Tuesday, June 30, 2026

Cartilage Tissue Engineering Heads to Orbit in NSF and NASA-supported Study at the International Space Station

 


SEATTLE - 

UC Irvine researchers use single cell RNA sequencing to study cartilage tissue engineered in microgravity


(BUSINESS WIRE) -- Researchers in the DELTAi Lab at the University of California, Irvine, working with NASA, are using Evercode Cell Fixation to preserve samples aboard the International Space Station as part of a study of cartilage tissue engineering in microgravity. The unprecedented work, part of a National Science Foundation (NSF)-funded grant led by Dr. Wendy Brown and Dr. Kyriacos Athanasiou, announced today by Parse Biosciences, aims to advance treatments for the hundreds of millions of people worldwide affected by cartilage injury.


Cartilage injuries cause significant pain and disability, and the need for implants that can repair or regenerate damaged tissue without harming a donor site has gone unmet for decades. Part of the difficulty is gravity itself, which may work against the formation of cartilage tissue in the lab. Microgravity may help get around that problem, and a growing line of research suggests that tissues engineered in orbit can come closer to the real thing than tissues engineered on the ground.


The researchers at UC Irvine first rejuvenate highly expanded chondrocytes to restore chondrogenic gene expression and the cells’ ability to produce cartilage. The cells are then allowed to self-assemble into neocartilage without a scaffold, and the tissue is matured under mechanical tension to build up its strength. All of this takes place in orbit in flight-certified hardware developed by BioServe Space Technologies at the University of Colorado Boulder, with samples taken for study at timepoints from the first hours of differentiation to nearly 30 days of neocartilage culture. The samples are preserved with Parse Biosciences' Evercode Cell Fixation and returned to Earth for single cell RNA sequencing.


According to Dr. Rachel Nordberg, who is leading the study to examine the rejuvenation of these cells, “The ability to study rejuvenation of our minipig cells in microgravity at the single cell level requires us to be able to effectively preserve the cells with a long storage timeframe. We also need a species-agnostic platform that has full functionality with our specialized animal model (the Yucatan minipig).” Dr. Wendy Brown added, “Parse offers the perfect solution to give us the flexibility we need to study minipig cells, collect samples at multiple timepoints, and handle the unpredictability of spaceflight operations.”


“What the UC Irvine team is doing is remarkable. Engineering cartilage in microgravity could fundamentally change how we think about tissue repair, and the fact that they are running this level of single cell work from samples preserved in orbit is a real testament to the rigor of their science. We are honored that Evercode is a small part of it,” said Charlie Roco, PhD, Co-founder and Chief Technology Officer at Parse Biosciences.


About Parse Biosciences


Parse Biosciences, a QIAGEN company, is a global life sciences company whose mission is to accelerate progress in human health and scientific research. Empowering researchers to perform single cell sequencing with unprecedented scale and ease, its pioneering approach has enabled groundbreaking discoveries in cancer treatment, tissue repair, stem cell therapy, kidney and liver disease, brain development, and the immune system.


 


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Contacts

Kaitie Kramer

kkramer@parsebiosciences.com | +1-858-504-0455


 

MANE Selects Kinaxis to Strengthen Global Planning Capabilities

 Kinaxis Maestro™ platform to provide the digital foundation to strengthen MANE’s global planning capabilities and support its continued planning transformation


(BUSINESS WIRE) -- Kinaxis® (TSX:KXS), a global leader in end-to-end supply chain planning and orchestration, today announced that MANE, one of the top five leading organizations worldwide in the flavours and fragrances industry, has selected Kinaxis to modernize its planning capabilities as it accelerates global growth as part of a broader enterprise-wide transformation initiative.


Headquartered in the south of France, with a significant global footprint spanning multiple regions and customers across international markets, MANE is known for its innovation, technical expertise and strong commitment to sustainability. The company is investing in more connected, end-to-end planning capabilities to support continued growth and increasing operational complexity worldwide.


Following an extensive evaluation process with major competitors in the market, MANE selected the Kinaxis Maestro platform for its proven ability to support complex, multi‑region planning environments with speed, transparency, and confidence. Unlike legacy systems that rely on static data and sequential processes, Maestro allows teams to instantly see the impact of change, run scenarios in real time, and make faster, more informed decisions.


