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Yanolja Collaborates with OpenAI to Accelerate AI Adoption in the Global Travel Industry

Yanolja participating in travel vertical for the global launch of OpenAI’s agent “Operator” research preview

By working together with global leaders in AI solutions, Yanolja aims to deliver hyper-personalized experiences to global users throughout their entire travel journey

NEW YORK, March 5, 2025 /PRNewswire/ — Yanolja, a global travel technology company, announced its participation in Open AI’s global launch of its Operator research preview. This announcement marks another major step forward in Yanolja’s mission to revolutionize the global travel industry with travel-specific generative AI services based on its own proprietary data and infrastructure.

Operator is an AI agent developed by OpenAI that can go to the web to perform tasks such as inputting, clicking, and scrolling, managing travel bookings and online shopping in a web browser. Operator helps users complete travel bookings and shop online within a browser, and is able to click, scroll and type on its own. 

Initially launched in the U.S. in January, Operator’s research preview has now expanded to more global markets. Yanolja plans to support the enhancement of its services with insights gained from travel-related cases collected during the research preview phase.

“Through our extensive data related to travel, our generative AI can deliver hyper-personalized experiences throughout every stage of a user’s travel journey, enhancing satisfaction and loyalty,” said Jeff Kim, CEO at Yanolja Cloud. “Additionally, our AI technology will streamline customer service and automate operational processes for travel enterprises, leading to increased efficiency and convenience. We’re committed to accelerating the era of fully automated, personal and AI-driven total travel services, and look forward to our collaboration with OpenAI on enhancing the future of travel.”

Yanolja has been rapidly advancing the development of its AI capabilities. From the initial planning stages, it helps users automatically generate travel itineraries tailored to individual preferences and match the real-time inventory data such as room availability or dynamic price. During the trip, its AI services offer conveniences such as auto check-in/check-out with cloud-based kiosks, AI concierge services, and local restaurant recommendations, etc.

As one of the fastest-growing global travel technology companies, Yanolja has achieved remarkable growth, reaching total transaction volume of $19.8 billion in 2024 with 186% growth rate, while operating in 206 countries and connecting 1.33 million hotels with over 20,000 travel sales channels like online booking platforms or tour operators. This reflects its expanding global footprint and technological leadership.

Through collaborations with global AI leaders, Yanolja continues to drive digital transformation in travel, shaping the future of automated and intelligent travel experiences for both users and travel enterprises worldwide.

About Yanolja

Yanolja co., Ltd. is a leading global travel technology company leveraging AI to transform the travel industry for both travelers and travel enterprises. Built on the vision to create technology that connects people to their unique travel dreams, Yanolja delivers personalized travel experiences for travelers and uncovers operational efficiencies for travel enterprises through its innovative technology solutions and proprietary data infrastructure. Operating in more than 200 countries worldwide, Yanolja provides integrated transaction, subscription and data solutions that are redefining the future of travel and hospitality. Follow us on LinkedIn and visit our website to learn more.

Media Contact
Christina Kim
Corporate Public Relations Manager
(206) 245-7392
christina.kim@yanolja.com 

Newly-formed Archerfish Precision Diagnostics Pte Ltd: Ushers a New Era in Advanced Diagnostics

SINGAPORE, March 5, 2025 /PRNewswire/ — In a significant development for the clinical diagnostics landscape in Singapore, Angsana Molecular & Diagnostics Laboratory (Angsana) and Pathnova Laboratories (Pathnova) have announced their merger to form Archerfish Precision Diagnostics Private Limited (Archerfish). This strategic union brings together two leading laboratory players with complementary expertise – Angsana in molecular diagnostics and Pathnova in serology and AI – This merger positions Archerfish as a powerhouse in advanced diagnostic solutions.

In picture: From left: Dr Ian Cheong, Mr Peter Chia, Dr Chris Tan, Mr Kevin Lee
In picture: From left: Dr Ian Cheong, Mr Peter Chia, Dr Chris Tan, Mr Kevin Lee

The merger seeks to combine the unique strengths of both laboratories, expanding their capabilities beyond their current portfolio to offer a comprehensive range of advanced diagnostic assays.

Angsana is a pioneer in the field of molecular oncology in Asia, having introduced clinical Next-Generation Sequencing (NGS) early on. They have a strong track record of successful commercialisation and bringing clinical diagnostics tests to the market. Pathnova specialises in the development and manufacturing of diagnostic products, including the creation of intellectual property related to novel diagnostic technologies, exemplified by their proprietary early screening test for nasopharyngeal cancer. Both labs are focused on diseases prevalent in Asia.

Archerfish will cater to both the private and public healthcare sectors, enhancing access to innovative and accurate diagnostic services.

Advancing Diagnostic Innovation

Archerfish’s vision is to be at the forefront of diagnostic innovation, providing accurate, timely, and comprehensive solutions for early cancer screening, as well as precision diagnostics guiding treatments for cancer and other diseases.

