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Vialto Partners Completes Recapitalization Transaction

Transaction Completely and Definitively Transforms Vialto’s Capital Structure, Delivering a $225 Million New Money Equity Capital Investment in Vialto and a Reduction of Approximately $550 Million of Existing Debt

NEW YORK, Feb. 25, 2025 /PRNewswire/ — Vialto Partners (“Vialto” or the “Company”), a premier provider of global mobility, tax, and immigration solutions to the world’s leading companies, announced today that it has completed its previously announced recapitalization transaction with a group consisting of its existing financial sponsor, Clayton, Dubilier & Rice (“CD&R”), and certain of its existing debt holders, including funds managed by HPS Investment Partners (“HPS”).

“The completion of this transaction is a vote of confidence by our sponsors and lenders in the kind of company we’re building,” said Neil Masterson, CEO of Vialto. “Vialto helps the world’s leading businesses unlock the potential of their people around the world. We’re home to the industry’s top experts in global workforce mobility, tax, and immigration, and we’ll continue to invest in developing innovative technologies that make us uniquely placed to advise our clients as they navigate a constantly changing world.”

The transaction delivers a $225 million new money equity capital investment in Vialto and an approximately $550 million reduction of existing debt, resulting in a more sustainable capital structure for the group going forward.

Under the transaction, CD&R continues to be the majority shareholder of Vialto and HPS is a minority equity owner.

Weil, Gotshal & Manges LLP, and Latham & Watkins LLP provided legal advice to Vialto. Evercore Group L.L.C. served as financial advisor and AlixPartners LLP acted as operational advisor to Vialto. Debevoise & Plimpton LLP and Kirkland & Ellis LLP provided legal advice to CD&R. Moelis & Company served as financial advisor to CD&R. Paul, Weiss, Rifkind, Wharton & Garrison LLP provided legal advice to HPS. Houlihan Lokey Capital, Inc. served as financial advisor to HPS. Davis Polk & Wardwell LLP and Ashurst LLP provided legal advice to the First Lien Ad Hoc Group and Guggenheim Securities, LLC served as financial advisor. Simpson Thacher & Bartlett LLP provided legal advice to JPMorgan Chase Bank, N.A., the First Lien Facility Agent, and RPA Advisors, LLC served as financial advisor. Holland & Knight LLP provided legal advice to the Second Lien Facility Agent and Bridge Facility Agent.

About Vialto Partners

Vialto Partners works with the world’s leading companies to provide the global mobility, tax, and immigration solutions that enable cross-border operations. As a trusted advisor of compliance, consulting, and technology services to multinational corporations, the firm solves complex, cross-border workforce mobility challenges to ensure its clients and their employees experience a consistent and compliant global mobility experience through Vialto’s cutting-edge technology and deep domain expertise. To learn more, visit www.vialtopartners.com.

Media Contacts:

Vialto Partners
Kal Goldberg / Kerry Golds
Vialtopartners@fgsglobal.com

Captiva Verde Announces Jennifer Bellinger Joins Advisory Board

Vancouver, British Columbia – Newsfile Corp. – February 25, 2025 – Captiva Verde Wellness Corp. (CSE: PWR) (OTC Pink: CPIVF) (“Captiva Verde”) a public company listed on the Canadian Securities Exchange under the trading symbol PWR and further listed in the US OTC Market under the symbol CPIVF announces that Jennifer Bellinger has joined the Advisory Board of Matnaggewinu Development Corporation and Captiva Verde Wellness Corp.

Jennifer, with her strong paternal roots in the Great Sioux Nation, is a committed advocate for indigenous self-sufficiency, economic reconciliation and sustainable long-term growth.

She is an immensely dynamic multifaceted professional, relationship builder and power broker. With a diverse career as a commercial and residential realtor, former pastor, business owner, and rainmaker, she embodies a deep passion for connecting people and fostering successful connections. Jennifer has made a significant impact on every person and in every field she has entered.