“Kinaxis offered the modern architecture and flexibility we were looking for to support our rapid transformation,” said Scott Quinn, ERP Program Director at MANE. “We needed an AI-driven solution that could scale alongside our global footprint, support our teams across regions, and provide a single, reliable view of demand as we continue to grow.”


With Maestro, MANE will gain AI-powered demand planning built on a concurrent data model, enabling teams to instantly assess change and align demand decisions across functions while providing the foundation to replace static, fragmented planning processes with a more agile and responsive approach.”


“MANE’s rapid global expansion brings a new level of planning complexity, from sourcing natural raw materials and managing increasingly interconnected supply networks to meeting the needs of customers across diverse regional markets,” said Mark Morgan, President of Global Commercial Operations at Kinaxis. “Navigating this level of complexity requires a fundamentally different approach to planning, and MANE is demonstrating that kind of forward-thinking leadership having selected Kinaxis to provide the orchestration capabilities needed to support their next phase of growth. With Maestro as their foundation, MANE will be better positioned to anticipate change, align decisions across the business and scale with confidence. We’re excited to support them in this next chapter.”


MANE is taking a phased approach to its supply chain transformation with the initial deployment focused on demand planning and future expansion of Maestro anticipated as the company continues to scale. To learn more about Kinaxis and its industry‑leading supply chain orchestration platform visit www.kinaxis.com.


About Kinaxis


Kinaxis is a leader in modern supply chain planning and orchestration, powering complex global supply chains, and supporting the people who manage them. Our powerful, AI-infused supply chain orchestration platform, Maestro, combines proprietary technologies and techniques that provide full transparency and agility across the entire supply chain — from multi-year strategic planning to last-mile delivery. We are trusted by renowned global brands to provide the agility and predictability needed to navigate today’s volatility and disruption. For more news and information, please visit kinaxis.com or follow us on LinkedIn.


Source: Kinaxis Inc.


 


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Contacts

Media Relations

Erin Boyle | Kinaxis

eboyle@kinaxis.com

+1 519-574-4065


Investor Relations

Victoria Hyde-Dunn | Kinaxis

vhyde-dunn@kinaxis.com

Esri Sponsors Smithsonian Exhibition Showcasing Natural and Cultural Objects from All 50 States


 REDLANDS, Calif. - 

From These Lands Exhibition Highlights Connections Between People, Place, and Natural World Through Physical Specimens and Digital Maps


Esri is the lead sponsor of the Smithsonian's From These Lands exhibition and developed maps powered by ArcGIS and a digital companion to extend engagement beyond the museum.

The exhibition features more than 600 specimens and cultural artifacts from all 50 states, Washington, DC, and US territories, drawn from the Smithsonian's National Museum of Natural History's collection of over 148 million objects.

Designed around themes of connection, diversity, and discovery, the exhibit explores how landscapes, ecosystems, and cultural traditions shape one another across regions and time.

Animated mapping experiences enable visitors to explore topography, biomes, geology, migration patterns, and watersheds, revealing relationships across the continent.

ArcGIS StoryMaps transforms the physical exhibit into an accessible digital narrative, extending its reach to educators, students, and global audiences.

 


(BUSINESS WIRE) -- Esri, the global leader in location intelligence, is sponsoring From These Lands: Sharing Our Natural and Cultural Heritage, a new exhibition at the Smithsonian's National Museum of Natural History that showcases objects from all 50 states and explores the deep connections between people, place, and the natural world that unite the nation.


The exhibit, which opened this June 18 and runs through 2029, brings together more than 600 specimens and cultural artifacts from across the United States, Washington, DC, and the five territories that people call home. Drawing from the museum's own collection, From These Lands shows how natural systems, cultural traditions, and geography intersect.


The exhibition presents stories that span millions of years—from ancient fossils and geological formations to cultural artifacts and scientific breakthroughs—inviting visitors to reflect on their own sense of place. By pairing natural specimens with cultural objects, From These Lands demonstrates how human cultures are both shaped by and actively shape the natural world.