By leveraging cutting-edge technologies and pioneering research, the company is expanding its portfolio of diagnostic tests to drive innovation in clinical practice.

Next-Generation Sequencing

One key area of development is advancing Next-Generation Sequencing (NGS) beyond personalised cancer care to other areas including infectious disease detection. For instance, metagenomic NGS (mNGS) enables the comprehensive identification of microorganisms, offering the potential to detect a wide range of viral and bacterial infections from a single plasma sample within a clinically actionable timeframe.

Data-Driven Disease Detection

In addition, the company is developing data-driven approaches to disease detection through serum proteomics and serological profiling. Advances in aptamer technology now allow for the profiling of thousands of proteins in serum, providing a versatile and powerful tool for diverse diagnostic applications.

Artificial Intelligence

To maximize the potential of these data-driven methods, Archerfish is integrating artificial intelligence to refine pattern analysis, improving disease detection and predictive accuracy. Through these innovations, the company remains committed to transforming diagnostics and enhancing patient outcomes.

The above contains forward-looking statements that are subjected to further technology and market research.

Strategic Leadership and Investment

Archerfish’s management team comprises leading clinicians, scientists and accomplished healthcare executives, providing the vision and leadership necessary for the company’s growth. Their combined expertise in diagnostics, research, and business strategy aims to keep Archerfish at the industry’s forefront in Asia.

The merger is backed by a consortium of strategic investors including Temasek Life Sciences Laboratory, The Life Sciences Innovation Fund, Temasek Life Sciences Accelerator and SEEDS Capital, which fund and support research and innovation. With such backing, Archerfish is well positioned to achieve its ambitious goals.

Collaborative Efforts and Future Plans

The formation of Archerfish is expected to facilitate greater collaboration in public-private partnerships, contributing to healthcare cost efficiency through economies of scale. By working closely with government agencies and healthcare providers, Archerfish aims to improve access to high-quality diagnostic services.

Archerfish is seeking to raise at least SGD$50 million over the next three years to support its expansion plans. This funding will be used to further develop and commercialise its innovative diagnostic solutions as well as regional expansion.

 “This merger represents a significant step forward in our mission to advance diagnostic science and improve patient outcomes,” said Dr. Lim Cheok Peng, Chairman of Archerfish Precision Diagnostics, Founder of Angsana Molecular & Diagnostics Laboratory

“Archerfish will address a critical gap in Singapore’s clinical laboratory landscape, seamlessly translating scientific evidence into practical, high-quality clinical laboratory solutions,” added Dr. Ian Cheong, Director of Archerfish Precision Diagnostics and Co-founder of PathNova Laboratories.

“The merger of these two laboratories fosters a dynamic synergy, uniting expertise and resources to drive groundbreaking innovation and create a greater positive impact on society,” said Mr Peter Chia, CEO of Temasek Lifesciences Laboratory.

About Archerfish Precision Diagnostics

Archerfish Precision Diagnostics Private Limited is a leading molecular diagnostics company dedicated to innovative solutions for cancer detection and treatment. Formed through the merger of Angsana Molecular & Diagnostics Laboratory and Pathnova Laboratories, both CAP-accredited laboratories, Archerfish combines excellence in clinical laboratory practice with a strong commitment to research and development.

Contact Information

Angeline Wong
Senior Strategic Development Manager
Angeline.wong@archerfishdx.com 

For more information, please visit our website: www.archerfishdx.com

2025 Call for Code Engages Developers to Build AI Solutions that Address Social and Humanitarian Issues

In its eighth year, Call for Code presents a series of SDG-focused hackathons throughout the year, kicking off with a competition to build AI agents

BOULDER, Colo., March 5, 2025 /PRNewswire/ — Today, Call for Code Creator David Clark Cause, Founding Partner IBM (NYSE: IBM), Global Impact Partner United Nations Human Rights, and Program Affiliate the Linux Foundation invite developers and problem solvers to participate in the 2025 Call for Code program to create projects and solutions that use AI to help tackle United Nations Sustainable Development Goals (SDGs)

IBM Corporation logo.
IBM Corporation logo.

Since its launch in 2018, Call for Code has rallied developers globally to come together and create innovative solutions to help solve the world’s largest problems with technology. In 2025, the Call for Code Global Challenge will again ask how AI can address humanitarian issues to make a real difference for communities around the world.

“Call for Code is a unique global tech initiative, that inspires and empowers developers and problem-solvers from around the world to use their talent to innovate for social good,” said David Clark, Founder and CEO of Call for Code. “I am immensely proud that Call for Code, alongside its founding partner IBM, and with UN Human Rights, has helped ensure that technology serves as a catalyst for sustainability, climate and humanitarian action.”

This year, participants will have the opportunity to take part in five qualifying hackathon events as part of the year-long Call for Code Global Challenge in collaboration with IBM’s TechXchange Client Advocacy team. For each event, teams will build an original proof-of-concept solution based on a different SDG with technologies like watsonx, IBM’s portfolio of AI products, and IBM Cloud services. Each hackathon will include a different theme linked to one of the 17 SDGs.

