The New York Stock Exchange (NYSE) provides a daily pre-market update directly from the NYSE Trading Floor. Access today’s NYSE Pre-market update for market insights before trading begins. 

Kristen Scholer delivers the pre-market update on May 29th

  • Stocks are rising Thursday after a federal court blocked President Trump’s reciprocal tariffs. Wednesday night, the U.S. Court of International Trade ruled that President Trump exceeded his authority when he enacted the tariffs.
  • Nvidia shares popped 5% in extended trading after the company beat earnings and sales estimates. Its data center business rose 73% from a year ago.
  • Salesforce (NYSE: CRM) exceeded earnings expectations and raised its guidance after reporting results. The company said it has agreed to pay $8 billion for data management software maker Informatica.

Opening Bell
First Eagle celebrates the launch of the FEGE & FEOE ETFs

Closing Bell
Xponential Fitness (NYSE: XPOF) celebrates its 2025 Analyst & Investor Fay

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State Grid Gansu Linxia Power Supply Company: Special inspection of charging piles to safeguard green travel

LINXIA, China, May 29, 2025 /PRNewswire/ — Since May, Linxia Prefecture in Gansu Province, as a characteristic tourist destination in the northwest, has experienced a peak in tourist flow. In order to ensure the charging needs of new energy vehicles, on May 28, the State Grid Linxia Power Supply Company organized staff to conduct special inspections of the charging stations at the Guanghe County passenger station and the charging area at the Buyexiang service area, fully ensuring the smooth operation of green travel.

With the increasing popularity of attractions such as Linxia Prefecture’s tourism style line, Songmingyan, and Taizi Mountain, the number of self-driving tourists has surged, leading to a significant increase in charging demand. In response, the State Grid Linxia Power Supply Company has conducted a comprehensive inspection of key parts such as the charging pile wiring, charging gun interface, and display screen to eliminate potential hazards such as equipment overheating and aging lines, ensuring the efficient and stable operation of the charging piles.

In recent years, Linxia Prefecture has relied on its natural scenery and cultural landscapes to create a distinctive tourism brand. To this end, the State Grid Linxia Power Supply Company has optimized the distribution lines of charging stations in advance, upgraded the capacity of transformers, and used a digital monitoring platform to monitor the load of charging piles in real time, ensuring the safe and stable power supply of charging stations.