Jennifer began her initial journey in education, both as a teacher and a pastor, where she honed her skills in leadership, community building, personal development and communications. Her deep-seated commitment to helping others naturally evolved into a successful career in real estate, guiding families, investors, developers and individuals through some of the most significant financial decisions of their lives. Jennifer has built a reputation for being a trusted advisor and advocate for all of her clients, leveraging her extensive network to ensure the best possible outcomes.

In addition to her work in real estate, Jennifer is also a savvy business owner. She combines an entrepreneurial spirit with a genuine desire to serve others, creating ventures that not only thrive in the marketplace but also empower those around her.

Jennifer’s influence extends beyond her business life; she is also a respected mentor and devoted mother, impressively raising a family of highly respected professional athletes. Her son Cody Bellinger, has reached the pinnacle of Major League Baseball; a 2020 world series champion, 2 x All-Star, MVP, rookie of the year, golden glove, silver slugger and currently playing for the NY Yankees. He precedes his father, Jennifer’s husband Clay Bellinger, with his two-world series wins for the NY Yankees in 1999 and 2000. This is a spectacular achievement of inspiring her family’s dedication to athletics. Another son Cole is spreading his wings as a skilled pilot, also a former pro-baseball player, while her daughter works tirelessly as a professional counselor, impacting lives through her compassionate care. Each of Jennifer’s children embodies her values of hard work, perseverance, and service, making her proud of the contributions they make both on and off the field. Jennifer is a strong advocate of fitness, healthy nutrition and lifestyle, natural remedies and service to the community.

Jennifer’s gift for networking and connecting individuals is unparalleled. She thrives on bringing people together, being it buyers and sellers, aspiring pro athletes and coaches, or professionals seeking collaboration. Through her unwavering support and innate ability to foster meaningful relationships, she continues to enrich the lives of everyone in her orbit.

Jeff Ciachurski, CEO of Captiva Verde states: “Jennifer Bellinger is more than just a successful real estate professional and power broker; she is a community leader, dedicated mother, humanitarian, visionary, and a connector of people who leaves a lasting impact wherever she goes. Through her diverse career and familial achievements, she exemplifies what it means to lead with heart and purpose. We are honored to have her as an Advisor”.

About Matnaggewinu Development Corporation (MDC):

MDC is a Mi’kmaq-led organization committed to advancing economic development for Mi’kmaq communities through sustainable projects and partnerships. The corporation focuses on initiatives that preserve Mi’kmaq culture while fostering economic self-reliance and prosperity. Matnaggewinu Development Corporation (MDC) is 49% owned by Captiva Verde.

About Captiva Verde:

Captiva is dedicated to building partnerships that support Indigenous development and economic growth in key sectors such as real estate-based hospitality, tourism, aviation and renewable resources.

On Behalf of the Board of Directors

“Jeff Ciachurski”

Jeffrey Ciachurski
Chief Executive Officer and Director
Cell: (949) 903-5906
E-mail: westernwind@shaw.ca

Neither Canadian Securities Exchange nor its regulation services provider accepts responsibility for the adequacy or accuracy of this release.

Cautionary Note Regarding Forward Looking Information

This news release includes “forward-looking statements” and “forward-looking information” within the meaning of Canadian securities laws and United States securities laws (together, “forward-looking statements”). All statements included in this news release, other than statements of historical fact, are forward-looking statements including, without limitation, statements with respect to the expansion of Captiva’s health and wellness platform.

Forward-looking statements include predictions, projections and forecasts and are often, but not always, identified by the use of words such as “anticipate”, “believe”, “plan”, “estimate”, “expect”, “potential”, “target”, “budget”, “propose” and “intend” and statements that an event or result “may”, “will”, “should”, “could” or “might” occur or be achieved and other similar expressions and includes the negatives thereof.

Forward-looking statements are based on a number of assumptions and estimates that, while considered reasonable by management based on the business and markets in which the Company operates, are inherently subject to significant operational, economic, and competitive uncertainties, risks and contingencies. These include assumptions regarding, among other things: general business and economic conditions. There can be no assurance that forward-looking statements will prove to be accurate and actual results, and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include those described under the heading “Risks and Uncertainties” in the Company’s most recently filed MD&A (a copy of which is available under the Company’s SEDAR profile at www.sedar.com). The Company does not undertake to update or revise any forward-looking statements, except in accordance with applicable law.

