–        Topline supports moving to Phase 3 trial and shows potential to develop GV1001 as the world’s first PSP treatment

SEOUL, South Korea, Oct. 29, 2024 /PRNewswire/ — GemVax & KAEL Co., Ltd. (“GemVax”; KOSDAQ ticker: 082270) announced that topline results of a Phase 2a clinical trial (the “Phase 2a PSP Clinical Trial”) of GV1001, an investigational peptide drug for the treatment of progressive supranuclear palsy (“PSP”), were presented at “Neuro2024: The PSP and CBD International Research Symposium” in Toronto, Canada, at 4:45 p.m. local time on 24^th October.

PSP is a degenerative disease that, like Parkinson’s disease, causes symptoms such as gait disturbances, early falls, vertical gaze palsy, rigidity, tremors, and cognitive decline, but it progresses faster and currently has no fundamental treatment. PSP is classified into several types, including PSP-Richardson’s syndrome (“PSP-RS”) and PSP-parkinsonism (“PSP-P”). Compared to other types of PSP, the PSP-RS type shows a greater accumulation of tau protein and affects larger areas, including the cerebellum, dentate nucleus, pontine nuclei, frontal lobe, and parietal lobe.

The Phase 2a PSP Clinical Trial was a 24-week, randomized, double-blind, placebo-controlled, prospective exploratory clinical trial conducted in 78 patients with PSP at 5 centers in Korea. The participants were randomized 1:1:1 to receive either placebo or GV1001 0.56 mg or GV1001 1.12 mg administered subcutaneously once weekly for the first 4 weeks (1 month), and then at 2-week intervals for 20 weeks (5 months) for a total of 24 weeks (6 months). Patients with both PSP-RS and PSP-P types were eligible to participate in the study. Results showed higher benefits in the lower dose group (0.56 mg), particularly in PSP-RS type patients.

The primary endpoint of the trial was change from baseline in total score (calculated as the least-square mean using MMRM method) of PSP-Rating Scale after 24 weeks of GV1001 administration, which showed deterioration by 2.14 points in GV1001 0.56 mg dose group compared to 4.10 points in the placebo group, demonstrating a 48% reduction in disease progression (see Figure 1). Although statistical significance was not demonstrated, the results support the potential of GV1001 as a treatment of PSP, a disease for which there is currently no cure, and the potential to advance GV1001 into further clinical trials.

The clinically typical PSP is often referred to as the PSP-RS type, which accounts for the majority of PSP patients. This type progresses faster and has a shorter average survival time compared to other PSP types. Subgroup analysis was conducted in patients with PSP-RS type only. The change from baseline in PSP-Rating Scale total score mean (calculated using simple average) at 24 weeks of GV1001 administration to PSP-RS type patients was a deterioration by 0.25 points in the GV1001 0.56 mg dose group compared to a deterioration by 5.19 points in the placebo group, demonstrating a 4.94-point difference or a 95% reduction in disease progression (see Figure 2).

Many PSP-RS type patients in the treatment group experienced symptom stabilization or even improvement during the clinical period. When calculated as responder rate based on the percentage of patients whose PSP Rating Scale scores improved or remained stable after six months of treatment compared to baseline, 58.33% of PSP-RS type patients in the 0.56 mg GV1001 group showed improvement or stabilization (see Figure3).

The safety profile of GV1001 in the Phase 2a PSP Clinical Trial was consistent with prior safety data. GV1001 was generally well-tolerated with no serious adverse events related to the drug reported.

Hyungsik Moon, CSO of GemVax, stated that “this Phase 2a trial was an exploratory study to determine the optimal dosage and find out how the peptide works on different subgroups. Although the topline result did not achieve statistical significance, the evidence is strong enough to consider moving forward to a pivotal trial and shows potential to develop GV1001 as the world’s first treatment option for PSP.”

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Experts at the Neuro2024 meeting welcomed the results of the PSP trial as encouraging and expressed excitement for the drug to enter a global Phase 3 clinical trial for further development.