The first qualifying hackathon will be held March 20 through March 31, 2025. In honor of UN World Water Day on March 22, it calls on participants to build a proof-of-concept for an AI virtual agent using watsonx.ai that can be put to work to address an issue that falls under the SDG6: Clean Water and Sanitation. In addition, Call for Code will host a hackathon to tackle SDG 13: Climate Action as part of the 2025 Right Here, Right Now Global Climate Summit, the world’s largest human rights-based climate forum, hosted by UN Human Rights, the University of Oxford, and co-hosted by leading universities worldwide.

“From the very beginning, UN Human Rights has been honored to support Call for Code, recognizing that technology—when grounded in human rights—can be a powerful force for good,” said Ansar Mahfoudh, head of the Innovation and Analytics Hub at UN Human Rights. “Since helping launch this groundbreaking initiative almost a decade ago, we have supported those projects that champion innovation that serves humanity. We remain committed to ensuring Call for Code grows from strength to strength, by drawing on a community of socially-minded coders who place humans at the centre of tech and innovation solutions.”

“Call for Code is a unique opportunity to get hands-on with AI, build new skills, network with a community of like-minded problem solvers, and create solutions,” said Dinesh Nirmal, IBM Senior Vice President, IBM Software. “This year, there’s no-cost access to industry leading, enterprise-grade IBM software like watsonx.ai for participants. I am excited to see what teams build to make a positive difference.”

Teams, made up of one to five developers, can compete for prizes awarded in each hackathon. The top Call for Code solution from each qualifying hackathon will win $5,000 USD and one conference pass per team member to the IBM TechXchange Conference 2025 in Orlando. This is IBM’s biggest technical learning conference of the year (official rules apply, tickets are non-transferable, and travel and lodging are not included). The qualifying teams will also have the chance to advance to compete for the 2025 Call for Code Global Challenge Grand Prizes, including a top cash prize of $50,000 USD. Top teams will also have the opportunity for open-source project support from the Linux Foundation. Grand prize winners will be announced in December.

Interested participants can register here before March 18, 2025 for the first hackathon, which runs from March 20 to 31, 2025. More details about each Call for Code qualifying hackathon will be shared on the Call for Code website as the year progresses.

About Call for Code Global Challenge
Developers have revolutionized the way people live and interact with virtually everyone and everything. Where most people see challenges, developers see possibilities. That’s why David Clark, the CEO of David Clark Cause, created Call for Code in 2018, and launched it alongside Founding Partner IBM and Global Impact Partner United Nations Human Rights. In 2022 Call for Code was selected as the preferred innovation platform for the Right Here, Right Now Global Climate Alliance, the largest public/private initiative in the world promoting climate justice.

Contact:
Laura Gallardo
Laura.Gallardo1@ibm.com

EMFACE Surpasses 1 Million Treatments, Becoming the Fastest-Growing Non-Invasive Facial Lifting Procedure

PRAGUE, March 5, 2025 /PRNewswire/ — EMFACE, the revolutionary non-invasive facial treatment, has reached an extraordinary milestone—becoming the fastest procedure of its kind to surpass 1 million treatments worldwide in just under two years. This achievement cements EMFACE as the leading non-invasive facial procedure uniquely designed to treat both the skin and underlying muscles for a more youthful, lifted appearance.

Developed by BTL, a global leader in medical technology, EMFACE transformed the industry in 2022 as the first operator-independent procedure to non-invasively target facial muscles while simultaneously improving skin quality.

The ability to stimulate elevator muscles allows us to lift facial features from within—something that was never possible before with injectables or traditional energy-based devices,” said Dr. Yael Halaas, a facial plastic surgeon from NYC, USA.

With no needles, downtime, or discomfort, EMFACE has gained widespread recognition among both medical professionals and patients, driving its rapid adoption across the globe.

Innovation at the Forefront of Success

Over the past year, EMFACE has expanded its capabilities with the introduction of specialized submental and under-eye applicators, making the treatment even more versatile. The latest eye applicators received overwhelmingly positive feedback from attending medical experts upon their launch at the IMCAS World Conference in Paris in January 2025.

EMFACE isn’t just a procedure—it’s a facial multiplatform that allows us to treat different areas based on each patient’s unique needs. It’s a game-changer for anyone looking for natural-looking facial rejuvenation,” added Dr. Kyungkook Hong, a board-certified dermatologist from Seoul, Korea.

Global Expansion and Industry Impact

EMFACE continues to gain momentum, with more practitioners integrating it into their treatment offerings. Its ability to complement injectables makes it a key component of comprehensive facial rejuvenation plans, providing patients with non-invasive solution for enhanced results.

Reaching 1 million treatments in just two years is a testament to EMFACE’s groundbreaking technology and the value it brings to medical professionals,” said Tomas Schwarz, CEO of BTL. “We remain committed to expanding this platform and further advancing non-invasive facial treatments in the years ahead.”