Esri's technology plays a central role in bringing these themes to life. Animated maps within the gallery allow visitors to explore North America through geographic lenses such as topography, biomes, geology, migration routes, and watersheds, helping reveal patterns and relationships across landscapes.


The Smithsonian collaborated with Esri to create a companion story that extends the new exhibition into a dynamic digital experience. The ArcGIS StoryMaps story integrates maps, multimedia, and narrative content to connect objects and stories across locations, effectively transforming the exhibit into a living, interactive resource that can be accessed from anywhere.


"We are honored and thrilled to make this contribution to such an enriching exhibit at the Smithsonian showcasing the nation's natural history," said Jack Dangermond, Esri president. "The immersive experience of the museum's artifacts and animated maps emphasize how our shared geography connects us even across great distances and boundaries."


Visitors can experience From These Lands: Sharing Our Natural and Cultural Heritage at the Smithsonian's National Museum of Natural History in Washington, DC, and explore the story online.


About Esri


Esri, the global market leader in geographic information system (GIS) software, location intelligence, and mapping, helps customers unlock the full potential of data to improve operational and business results. Founded in 1969 in Redlands, California, USA, Esri software is deployed in hundreds of thousands of organizations globally, including Fortune 500 companies, government agencies, nonprofit institutions, and universities. Esri has regional offices, international distributors, and partners providing local support in over 100 countries on six continents. With its pioneering commitment to geospatial technology and analytics, Esri engineers the most innovative solutions that leverage a geographic approach to solving some of the world's most complex problems by placing them in the crucial context of location. Visit us at esri.com.


Copyright © 2026 Esri. All rights reserved. Esri, the Esri Globe logo, ArcGIS, The Science of Where, esri.com, and @esri.com are trademarks, service marks, or registered marks of Esri in the United States, the European Union, or certain other jurisdictions. Other companies and products or services mentioned herein may be trademarks, service marks, or registered marks of their respective mark owners.


 


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Contacts

media.help@esri.com

Geoswift and SKUx Announce Strategic Partnership to Develop a First-of-Its-Kind Programmable Stablecoin Commerce Network


 VANCOUVER, British Columbia & ST. PETERSBURG, Fla. 

Bridging digital assets, traditional finance, enterprise treasury, and agentic commerce through global programmable money infrastructure


 


(BUSINESS WIRE)--Geoswift and SKUx announced a groundbreaking partnership to develop a next-generation programmable stablecoin commerce network. This strategic collaboration bridges digital assets, traditional finance, and real-world commerce at a global scale, representing a "one-of-one" opportunity by combining Geoswift's global infrastructure with SKUx's specialized item-level controls directly within point-of-sale (POS) systems.


While enterprise stablecoin usage continues to accelerate globally, governments, enterprises, payment networks, and AI-driven commerce platforms are increasingly seeking programmable payment infrastructure that can bridge digital assets with real-world commerce. The innovation goes far beyond treasury management or even enabling consumers to spend stablecoins at retail locations. Instead, it unlocks true "programmable money" with embedded controls, rules, and purpose-driven utility —requiring both programmable settlement and programmable spending controls. Geoswift and SKUx are uniquely positioned to achieve this by pairing Geoswift’s global payment network, stablecoin settlement capabilities, liquidity support, and compliance infrastructure with SKUx’s multi-patented offers platform and extensive item-level partner network.


Global Infrastructure and Enhanced Merchant Compliance. Designed to be adaptable to any retailer environment, SKUx’s SKUPay® technology is already embedded in an estimated 50% of major U.S. grocery and big-box point-of-sale systems, unlocking a significant new category of merchant payment infrastructure. While the initial launch is U.S.-focused, the partnership builds on Geoswift’s proven global network and cross-border scale, following its recent integrations with Visa Direct and the Circle Payments Network. Spanning 140+ countries and 110+ payout currencies, Geoswift's footprint enables seamless international expansion and robust transaction compliance. Through its global banking and payment infrastructure, Geoswift processes cross-border transactions for enterprises, financial institutions, education providers, e-commerce platforms, and global merchants. By merging item-level payment precision with global stablecoin settlement transparency, the network opens entirely new programmable applications across retail, healthcare, government benefits, and cross-border commerce.