“This pilot study was not fully powered and the treatment duration with 6 months was short. Thus, statistically significant confirmatory results could not be expected” said Peter Schüler, MD, Senior Vice President of Drug Development at global CRO ICON. “Nonetheless, the observed trends are very plausible and consistent in two domains: motor performance and cognitive function, both favoring the lower dose group.”

“The trial identified the optimal dose, which was one of the primary objectives of the Phase 2a study, and demonstrated clinically meaningful benefits, namely full stabilization of the disease compared to the placebo group,” said Dr. Schüler, adding “these topline results provide a strong foundation for advancing to Phase 3.”

Dr. Günter U. Höglinger, Head of the Department of Neurology, LMU Hospital, Munich, and a world-renowned expert in PSP, commented: “very exciting Phase 2 level data with novel drug study with new mechanisms of action. Data is preliminary but very promising and it is in line with [GV1001] Alzheimer’s  disease clinical data. I look forward to further development and very excited to participate and lead the [PSP] Phase 3 study.”

Dr. Kristophe Diaz, Director of CurePSP, said that “we are encouraged by the results of the recent GemVax clinical trial, which offer hope to the entire PSP community, including patients who currently have no treatment options, their families and the physicians who care for them” and that “we congratulate GemVax on the successful completion of this trial and look forward to further developments that benefit the PSP community.” He also said that “CurePSP remains committed to collaborating and supporting efforts that bring hope and progress for those affected by this devastating disease.”

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About Phase 2a PSP Clinical Trial (NCT05819658)

The Phase 2a PSP clinical trial was a 24-week, multicenter, randomized, double-blind, placebo-controlled, prospective phase 2a exploratory clinical trial to evaluate the safety and efficacy of GV1001 0.56 mg or 1.12 mg compared to placebo for the treatment of patients with PSP. The primary outcome of the study was change from baseline in the total score of PSP-Rating Scale after 24 weeks of GV1001 administration. Secondary endpoints included change from baseline in the total score of PSP-Rating Scale at 3 months, MoCA-K, K-FAB and ES-ADL at both 3 and 6 months. Overall safety of GV1001 administration was also assessed.

About GV1001

GV1001 is a synthetic peptide consisting of 16 amino acids based on the key sequence of telomerase. GV1001 has been studied for the potential treatment of neurodegenerative diseases including Alzheimer’s disease and PSP. In neurodegenerative diseases, GV1001 has been demonstrated to modulate phenotypes of glial cells, and to regulate neuroinflammation. In addition to the Phase 2a PSP clinical trial, a Phase 2 Alzheimer’s disease clinical trial of GV1001 is currently ongoing in the U.S. and Europe (NCT05189210).

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About PSP

Progressive supranuclear palsy is a rare progressive and adult-onset neurodegenerative disease that currently has no disease-modifying drug. Approximately seven in 100,000 people worldwide is affected by PSP and is more common in men. People over the age of 60 are mainly affected. The symptoms of PSP include loss of balance, changes in personality, weakness of eye movements, especially in the downward direction, difficulty in swallowing, slurred speech and cognitive impairment. 

About GemVax & KAEL

GemVax & KAEL Co., Ltd. is a pioneering clinical-stage biopharmaceutical company based in Korea, dedicated to developing proprietary therapeutics for neurodegenerative diseases including progressive supranuclear palsy and Alzheimer’s disease. As for PSP, GemVax is currently conducting a Phase 2a study in Korea to evaluate the efficacy and safety of GV1001 in patients with PSP. Preparations are also underway for a global PSP clinical trial. In addition, GemVax is currently conducting a Phase 2 Alzheimer’s disease clinical trial in the U.S. and Europe. For more information, visit www.gemvax.com and follow us on Linkedin. 

Forward-Looking Statements

This document contains information that includes or is based upon “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements may or may not include identifying words such as “plan,” “will,” “expect,” “anticipate,” “intend,” “believe,” “potential,” “continue,” and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties. All forward-looking statements are based on management’s current estimates, projections, and assumptions, and GemVax undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law.