The issuer is solely responsible for the content of this announcement.

Valvoline™ Global Operations Celebrates Contributions of Mechanics Worldwide in Annual Appreciation Initiative

Global leader in automotive and industrial solutions announces sixth annual Mechanics Month, dedicating March to celebrating the hard work and hands-on expertise of mechanics around the world.

LEXINGTON, Ky., Feb. 25, 2025 /PRNewswire/ — Valvoline™ Global Operations, maker of The Original Motor Oil, today announced its 6th annual Mechanics Month initiative. Beginning Monday, March 3, the annual campaign celebrates the often-unsung heroes of the mobility industry and beyond – the mechanics who keep the world moving forward.

Valvoline Global Operations, global leader in automotive and industrial solutions, announces sixth annual Mechanics Month, dedicating March to celebrating the hard work and hands-on expertise of mechanics around the world.
Valvoline Global Operations, global leader in automotive and industrial solutions, announces sixth annual Mechanics Month, dedicating March to celebrating the hard work and hands-on expertise of mechanics around the world.

This year’s theme, “The Future is in Your Hands”, shines a spotlight on mechanics across the globe, highlighting their expertise, skill, and heart for the critical work they do each day. From independent workshops to dealerships, construction sites to fleets, mechanics solve problems that others can’t. Yet, fixing machinery is only part of the job; mechanics serve as educators and partners to their customers, offering peace of mind when it matters most.

“Valvoline Global is proud to honor the important contributions of mechanics worldwide,” said Jamal Muashsher, Valvoline Global Chief Executive Officer. “Mechanics Month is about recognizing the mechanics in our local communities who not only maintain the present – but also shape the future – by keeping people around the world moving forward.”

Global Recognition of Local Mechanics

As part of Mechanics Month, Valvoline Global teams in over 60 countries will celebrate local mechanics, working with community members to acknowledge their service. Notable celebrations spanning multiple regions include:

  • Providing over 100 toolboxes, including safety gear and Valvoline-branded merchandise, to mechanics at workshops throughout Thailand.
  • Hosting thank you dinners featuring games, prizes and live entertainment for mechanics and their families throughout Southeast Asia.
  • Teaming up with Hendrick Motorsports for surprise deliveries of Valvoline Mechanics Month packages to hardworking team mechanics in the U.S.
  • Working with select distributor and school partners to offer dozens of scholarships across Mexico and El Salvador.
  • Offering brand and product training to over 200 mechanics and various scholarship programs and initiatives throughout China.

The company will also feature mechanics in global web and social media spotlights during the month of March.

Grand Prix Meets Gratitude

As the Official Lubricant Partner of the Aston Martin Aramco Formula One® (AMAF1) Team, Valvoline Global will further collaborate with its AMAF1 partner to highlight the importance of continuously building a pipeline of talented mechanics.

For the second year in a row, AMAF1 will participate in Valvoline Global’s Aspiring Mechanics Program as they invite students from Milton Keynes College (United Kingdom) to learn from F1 mechanics.

The Valvoline Global Aspiring Mechanics Program, established in 2024, is focused on educating and supporting future mechanics as they grow their skills. Through this program, the company aims to play a direct role in minimizing the growing shortage of mechanics globally, while raising awareness of the importance of the trade.

Join the Celebration

As a long-time supporter of mechanics throughout its 150+ year history, Valvoline Global is proud to continue its annual celebration of mechanics and invites the public to join them in recognizing these hard-working individuals. Learn more by visiting https://www.valvolineglobal.com/en/mechanics-month/ and by following Valvoline Global’s social channels to view stories of industry heroes featured throughout the month.

About Valvoline™ Global Operations

THE ORIGINAL. Inventing the Way Forward.

Valvoline™ Global Operations is a worldwide leader in automotive and industrial solutions, creating future-ready products and best-in-class services for partners around the globe. Established in 1866, we introduced the world’s first branded motor oil, claiming our position as The Original Motor Oil.