Beyond these commerce use cases, the network will also enable enterprise treasury programs that leverage stablecoin infrastructure to improve liquidity management, settlement efficiency, and working capital utilization.


Guardrails for Agentic Commerce. As the landscape shifts toward AI-driven agentic commerce—where autonomous AI agents execute financial workflows—securing the merchant control layer is paramount. While global payment networks are actively building authorization and settlement layers, a critical gap remains in validating exactly “what” automated agents are purchasing. This partnership solves that gap, delivering the specific item-level guardrails required to accept automated, programmable purchases securely and transparently.


"Stablecoins have solved for programmable settlement. SKUx and Geoswift are now solving for programmable spending," said Raymond Qu, Group CEO and founder of Geoswift. "Together, we are creating the infrastructure that enables digital assets, AI agents, enterprises, and consumers to transact securely in the real economy at global scale."


"By anchoring Geoswift's global liquidity and compliance engine directly into our platform infrastructure, we are transforming how the world views digital assets at the point of sale," said Bobby Tinsley, CEO and co-founder of SKUx. "This isn't just about enabling payments—it's about bringing unprecedented item-level intelligence and security to the next generation of global commerce, including the rapidly emerging world of autonomous AI agents."


The long-term vision of the partnership is to enable purpose-bound digital money that can be programmed with rules, spending controls, compliance requirements, and settlement instructions across global commerce networks.


About Geoswift


Geoswift is an innovative global payment technology company specializing in APAC cross-border payments. Since its founding in 2010, the Geoswift brand has become synonymous with proprietary innovation, deep expertise in international and local regulatory frameworks, robust banking partnerships, and a strong global presence. Licensed in the United States, United Kingdom, and Hong Kong SAR—and supported by an extensive payment network spanning APAC, North America, EMEA and Latin America—Geoswift provides customized, end-to-end cross-border payment solutions for a broad spectrum of industries, including education, e-commerce, travel, and financial services.


Its comprehensive product suite includes payment acceptance, business payouts, foreign exchange, multi-currency business accounts, card solutions, and more. Headquartered in Vancouver, Canada, Geoswift has regional offices in Hong Kong, San Francisco, London and Singapore—offering seamless, localized payment solutions to clients across the globe. For more information, visit geoswift.com.


About SKUx


SKUx provides a purpose-driven network that combines easy mobile wallet delivery with granular transaction controls. Their platform allows brands to bypass legacy coupon systems and replace them with secure, digital payments that can be restricted by merchant category, location and all the way down to the SKU-level. This item-level precision helps eliminate fraud and waste while providing brands with 360-degree visibility into how funds are used in real-time. For more information, visit skux.io.


 


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Contacts

 

Media Contact:

Brenda Ng

Geoswift Media Contact

Brenda.ng@geoswift.com


Reva Henderson

SKUx Media Contact

Will Marlow Agency

+1 727-580-1910

reva@willmarlow.com


 

Monday, June 29, 2026

The Premier Jumping League (PJL) & McCarthy Jumping Team Announce Landmark Purchase

 With $50 Million Team Acquisition, McCarthy Jumping Team Becomes First PJL Ownership Group


Acquisition illustrates strong investor confidence in the future of professional showjumping as highly anticipated 2027 inaugural season to feature 16 teams competing across 14 international events

(BUSINESS WIRE) -- The Premier Jumping League (PJL) today announced that seasoned trader, investor, and competitive race car driver Jason McCarthy and McCarthy Jumping League LLC acquired the first PJL team in a landmark $50 million acquisition, building on rising momentum for the highly acclaimed professional jumping league.

The milestone investment represents an unprecedented valuation for a team in a newly established sports competition and underscores the confidence that sophisticated investors are placing in the PJL.

The inaugural PJL season is scheduled to commence in April 2027.

McCarthy brings extensive investment and trading experience to the League, having held leadership positions across the financial sector throughout his career. A graduate of MIT, McCarthy is the Founder and Managing Principal of a proprietary trading firm active across a diverse range of domestic and international markets. He, his wife, Newsha, and their daughter, Natalia, share a deep passion for horses, owning equine farms in Watermill, NY and Wellington, FL. Natalia is a junior competitive rider who aspires to one day compete at the highest level of jumping.