For more information about EMFACE and its revolutionary technology, visit www.emface.com.

About BTL 
Founded in 1993, BTL has grown to become one of the world’s leading medical equipment manufacturers. With 500+ engineers and 3,000+ employees in over 80 countries, BTL offers advanced non-invasive solutions for body-shaping, skin-tightening, and other medical aesthetic treatments, including intimate health and mental wellness. Among other brands, BTL’s products include EMSCULPT NEO®, EMFACE®, EXION™ , EMSELLA®, EXOMIND™ as well as their proprietary HIFEM®, HIFES™ and EXOTMS™ procedures. Please visit www.btlaesthetics.com for additional information.

Media Contact: BTL@1milk2sugars.com

NYSE CONTENT ADVISORY: PRE-MARKET UPDATE FOR MARCH 5TH

NEW YORK, March 5, 2025 /PRNewswire/ — The New York Stock Exchange (NYSE) is proud to offer a daily pre-market update directly from the NYSE Trading Floor. Access today’s NYSE Pre-market update for market insights before trading begins. 

 

NYSE_March_5_Market_Update

Kristen Scholer delivers the pre-market update on March 5th

  • Investors parse through tariff developments ahead of Wednesday trading
  • Futures indicate a higher market open after Tuesday’s volatility
  • President Trump mentions that minor disruptions from levies are possible

Watch NYSE TV Live every weekday 9:00-10:00am ET 

 

NORTIV 8 Unveils GeoPilot Tactical Boot Collection

Unmatched and Versatile Men’s Tactical Footwear Built for Work, Adventure, and Everyday Excellence

NEW YORK, March 5, 2025 /PRNewswire/ — NORTIV 8, the leading brand in high-performance footwear, is proud to announce the launch of the GeoPilot Collection—a groundbreaking line of men’s tactical boots designed to meet the highest standards of durability, comfort, and versatility. Purposefully engineered for demanding professionals, outdoor adventurers, and those who rely on superior footwear in everyday life, the GeoPilot Collection combines cutting-edge technology with premium craftsmanship to deliver an unrivaled experience across any terrain.

NORTIV 8 proudly presents the GeoPilot Collection — a series of men’s tactical boots built for ultimate durability, comfort, performance, and versatility. These boots feature advanced technology and superior craftsmanship for peak performance across all terrains. Whether for hiking, work, or leisure, GeoPilot combines premium quality with unbeatable value.
NORTIV 8 proudly presents the GeoPilot Collection — a series of men’s tactical boots built for ultimate durability, comfort, performance, and versatility. These boots feature advanced technology and superior craftsmanship for peak performance across all terrains. Whether for hiking, work, or leisure, GeoPilot combines premium quality with unbeatable value.

The GeoPilot Collection features nine distinct models —Terrascope, Metrostrike, Peakforce, VaporGuard, DriftShield, HydroTrek, HydroArmorDesertstorm, and Paladin-Steel — each designed to meet specific needs. Combining superior protection, long-lasting comfort, and cutting-edge design, these boots are engineered for performance and adaptability across various activities, from hiking and work to leisure settings.

Terrascope: The All-Terrain Powerhouse

Terrascope is distinguished by its energy-returning ETPU sole, providing a lightweight, cushioned experience that reduces fatigue and supports every step. Designed to seamlessly adapt to both urban and rugged environments, its ETPU sole provides 50% more rebound and 33% less weight, ensuring superior energy return and enhanced comfort during extended wear. The wear-resistant Oxford upper is designed for durability while maintaining a stylish appearance, and the ASTM-certified slip-resistant rubber outsole ensures reliable footing on any surface, from wet city streets to rocky trails. Featuring an arch-supported insole for added comfort, Terrascope provides all-day support, and the convenient inside zipper allows for quick on and off, eliminating the hassle of laces. Whether you’re on your feet for work or exploring the outdoors, Terrascope offers the durability, comfort, and practicality you need.

Metrostrike: The Ultimate Tactical Boots for Maximum Performance

Metrostrike is crafted for all-day comfort, lasting durability, and versatile performance, making it perfect for demanding work environments. The responsive EVA midsole delivers superior cushioning and shock absorption, while ample arch support ensures fatigue-free wear, even through long shifts. Its lightweight yet durable construction offers the ideal balance of strength and comfort for extended use without weighing you down. With a unique heel design for added support, a contoured insole that cradles your arch, and a padded collar for ankle security, Metrostrike keeps you stable and supported throughout the day. The slip-resistant, high-traction rubber outsole provides reliable grip on any surface, enhancing safety in dynamic settings. Quick-access side zippers and pull loops offer effortless on/off, making it easy to get in and out during busy workdays. Combining tactical-grade performance with unbeatable value, Metrostrike delivers premium features and lasting quality without the premium price tag.