As The Original, we’ve been innovating to solve problems for over 150 years. With sales in more than 140 countries and territories, our solutions are available for every engine and drivetrain, including high-mileage and heavy-duty vehicles, offered at more than 80,000 locations. And we’re committed to powering the future of mobility for vehicles with electric, hybrid and internal combustion powertrains – today and as we move forward. We are now a part of Aramco, one of the world’s largest integrated energy and chemicals companies. Our strategic partnership creates a powerful combination to drive unparalleled product innovation and sustainable business solutions.

To learn more visit www.valvolineglobal.com.

 

 

New Research Shows Surging Consumer Demand for AI-Banking Services, According to Personetics Global Survey

A survey of 2,000 bank customers reveals that 84% are likely to switch banks to access services that help them reach their financial goals

NEW YORK, Feb. 25, 2025 /PRNewswire/ — Personetics, the company that transforms how banks build and monetize customer relationships, today announced the release of its global survey report: Understanding Consumer Demand in the AI-Banking Era.  The report reveals that individuals rank financial wellness as their top life concern, surpassing health and family relationships. A majority of survey participants (84%) indicated that they would likely switch to a bank that provides timely, relevant advice to improve their financial health. Such comprehensive personal banking insights and timely product recommendations necessitate AI-driven features to achieve this level of service.

Personetics Global Banking Survey
Personetics Global Banking Survey

Personetics surveyed 2,000 banking customers across North America, EMEA, and APAC, finding that 74% would likely display greater loyalty to a bank that helps them achieve their financial goals through timely insights and autonomous spending and saving actions.

Key findings from the global report include:

  • Seventy percent of customers strongly want their bank to proactively analyze and understand their financial situation and needs according to their daily spending and saving habits. About three-quarters express a preference for AI-driven financial insights, such as alerts for double billing, overdraft warnings, and savings nudges.
  • Seventy-four percent of customers would be more loyal to their bank if it offered personalized tips and insights tailored to their daily spending and saving habits. This is significant because, with most banking services now being digital, switching providers has become easier, and the rise of open banking will further simplify the process.
  • Although there was a strong demand for these services worldwide, customers in the EMEA region exhibited the highest interest, with 79% compared to the global average of 70%. This is not surprising, given that banks and government regulators in EMEA have endorsed financial wellness services.
  • Gen Z customers (ages 17-27) show significantly higher interest in these services compared to other age groups. Eighty-six percent of Gen Z respondents report their interest, compared to a 70% average across all age groups. Interestingly, the second-highest level of interest comes from those over 60, with 76% expressing enthusiasm.

“Today’s consumers are digitally savvy and expect advanced, personalized banking experiences,” said Udi Ziv, CEO of Personetics. “Banks must meet this demand by providing comprehensive, needs-based services that leverage AI-driven insights and advice to assist their customers in making smarter financial decisions. Banks are discovering that these services enhance customer loyalty and, consequently, drive product sales, demonstrating that financial wellness benefits everyone involved. These services are not merely optional for banks; they are essential.”

This global survey underscores the urgent need to address the soaring customer demand for AI-driven banking services. By leveraging its AI-driven platform, Personetics is transforming everyday banking into a highly personalized, data-driven experience that enables banks to deepen customer relationships, drive meaningful financial actions, and ultimately enhance financial well-being.

To access the full results, download the “Understanding Consumer Demand in the AI-Banking Era” survey report here.

About Personetics

Personetics is the global leader in transforming how banks build and monetize customer relationships by enabling them to dynamically respond to consumers’ evolving financial needs with contextual and highly relevant insights, making them smarter about their money and eager to act. The AI-powered platform allows financial institutions to boost customer engagement and satisfaction, resulting in increased digital adoption and sales conversions. Personetics supports 150 million customers across 35 global markets and serves leading financial institutions. The company has offices in New York, London, Singapore, São Paulo, and Tel Aviv. For more information, visit https://personetics.com/.