The McCarthy Jumping Team acquisition reflects confidence in McCourt Global’s $300 million prize money commitment, and in the long-term vision, business model, and financial viability of the PJL. Through a disciplined focus on expanding the commercial potential of jumping, the PJL is establishing itself as an investable sports property, with a clear pathway to long-term asset appreciation.

Commenting on the investment, McCarthy said: “Like Frank McCourt, our family's journey into this sport began with my wife, Newsha, whose lifelong love of horses first introduced us to the equestrian world. Through her passion, we became fans of jumping and developed a deep appreciation for the extraordinary partnership between horse and rider.

We believe strongly in the PJL’s vision – a league committed to the highest ethical standards, meritocracy, and elite competition, underpinned by a sustainable commercial model that attracts the world’s best riders and delivers fan experiences on par with the greatest global sporting competitions.

We see enormous potential for the sport to grow its global audience while remaining true to the values that make it so special. We are confident the PJL will help realise that potential and drive meaningful growth for the sport we have come to love.”

Executive Chairman of McCourt Global, Frank McCourt, added: “This investment is a powerful endorsement of the PJL’s vision and the future potential of jumping. From the outset, our ambition has been to attract new capital and new growth opportunities to the sport. Jason and his family embody the values and ethos we aim to uphold within the League, and we are delighted to welcome McCarthy Jumping Team as the PJL’s first ownership group.”

About the Premier Jumping League (PJL)

The PJL is a groundbreaking global 16-team competition defining a new era for showjumping.

Backed by McCourt Global and its Executive Chairman Frank McCourt, and shaped by leaders from equestrian sport, international competition, and entertainment, the PJL brings together the world’s top riders and horses to compete for the biggest prize pot in the discipline’s history ($300M guaranteed prize money across the first three years), across fourteen iconic venues in North America, Europe, and the Middle East.

Designed to open the sport to new audiences whilst respecting its heritage, the PJL combines extraordinary athletic performance with premium entertainment, strengthened by the league’s partnership with Box to Box Films (the production company behind F1’s ‘Drive to Survive’), and supported by a free-to-view broadcasting model.

Cutting-edge technology, radical transparency, and innovative team formats enhance the drama, intensity, and rivalry that define elite sport – unlocking the full potential of jumping, demanded by today’s global sports and entertainment marketplace, without compromising its core values.

The PJL distinguishes itself through its commitment to the highest standards of horse and rider welfare.

The PJL continues to work closely with the FEI as the League progresses through the Series Approval process. A decision is expected imminently.

About the McCarthy Jumping Team

McCarthy Jumping Team is privately held by the McCarthy Family Office, which services the interests of the McCarthy family.

 

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Contacts
Kelly Hogarth | pressoffice@pjl.com | [+44 777 269 7805]
Follow The PJL:
Website: www.pjl.com
Substack: @thepjl
Instagram: @the_pjl_official

Mastercard launches Africa Cybersecurity Center of Excellence to help secure the continent's digital future

Johannesburg, South Africa - Monday, 29. June 2026 AETOSWire Print 


 

New pan-African initiative aimed at strengthening collective cyber resilience across Africa's digital economy
Brings together public and private sector organizations to share intelligence, build readiness and support improved response
Launch begins in South Africa and Nigeria, reinforcing Mastercard's long-term commitment and investments in Africa's digital transformation and supporting trust in the digital ecosystem
 

Mastercard announced the launch of its Africa Cybersecurity Center of Excellence, a pan-African initiative designed to strengthen cyber resilience, enhance collaboration and help safeguard the trust that underpins Africa's expanding digital economy.

The announcement was made during a visit to South Africa and Nigeria by Mastercard CEO, Michael Miebach, reflecting Mastercard's long-term commitment to supporting Africa's digital transformation by helping organizations anticipate, withstand and recover from increasingly sophisticated cyber threats. The Cybersecurity Center of Excellence extends Mastercard’s expertise and network, bringing global competence and intelligence to one of the world's fastest-growing digital economies.

This initiative follows through on commitments made in recent discussions with the Nigerian Government in Abuja, and the South African Government during last year’s G20 meetings in Johannesburg, to strengthen cybersecurity efforts in Africa.