Peakforce: Built for Tough Environments, Crafted for Comfort

PeakForce is engineered for those who demand durability, protection, and all-day comfort in tough environments. Designed for prolonged wear, its thickened midsole absorbs impact, reducing strain during long shifts or intense activity. A lightweight build enhances mobility without compromising support, while a smooth inner zipper allows for quick, hassle-free wear. The reinforced upper, crafted from genuine leather and durable textiles, shields against rough conditions, with a gusseted tongue blocking out debris. For lasting comfort, a contoured heel cup insole provides arch support, complemented by high-rebound cushioning that keeps every step energized. Finished with a high-traction rubber outsole featuring slip-resistant grooves, PeakForce ensures a firm grip on unpredictable terrain, making it a reliable choice for any mission.

VaporGuard: Waterproof Protection for Extreme Conditions

The VaporGuard stands out with its exceptional waterproofing and reliable protection, designed for extreme conditions. Featuring a reinforced rubber toe cap, it provides impact resistance against debris and hazards, ensuring your toes stay safe. Its waterproof membrane offers 4-hour static water resistance, keeping feet dry even in wet environments. The leather and microsuede upper not only adds durability but also provides a sleek, flexible feel, combining both style and function. The advanced midsole, crafted from a combination of EVA and rubber, delivers optimal shock absorption for all-day comfort during outdoor activities. With an arch-supporting heel cup insole, the VaporGuard enhances stability and offers superior support, making it the perfect choice for rough terrain or long hours on your feet.

Elevate Your Performance with GeoPilot

The GeoPilot Collection is engineered for unmatched endurance, adaptability, and peak performance. Crafted with advanced technology and high-quality materials, each style offers all-day comfort, exceptional traction, and reliable protection on any terrain. Built for those who demand more, these boots combine tactical-grade durability, versatile design, and sleek style, empowering you to take on any challenge—whether at work, in the great outdoors, or during your daily routine.

Available Now

Experience the perfect blend of performance and style with the GeoPilot Collection. Explore the full range on NORTIV 8’s Amazon store, official website, and in selected retail stores. Unleash your potential with footwear designed to meet the demands of your daily challenges, offering a perfect balance of durability, comfort, and versatility. Discover the GeoPilot Collection today.

About NORTIV 8

NORTIV 8 is your ultimate destination for athleisure and outdoor footwear. Our footwear is designed to empower individuals to pursue their active lifestyles with confidence and comfort. With a focus on durability, functionality, affordability, and modern designs, NORTIV 8 empowers you to embrace your active lifestyle with style.

Global Industry Partners Jointly Release Net5.5G Best Practices & Deployment Guide Whitepaper

BARCELONA, Spain, March 5, 2025 /PRNewswire/ — At MWC Barcelona 2025, the Broadband Development Congress (BDC), hosted by the WBBA, was a resounding success. Themed “Smarter Broadband: Investment. Innovation. Intelligence,” the congress attracted over 200 industry leaders worldwide. Attendees exchanged views on key issues, including the Net5.5G evolution path, network technology innovation, and commercial practices.

Ryan Qiu, Vice President of Huawei's Data Communication Product Line, delivering a keynote speech titled
Ryan Qiu, Vice President of Huawei’s Data Communication Product Line, delivering a keynote speech titled “Accelerating Net5.5G Innovation with AI WAN, Striding to an Intelligent Era”

In his keynote speech at the congress, Ryan Qiu, Vice President of Huawei’s Data Communication Product Line, noted that the integration of AI into carriers’ strategies is gaining momentum, with Net5.5G serving as a catalyst for the in-depth convergence of networks and AI. To address this trend, Huawei has introduced AI WAN, a cutting-edge solution that comprehensively empowers IP networks in the Net5.5G era using AI. This solution enables carriers to unlock new network value across diverse scenarios, including individual, home, and enterprise settings.

At the congress, global industry leaders from organizations such as the WBBA, IPv6 Forum, ITU, and IETF reached a consensus during the “Fireside Chat: Forward-Looking Dialogue on the Evolution of Next-Gen Networks.” Net5.5G has now become an industry-wide consensus, making significant strides in areas including industry development, policy formulation, and commercial practices. The leaders called for enhanced industry collaboration and continued joint efforts to drive the commercial success of Net5.5G, thereby guiding the sustainable development of the Internet industry.

The WBBA, IPv6 Forum, ITU, IETF, and NIDA have collaborated to establish a next-generation network cooperation mechanism. While the WBBA and IPv6 Forum drive industry consensus, the ITU-T explores future network needs, the IETF spearheads the formulation of network technology standards, and the NIDA defines network construction standards and facilitates technology adoption.

The Global Net5.5G Pioneer Program has made steady progress. At the congress, industry leaders jointly released the latest progress of the program. To date, a number of outstanding Net5.5G pioneers have emerged globally, including 18 visionary pioneers, 2 region pioneers, and 18 business pioneers.