Media contact:
Ellery Smith
personetics@fullyvested.com 

 

Ascenda and Galileo Financial Technologies Collaborate to Elevate Card Loyalty Programs

Partnership combines Galileo’s technology platform and Ascenda’s loyalty expertise to simplify and power card loyalty programs

NEW YORK, Feb. 25, 2025 /PRNewswire/ — Ascenda, the industry leader in loyalty-as-a-service, has partnered with Galileo Financial Technologies, SoFi Technologies, Inc.’s Tech Platform (NASDAQ: SOFI), to deliver seamless and engaging loyalty experiences through card loyalty programs to banks, fintechs and other brands.

This collaboration integrates Ascenda’s loyalty and customer engagement solutions with Galileo’s robust financial technology platform, offering clients an end-to-end path to launch loyalty card programs. Galileo’s advanced financial services infrastructure, combined with Ascenda’s expertise in rewards fulfillment, creates an unparalleled solution for enhancing customer acquisition, engagement, and retention.

“By aligning our expertise in crafting growth-oriented loyalty propositions with Galileo’s technology platform, we’re delivering a compelling solution for brands,” said Josh Berwitz, Chief Commercial Officer of Ascenda. “With this collaboration, our clients can launch compelling programs that seamlessly integrate with top-tier loyalty programs in travel, hospitality, and beyond.”

Together, Ascenda and Galileo are tackling key loyalty challenges for financial institutions, fintechs and other brands by delivering a comprehensive, end-to-end solution. Galileo simplifies card issuing, while Ascenda ensures seamless loyalty integration, creating frictionless reward experiences that boost customer satisfaction and ROI.

“Our collaboration with Ascenda represents an exciting offering for our clients,” said David Feuer, Chief Product Officer, Galileo. “Together, we’re empowering organizations to launch loyalty-driven card programs that engage customers on a deeper level, enable faster time-to-market, and drive meaningful results.”

This partnership continues to accelerate Ascenda’s global loyalty ecosystem, enhancing its ability to drive growth for financial brands worldwide.

About Ascenda: Ascenda delivers loyalty-as-a-service for financial institutions and merchants globally, unlocking superior ROI across customer acquisition, engagement, and retention. With over a decade of proven results, an unrivaled roster of top-tier global clients, and enterprise- grade technology, Ascenda is trusted by leading brands to deliver growth outcomes, eliminate complexity, and create extraordinary customer experiences. For more information, please visit ascenda.com

About Galileo: Galileo Financial Technologies, LLC and certain of its affiliates collectively comprise a financial technology company owned and operated independently by SoFi Technologies, Inc. (NASDAQ: SOFI) that enables fintechs, financial institutions, and emerging and established brands to build differentiated financial solutions that deliver exceptional, customer-centric experiences. Through modern, open APIs, Galileo’s flexible, secure, scalable and fully integrated platform drives innovation across payments and financial services. Trusted by digital banking heavyweights, early-stage innovators and enterprise clients alike, Galileo supports issuing physical and virtual payment cards, mobile push provisioning, tailored and differentiated financial products and more, across industries and geographies. For more information please visit galileo-ft.com

©2025 Galileo Financial Technologies, LLC. All rights reserved.

Galileo Financial Technologies, LLC is a technology company, not a bank. Galileo partners with many issuing banks to provide banking services in North and Latin America.

Kangpu Biopharmaceuticals Received IND Approval from NMPA for KPG-818 to Treat Relapsed/Refractory Multiple Myeloma

HEFEI, China, Feb. 25, 2025 /PRNewswire/ — Kangpu Biopharmaceuticals, Ltd. (“Kangpu”) today announced that the Company has received IND approval from the CDE (Center for Drug Evaluation) of China National Medical Products Administration (NMPA) for KPG-818 for the treatment of relapsed/refractory multiple myeloma (RRMM).

IND approval record on CDE official website
IND approval record on CDE official website

KPG-818 is a novel oral molecular glue modulator of the E3 ubiquitin ligase complex CRL4-CRBN. It demonstrated high cereblon (CRBN) binding affinity and potent degradation of Aiolos (IKZF3) and Ikaros (IKZF1), two members of the Ikaros family of zinc-finger transcription factors associated with B-cell development. KPG-818 possesses immunomodulatory, anti-angiogenic, and anti-tumor effects.