His Excellency, Cyril Ramaphosa, President of South Africa, said: “We recognize that for digitization to be inclusive, it must be trusted and secure. Mastercard has long been a trusted partner to South Africa, and its Cybersecurity Centre of Excellence is a welcome step to build on that foundation, drawing on the country’s best and brightest to meet a challenge no government or company can solve alone."

His Excellency, Bola Ahmed Tinubu, GCFR, President of Nigeria, said: “As Nigeria deepens its digital transformation, secure and trusted systems will be critical to inclusion and growth. We welcome collaborations that strengthen our digital economy and build resilience for the future.”

As digital adoption accelerates across Africa, cybersecurity has become an imperative for economic growth. No single organization can face today’s cyber threats alone. The Africa Cybersecurity Center of Excellence has been established to support the strengthening of collective defense across the continent by bringing together financial institutions, public sector organizations and businesses to share intelligence, improve preparedness, anticipate threats earlier and build resilience over time.

Michael Miebach, CEO, Mastercard, said: "Africa is dynamic, fast-growing, and ready to scale its digital future. That won't happen without trust. People don't use what they don't trust. That makes cybersecurity foundational to driving economic resilience and growth across the continent. By doing more to connect public and private sector efforts and share best practices, we can strengthen collective defense and secure a more confident and inclusive digital economy." 

As Africa’s digital economy is projected to reach $1.5 trillion by 2030, the need for greater collaboration has never been more urgent. Cybercrime across Africa is rising sharply, resulting in significant economic losses each year, with only an estimated 35% of incidents officially reported. This underreporting is driven by cyber maturity gaps, limited detection capabilities, and reputational concerns, thus creating a fragmented view of the threat landscape and weakening coordinated response efforts across the region. South Africa is the continent’s most targeted market, accounting for around 29% of ransomware attacks and 40% of phishing incidents in Africa, while Nigeria ranks among the most affected markets for ransomware and dark-web threat activity.

The multi-year initiative will be led by Mastercard. It will begin a phased rollout in 2026, starting with South Africa and Nigeria. Through this collective model, it is intended to support the strengthening of cyber resilience and preparedness and enable more secure digital growth across Africa.

Operating as a pan‑African hub delivered through connected digital platforms and capabilities, the Center will help participating organisations gain greater visibility into emerging threats. This includes a first‑year ecosystem cyber risk analysis covering up to 50 organisations, alongside access to an Africa‑focused threat intelligence feed developed by Recorded Future, a Mastercard company. Through collaboration among CISOs, business leaders and security practitioners - enabled by secure information‑sharing, joint exercises and coordinated response - the Center will strengthen a more connected and resilient cybersecurity ecosystem across Africa.

The Center of Excellence is designed to evolve over time, expanding its capabilities as market needs develop. At the heart of the initiative are three core pillars:

Threat intelligence & strategic insights: Providing participating organizations with Africa-focused threat intelligence, including cybersecurity intelligence assessments across Africa and a shared view of risks.
Collaboration & knowledge sharing: Bringing together CISOs, senior business leaders and security teams to support enhanced collective response capabilities and advance cybersecurity best practices across industries.
Readiness & resilience: Helping organizations anticipate emerging threats through ongoing risk monitoring, resilience assessments, and scenario-based exercises designed to strengthen response and recovery capabilities.
 

The launch of the Africa Cybersecurity Center of Excellence represents the next chapter in Mastercard's broader mission to build trust in the digital economy. The company has invested more than $12.6 billion in cybersecurity innovation since 2018 and has supported the launch of more than 20 cybersecurity-focused startups. This marks a further step in Mastercard’s evolution from a payments network to a trusted technology and cyber intelligence partner, supporting the strengthening of cyber resilience across Africa and enabling secure, inclusive and sustainable digital growth.

By working alongside governments, financial institutions and businesses of all sizes, including SMEs, Mastercard intends to help strengthen the digital foundations that underpin inclusive growth.  By investing in capabilities that address the continent’s evolving realities, Mastercard seeks to support the development of a more secure and resilient digital future across the markets in which it operates.