Multiple carriers shared their experience and achievements in Net5.5G commercial deployment. As an integrated operator in Spain, MasOrange builds an efficient capacity growth, ultimate experience and intent-based automation Net5.5G converged IP network. 400GE/800GE, SRv6 + slicing meet traffic surging and automatic network scheduling requirements, and support new services such as edge computing in the future. Based on Network Digital Map, through AI empowerment, MasOrange will stride to AN L4, a new phase of intelligent evolution. In addition, the WBBA has released the Net5.5G Best Practices & Deployment Guide Whitepaper, showcasing global Net5.5G best practices and providing valuable insights and inspiration for the industry.

As Net5.5G continues to evolve, the WBBA urges global industry organizations to strengthen industry cooperation and jointly drive industry innovation in technical standards, policies, and commercial practices to foster a thriving data communications ecosystem.

SECuRE trial update: 92% of pre-chemo participants experience greater than 35% drop in PSA levels across all cohorts. Cohort Expansion Phase commences.

HIGHLIGHTS

  • Safety Review Committee (SRC) meeting confirms end of the Dose Escalation Phase and commencement of the Cohort Expansion Phase (Phase II stage) of the SECuRE study.
  • Based on the efficacy and safety assessment of all cohorts and the focus on earlier stages of treatment, the SRC confirmed expansion at 8 GBq dose level and recommended to increase the number of cycles from up to 4 to up to 6.
  • Cohort 4 of the Dose Escalation Phase of the SECuRE trial, assessing multiple administrations of 67Cu-SAR-bisPSMA, is complete. Prostate-specific antigen (PSA) levels are continuing to drop in 3 participants, with reductions ≥80% observed in 3 cases so far. A complete response was achieved in a participant in cohort 4 following 2 doses of 12 GBq of 67Cu-SAR-bisPSMA to date, based on the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST).
  • Across all cohorts, 68% of participants have shown reductions in PSA levels, despite the vast majority of the participants (77%) only receiving a single dose of 67Cu-SAR-bisPSMA. The majority of participants that did not respond to the treatment had received chemotherapy in the metastatic castration-resistant prostate cancer (mCRPC) stage, were part of the lowest dose cohort (cohort 1) and had some of the highest PSA levels at study entry.
  • 67Cu-SAR-bisPSMA has shown a favourable safety profile across all cohorts. The majority of reported adverse events (AEs) were Grade 1-2, with anaemia and thrombocytopenia being the most prevalent among the haematological events. Most AEs have now resolved. One Dose Limiting Toxicity (DLT) in 1 participant occurred at the highest dose in cohort 4, a transient Grade 4 thrombocytopenia, which improved to Grade 3 after 2 weeks. This participant had bone metastases, a high baseline PSA [1503.12 ng/mL] and had previously been treated with chemotherapy and multiple lines of 177Lu-PSMA-617. A PSA drop of 10.7% was observed following the administration of 1 cycle of 67Cu-SAR-bisPSMA.  
  • In the group of 13 participants who had not received chemotherapy in the mCRPC setting, all but 1 participant had PSA drops of 35% or more, predominantly with single doses of 67Cu-SAR-bisPSMA. PSA reductions of 80% or more were achieved in almost half of these patients. The majority of participants had received ≥3 lines of therapy prior to enrollment in the study (63.6%). Disease control based on radiographic assessment (RECIST) was achieved in 11 of the 12 (92%) pre-chemotherapy participants who had evaluable disease at baseline.
  • The SECuRE trial protocol has been amended to bring 67Cu-SAR-bisPSMA to participants at earlier stages of their disease, in the pre-chemotherapy setting. The amendment incorporates an increase in the number of participants in the Cohort Expansion Phase of the trial from 14 to 24, with a subset of participants planned to receive the combination of 67Cu-SAR-bisPSMA with enzalutamide, an ARPi.

SYDNEY, March 5, 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 children and adults with cancer, is pleased to announce the completion of the Dose Escalation Phase of the SECuRE trial (NCT04868604)[1]. The SRC recommended the trial progress to the Cohort Expansion Phase (Phase II) at the 8 GBq of 67Cu-SAR-bisPSMA dose level based on the safety and efficacy data demonstrated in every cohort of the study.

Across cohorts 1-4 of the SECuRE study, 68% of participants have shown reductions in PSA levels, despite the vast majority of the participants (77%) only receiving a single dose of 67Cu-SAR-bisPSMA. Most of these participants had a high level of bone metastases at study entry (77.3%), a high median PSA of 112.86 ng/mL (range 0.1-1503.1) and were heavily pre-treated with ≥3 lines of therapy (63.6%). Disease control based on radiographic assessment (complete response + partial response + stable disease) was achieved in 78% of the participants so far (including 2 partial responses and 1 complete response observed to date based on the RECIST assessment). The complete response was seen in a patient dosed twice at 12 GBq. This is the second complete response recorded following 67Cu-SAR-bisPSMA treatment, first being the patient previously reported to have a complete response following 2 doses at 8 GBq (first dose administered through the SECuRE trial, and a second dose administered under the the United States [US] Food and Drug Administration [FDA] Expanded Access Program [EAP]).