The Phase I clinical trial of KPG-818 in the United States for the treatment of various hematological tumors has been completed. Preliminary results indicate that in RRMM patients who have previously received two immunomodulatory drugs (lenalidomide and pomalidomide), at least one proteasome inhibitor (bortezomib, ixazomib, or carfilzomib), and a CD38 monoclonal antibody (daratumumab or isatuximab), KPG-818 demonstrated good safety, tolerability, pharmacokinetic characteristics, and encouraging therapeutic effects.

About Kangpu Biopharmaceuticals

Kangpu Biopharmaceuticals, Ltd. is a clinical-stage company focused on the discovery and development of innovative therapeutics for the treatment of solid tumors, hematologic malignancies, autoimmune diseases, and inflammatory disorders through novel solutions, including targeted protein degradation. Kangpu has developed a robust pipeline of potential first-in-class and best-in-class drug candidates based on proprietary technology platforms, including NeoMIDES®, gDACs®, and X-SYNERGY®.

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

 

CARsgen Therapeutics Introduced Zhuhai SB Xinchuang to Accelerate Allogeneic CAR-T Cell Products Development in Mainland China

SHANGHAI, Feb. 25, 2025 /PRNewswire/ — CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK, “CARsgen Therapeutics“), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces reaching agreements with an investment fund managed by Zhuhai Hengqin SB Xinchuang Equity Investment Management Enterprise (Limited Partnership)  (“Zhuhai SB Xinchuang“) to jointly invest in UCARsgen Biotech Limited (“UCARsgen“), a China-based new drug discovery biotechnology company focused on allogeneic CAR-T cell therapies for the treatment of hematologic malignancies.

Under the agreements, UCARsgen has secured the exclusive rights in mainland China for the research, development, manufacture, and commercialization of the following allogeneic CAR-T products from CARsgen Therapeutics: the BCMA-targeted allogeneic CAR-T cell therapy for the treatment of multiple myeloma and plasma cell leukemia and the CD19/CD20 dual-targeted allogeneic CAR-T cell therapy for the treatment of B-cell malignancies. An investment fund managed by Zhuhai SB Xinchuang (currently undergoing registration and filing procedures) subscribed to the newly increased registered capital of UCARsgen for a consideration of RMB 80,000,000, thus retaining an 8% equity stake in the registered capital of UCARsgen upon completion of the transaction, equity stake of CARsgen Therapeutics in UCARsgen will be diluted from 100% to 92%.

About CARsgen Therapeutics Holdings Limited

CARsgen is a biopharmaceutical company with operations in China and the U.S., focusing on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. CARsgen has established a comprehensive CAR T-cell research and development platform that covers target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. Internally, CARsgen has developed novel technologies and a product pipeline with global rights to address significant challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. CARsgen’s mission is to become a global biopharmaceutical leader that provides innovative and differentiated cell therapies for cancer patients worldwide and makes cancer curable.

Forward-looking Statements

All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group’s current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group’s control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading “Principal Risks and Uncertainties” in our most recent annual report and interim report and other announcements and reports made available on our corporate website, https://www.carsgen.com. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release.

SK bioscience Initiates Global Clinical Trials of mRNA Japanese Encephalitis Vaccine Candidate

  • SK bioscience’s first mRNA vaccine candidate enters Phase 1/2 clinical trials in Australia and New Zealand, with interim results expected by 2026
  • Joint R&D project between SK and CEPI includes up to USD 40 million in initial funding support from CEPI
  • SK bioscience will expand its vaccine portfolio and secure global competitiveness by developing mRNA vaccines

SEONGNAM, South Korea, Feb. 25, 2025 /PRNewswire/ — SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, today announced the commencement of global Phase 1/2 clinical trials for its mRNA-based Japanese encephalitis vaccine candidate, GBP560.