About Mastercard
Mastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we’re building a resilient economy where everyone can prosper. We support a wide range of digital payments choices, making transactions secure, simple, smart and accessible. Our technology and innovation, partnerships and networks combine to deliver a unique set of products and services that help people, businesses and governments realize their greatest potential. www.mastercard.com


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Contacts
Troy Mocheko

Troy.Mocheko@mastercard.com

Samsung Bioepis Announces Positive Preliminary Phase 1 and Phase 3 Data for SB27, a Proposed Biosimilar to Keytruda (Pembrolizumab)

 INCHEON, Korea - Monday, 29. June 2026 AETOSWire  


Phase 1 study demonstrated pharmacokinetic (PK) equivalence between SB27 and Keytruda; Phase 3 study demonstrated equivalent objective response rate (ORR) at Week 24

Phase 1 and Phase 3 studies expected to be completed within 2026

 


(BUSINESS WIRE) -- Samsung Bioepis Co., Ltd. announced today that the Phase 1 and Phase 3 studies on SB27, a proposed biosimilar to Keytruda1 (pembrolizumab), have met their primary endpoints.


“We are excited to announce preliminary results from the Phase 1 and Phase 3 studies for SB27, our pembrolizumab biosimilar candidate. These topline positive results reinforce our scientific expertise and leadership in biosimilar development,” said Donghoon Shin, Executive Vice President and Head of Clinical Sciences Division at Samsung Bioepis. “We are on track to complete both Phase 1 and Phase 3 studies within this year. Leveraging our robust quality management system, we remain committed to advancing our biosimilar portfolio to broaden access to life-saving biologic medicines for patients with unmet needs.”


Pembrolizumab is a humanized monoclonal antibody that acts as an immune checkpoint inhibitor by targeting and blocking the programmed cell death protein 1 (PD-1) receptor on T cells. It is used to treat various types of cancer, including melanoma, non-small cell lung cancer (NSCLC), and head and neck squamous cell cancer (HNSCC).2


The randomized, double-blind, three-arm, parallel group, multicenter Phase 1 clinical trial demonstrated pharmacokinetic (PK) bioequivalence of SB27 (pembrolizumab) to the reference product Keytruda. The study assessed PK, efficacy, safety, and immunogenicity of SB27, EU-sourced Keytruda, and US-sourced Keytruda in patients with stage II or IIIA NSCLC following complete resection and adjuvant platinum-based chemotherapy.3 163 participants were randomized to receive SB27, EU-sourced Keytruda, or US-sourced Keytruda every 3 weeks up to 51 weeks, and blood samples were collected. The preliminary PK evaluation indicates that the drug exposure, measured by the Area Under the Curve (AUC), has met the predefined equivalence criteria.


The randomized, double-blind, parallel group, multicenter Phase 3 clinical trial demonstrated equivalent objective response rate (ORR) at Week 24. The study assessed efficacy, safety, PK, and immunogenicity of SB27 and Keytruda in patients with metastatic non-squamous NSCLC, followed by chemotherapy.4 555 participants were randomized to receive SB27 or Keytruda followed by pemetrexed and carboplatin5 every 3 weeks up to 48 weeks. The 90% confidence interval (CI) for the ORR ratio between SB27 and Keytruda at Week 24 was 0.737 to 1.071, which completely fell within the pre-defined equivalence margin of 0.712 to 1.405, thereby demonstrating equivalence. Safety, PK and immunogenicity profiles of SB27 were also comparable with those of Keytruda.


About Samsung Bioepis Co., Ltd.


Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology and neurology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.


 


 


1 Keytruda is a trademark of Merck Sharp & Dohme LLC


2 European Medicines Agency (EMA). Keytruda Summary of Product Characteristics (SmPC). Available at: https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf Last accessed June 2026.


3 ClinicalTrials.gov (NCT06268613). A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy. Available at: https://clinicaltrials.gov/study/NCT06268613 (Accessed June 2026)


4 ClinicalTrials.gov (NCT06348199). A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer. Available at: https://clinicaltrials.gov/study/NCT06348199 (Accessed June 2026)


5 Carboplatin was administered for the first four cycles.


 


 


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Contacts

Media Contact

Anna Nayun Kim, nayun86.kim@samsung.com

Yoon Kim, yoon1.kim@samsung.com