Safety profile of 67Cu-SAR-bisPSMA is favourable across cohorts 1-4 with the majority of AEs being Grade 1-2. Anaemia and thrombocytopenia were the most prevalent AEs among the haematological events. No overall trends in other haematological parameters or renal safety were observed in any of the cohorts. Only 1 DLT has been reported in the trial (transient Grade 4 thrombocytopenia, which improved to Grade 3 after 2 weeks) in a patient in the highest dose cohort (cohort 4). This participant had a baseline PSA of 1503.12 ng/mL, had been treated with multiple lines of therapy, including chemotherapy in the mCRPC setting and multiple doses of 177Lu-PSMA-617, and had bone metastases prior to entering the study. The participant’s baseline characteristics may have contributed to the lowering of the platelet levels. Despite the unfavourable prognosis of this participant, which included a very high PSA and being heavily pre-treated, 1 cycle of 67Cu-SAR-bisPSMA was still able to reduce his PSA by 10.7% (to 1341.80 ng/mL).

Pre-chemotherapy participants

Thirteen participants across cohorts 1-4 in the SECuRE trial were naïve to taxanes in the mCRPC setting (pre-chemotherapy), including 2 in cohort 1 and 3 in cohort 2. The majority of pre-chemotherapy participants had bone metastases (69.2%) with a median PSA of 42.41 ng/mL (range 0.1-182.4) at study entry. Almost half of these participants received ≥3 lines of therapy prior to trial enrolment (46.2%).

Despite the heavy disease burden and the majority of participants only receiving single doses of 67Cu-SAR-bisPSMA, there was an outstanding result observed in the pre-chemotherapy setting. Out of the total of 13 pre-chemotherapy participants across all cohorts, 12 had PSA drops greater than 35%. PSA reductions greater than 50% were reached in 61.5% (8/13) of participants, and reductions of 80% or more were achieved in 46.2% (6/13) of participants. Disease control based on the RECIST assessment was also observed in 11 out of 12 pre-chemotherapy participants (92%) who had measurable disease at baseline. One participant reached a complete response with 2 doses of 12 GBq in cohort 4, 2 participants had partial responses (cohort 2 and cohort 4), and 8 participants achieved stable disease at this time.

Three participants in the pre-chemotherapy setting of the SECuRE trial had previously been treated with actinium-225 based radioligand therapies (RLT) and, in 1 case, in combination with lutetium-177 based therapy. All 3 participants showed reductions in PSA levels following treatment with 67Cu-SAR-bisPSMA in the trial. Notably, 1 of these 3 participants showed a PSA reduction of 83.4% following the administration of 2 doses of 12 GBq of 67Cu-SAR-bisPSMA in cohort 4, despite being heavily pre-treated. The lines of therapy administered to the patient prior to the SECuRE trial enrollment included androgen deprivation therapy (ADT), 2 androgen receptor pathway inhibitors (ARPIs), autologous cellular immunotherapy, and investigational agents (immunotherapy and 177Lu-PSMA-I&T plus 225Ac-J591).

Safety assessment in pre-chemotherapy participants was comparable to the overall patient population with most AEs being Grade 1 and Grade 2.

Cohort Expansion Phase

Based on the data from cohorts 1-4, the SRC recommends the SECuRE trial progress to Cohort Expansion (Phase II) at an 8 GBq dose level, with an increase in the total number of cycles from up to 4 to up to 6. This recommendation is based on the favourable safety profile of 67Cu-SAR-bisPSMA observed to date.

Cohort 2 (single dose of 8 GBq of 67Cu-SAR-bisPSMA) with 3 participants had the highest rate of PSA response in the trial, and all participants in the cohort had disease control based on the RECIST assessment (including one partial response). The PSA reductions were 81.4%, 95.2% and 99.4%. Only 1 participant in this cohort developed 67Cu-SAR-bisPSMA-related AEs (Grade 1 dry mouth and altered taste, both improved, and Grade 2 fatigue, resolved). No haematological toxicity was reported in the cohort.

The first patient to receive 2 doses of 67Cu-SAR-bisPSMA at 8 GBq (first dose through the SECuRE trial and second dose under the US EAP) achieved a complete anatomical, molecular and biochemical response (assessed by the RECIST criteria, positron emission tomography [PET] and PSA, respectively). He had been heavily pre-treated (chemotherapy in the neoadjuvant setting, ADT, 2 ARPIs and an investigational agent) prior to entering the SECuRE study. The patient’s recent follow up showed that he remains with undetectable PSA for almost 16 months, having received his first dose of 67Cu-SAR-bisPSMA over 20 months ago (June 2023). A recent PSMA PET showed no signs of recurrent or metastatic disease. Most AEs related to 67Cu-SAR-bisPSMA were mild or moderate, with the majority having either improved or resolved over time.

Based on these safety and efficacy data, where exceptional efficacy signals were observed at lower radiation doses, 8 GBq was chosen as an optimal dose for the Cohort Expansion Phase.