SK bioscience L HOUSE manufacturing plant
SK bioscience L HOUSE manufacturing plant

SK bioscience’s development of vaccine for Japanese encephalitis could not only help to protect against Japanese Encephalitis but also pave the way to the development of an mRNA technology that could be potentially adapted in a matter of weeks to develop a vaccine against a novel as-yet-identified infectious disease ‘Disease X’.

This rapid response approach would support the ‘100 Day Mission’, a global initiative spearheaded by the Coalition for Epidemic Preparedness Innovations (CEPI) and embraced by the G7, G20 and pharmaceutical companies to accelerate the development of new vaccines against pandemic threats to just over three months following the identification of a Disease X.

This project is based on an R&D agreement with CEPI, which committed USD 40 million initial funding, in 2022 to support preclinical and early clinical trials of Japanese encephalitis as well as Lassa fever virus vaccines. A further USD 100 million in funding could be made available later to support late-stage trials/licensure to further validate the mRNA platform and have it ready for use in outbreak situations.

SK bioscience’s leadership in next pandemic preparedness was recognized as a key R&D partner of CEPI in the ‘100 Day Mission Implementation Report 2024’ recently published by the influential International Pandemic Preparedness Secretariat (IPPS), a global body set up to monitor global readiness for widespread disease outbreaks.

Through this project, SK bioscience aims to establish a mRNA vaccine technology capable of addressing not only pandemic threats but also various infectious diseases. By expanding its vaccine pipeline, the company seeks to enhance its competitiveness in the global vaccine industry.

The mRNA vaccine technology, which was first commercialized in the COVID-19 vaccines during the pandemic, is available for rapid mass production compared to traditional technologies by utilizing genetic sequences. This capability makes mRNA technology well-suited for pandemic response. Furthermore, the mRNA vaccine technology shows significant potential to be applied to the development of therapeutic drugs, signaling rapid market expansion.

According to global market research firm ‘Nova One Advisor’, the global mRNA therapeutics market is projected to surpass around USD 58.90 billion in 2033, registering a CAGR of 17.06% by 2033.

During the Phase 1/2 trials, the company will evaluate the immunogenicity and safety of GBP560, the company’s first mRNA-based vaccine candidate, in 402 healthy adult participants in Australia and New Zealand. In stage 1, the participants will receive two shots of low, medium, high-dose vaccine, or a control vaccine administered 28 days apart. Based on the stage 1 results, the optimal dosage and regimen will be determined for further assessment of the immunogenicity and safety compared to the control group in stage 2. The company aims to secure interim results by 2026.

Previously, in preclinical studies, the vaccine candidate demonstrated superior safety and immunogenicity through repeated-dose toxicity studies, safety pharmacology tests, and preclinical protective immunity studies.

CEPI and SK bioscience are committed to enabling global equitable access to the vaccines they develop. Under the terms of the funding agreement, SK bioscience has committed to achieving equitable access to the outputs of this project including prioritization of supply for low-income and middle-income countries, production of vaccine volumes required to meet public health needs, and affordable pricing, in line with CEPI’s Equitable Access Policy.

Dr Richard Hatchett, CEO of CEPI, said: “We don’t know when the next Disease X will strike or where – but we know that it is coming. Preparing technologies ahead of time by building on the successes of mRNA allows us to not lose time creating a new vaccine from scratch when a viral threat emerges. This puts us on track to defeating a future outbreak quickly and equitably.”

Jaeyong Ahn, CEO of SK bioscience, said, “Expanding our capabilities with the mRNA platform will enable rapid responses to unknown diseases while ensuring equitable access to vaccines and sufficient vaccine supply worldwide. We are committed to successfully advancing this clinical trial, contributing to public health and strengthening our position as a global leader in vaccine R&D.”

About SK bioscience

SK bioscience is an innovative vaccine and biotech company, committed to vaccine development and manufacturing to enable more equitable access to vaccines around the world. Leveraging strengths on cutting-edge technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. With the cooperation of domestic and international governments, regulatory agencies, healthcare providers, doctors, and medical experts, all of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions.
SK bioscience Website
SK bioscience Linkedin

Contact
Communications Team
Changhyun Jin (jin99@sk.com), Jeannie S. Pak (j.pak@sk.com)