The SECuRE trial protocol has been amended to include evaluation of mCRPC participants who have not received chemotherapy in the metastatic (pre-chemotherapy) setting. This amendment is aligned with Clarity’s strategy of bringing 67Cu-SAR-bisPSMA to participants with earlier stages of the disease and is based on the promising safety and efficacy data, especially in pre-chemotherapy participants of the SECuRE trial.

The protocol amendment also incorporates an increase in the number of participants in the Cohort Expansion Phase of the trial from 14 to 24, in which a subset of participants will receive the combination of 67Cu-SAR-bisPSMA with enzalutamide, an ARPI. These changes are aimed at optimising the development of all of Clarity’s products in prostate cancer, following ongoing discussions with and advice from many important global medical experts in the field of prostate cancer, including the Company’s Clinical Advisory Board members, Prof Louise Emmett and Prof Oliver Sartor, as well as the SRC.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, “The SECuRE trial continues to generate extraordinary results, and we thank our team, Principal Investigators, members of the SRC, and especially the participants who have contributed to the study. Seeing the safety profile and already observing impressive signs of efficacy (despite the majority of participants only receiving a single cycle of 67Cu-SAR-bisPSMA and the primary focus of the Dose Escalation Phase being safety assessments), we are thrilled to progress to Phase II, the Cohort Expansion Phase, of our theranostic SECuRE trial.

“Dose escalation trial design has not been routinely used in other RLT studies. By pioneering this approach with the SECuRE trial, Clarity was looking to systematically evaluate the safety of 67Cu-SAR-bisPSMA in the context of its therapeutic effect. By gradually increasing the dose from one cohort to the next, we have minimised the risk of AEs and established a favourable safety profile for patients, while also demonstrating that 67Cu-SAR-bisPSMA is effective.

“We are looking forward to executing our strategy of bringing 67Cu-SAR-bisPSMA to earlier lines of prostate cancer therapy with the recent protocol amendment, given the exciting data in pre-chemotherapy participants. We are also increasing the number of participants in the Cohort Expansion Phase. This decision is partly motivated by the increased demand from oncologists to include their participants into the trial, but it is also led by our decision to explore potential benefits of using a combination of 67Cu-SAR-bisPSMA with enzalutamide, following consultation with world-leading prostate cancer oncologists and nuclear medicine physicians.

“With our focus on treating earlier stage disease (pre-chemotherapy in the mCRPC setting), it is an incredible outcome to have 12 out of 13 pre-chemotherapy participants in the trial experiencing greater than 35% reductions in PSA and almost half of the 13 experiencing drops of 80% or greater. PSA reductions were seen across all cohorts, including the lowest 4 GBq cohort where all pre-chemotherapy participants exhibited greater than 50% drops in PSA from a single dose. Remarkably, one of those participants has had 4 additional doses under EAP and achieved disease control for over 2 years since first treatment. The results from 3 pre-chemotherapy participants who received 8 GBq of 67Cu-SAR-bisPSMA have been outstanding with a favourable safety profile and excellent efficacy, where PSA reductions were greater than 80% for all participants and above 95% for 2 out of the 3 participants, with all of them achieving radiographic disease control and 1 showing a complete response to date.

“The very compelling safety and efficacy data for SAR-bisPSMA that we continue generating stems from Clarity’s strong adherence to the highest level of scientific and clinical research. At the heart of this rigorous approach is the dimer “bis” molecule developed at the benchtop of Australian science and translated into the clinic. When optimising the PSMA molecule, the goal was to create an ideal candidate for both therapy and diagnosis of prostate cancer. We wanted to overcome the shortfalls of the current generation of PSMA-targeting products, increasing not only the amount of product in the lesions, but also how long the product is retained in the lesions over time. We are now seeing these results in the clinic with 67Cu-SAR-bisPSMA in the SECuRE trial and with 64Cu-SAR-bisPSMA in our diagnostic trials.

“The recent receipt of 3 Fast Track Designations from the US FDA for our optimised SAR-bisPSMA molecule, one of which was based off the data presented here, is testament to the high quality of this data, but also reflects a critical need for novel solutions in prostate cancer management. With an estimated combined market value of approximately US$10-15 billion by 2030 for PSMA-targeted products, we are hoping to address the evident high unmet need in this segment, from first diagnosis to the treatment of metastatic disease, and improve treatment outcomes for men with prostate cancer around the world.

“We look forward to swiftly recruiting into the next phase of the SECuRE trial, moving towards a Phase III pivotal trial. We are very excited about what the future holds for this promising product and are working tirelessly to bring it to people who need it most in a timely manner, whilst adhering to the highest standards of clinical research.”

About the SECuRE trial

The SECuRE trial (NCT04868604)[1] is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion involving approximately 54 participants in the US and Australia. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment 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.

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[2]. 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[3].

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 in children and adults.

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: NCT04868604, https://clinicaltrials.gov/ct2/show/NCT04868604
  2. Global Cancer Statistics 2022: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834
  3. 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.