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STOCKHOLM, Oct. 29, 2024 /PRNewswire/ — Tap to Pay on iPhone is now available for SumUp customers in Sweden, Ireland, Austria, Czech Republic and Romania. Using Tap to Pay on iPhone, SumUp merchants can now seamlessly accept contactless payments, including credit and debit cards, Apple Pay and other digital wallets, using only an iPhone and the free SumUp iOS app, with no additional hardware needed.

The availability for SumUp customers means that merchants – even the smallest, or most recently launched ventures – can accept contactless payments anywhere, as long as they have a compatible iPhone and the SumUp iOS app. Tap to Pay on iPhone can be an ideal stepping stone for nano merchants as they look to scale their business and consider payment solutions, alongside other business tools. Tap to Pay on iPhone can also complement and extend existing point of sale systems – for example, by service staff at eateries. The service is therefore an important step in democratising digital payments, something which SumUp has pioneered and led for over a decade.

Marc-Alexander Christ, co-founder of SumUp, said: “SumUp is pleased to announce the availability of Tap to Pay on iPhone for merchants in more markets across Europe . Our mission is to make business simple for our merchants and this roll-out is an extension of our existing work supporting SMEs and merchants of all sizes to get paid. Importantly, Tap to Pay on iPhone is easy, secure and private. I am especially pleased with the exceptional functionality of the product and the fact it lowers barriers to entry, with the potential to fuel entrepreneurship.”

Tap to Pay on iPhone uses the built-in features of iPhone to keep business and customer data private and secure. When a payment is processed, Apple does not store card numbers or transaction information on the device or on Apple servers.

Tap to Pay on iPhone accepts all forms of contactless payments, including contactless credit and debit cards, Apple Pay, and other digital wallets. SumUp merchants will have the ability to activate Tap to Pay on iPhone directly within the app settings.

The service is available for those with an iPhone XS or later, running the latest version of iOS.

SumUp has always championed businesses of all sizes. With a portfolio of products, from card readers to invoicing, the online store builder to a business account (and so much more), SumUp makes it easier for merchants to get paid doing what they love. As the needs and demands of business have evolved since the company’s founding in 2012, SumUp has diversified its product suite and expanded its solutions ecosystem.

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About SumUp

SumUp is a leading global financial technology company driven by the purpose of levelling the playing field for small businesses. Founded in 2012, SumUp is the financial partner for more than 4 million small merchants in 36 markets worldwide, helping them start, run and grow their business. Through its SuperApp, SumUp can provide merchants with a free business account and card, an online store, and an invoicing solution – as well as in-person and remote payment acceptance seamlessly integrated with SumUp’s card terminals and point-of-sale registers. SumUp is committed to leveraging its success to make the world a better place, pledging to donate 1% of its revenue to support environmental causes and advocating for educational and entrepreneurial projects around the world. In 2023 SumUp was recognised as a Top Global Employer for inclusion by the Stonewall Workplace Equality Index.

For more information, please visit www.sumup.com/sv-se  

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Contact Details: 
Gabriel Destremaut, [email protected]  

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ANTWERP and AALST, Belgium, Oct. 29, 2024 /PRNewswire/ — Bluecrux, a leading value chain consulting and technology firm, is thrilled to announce its successful collaboration with Bridgestone on the implementation of SAP S/4HANA. This state-of-the-art enterprise resource planning (ERP) system is set to streamline operations and boost business efficiency across Bridgestone’s global operations, replacing its older version of SAP ahead of 2027, when it will no longer be supported.

The SAP S/4HANA system officially went live at Bridgestone at the beginning of this year, making an impact on over 3,800 end users across 9 manufacturing sites and 8 sales regions. Bluecrux worked closely with Bridgestone’s internal teams to ensure a smooth transition as it upgraded its ERP system. Bluecrux provided hands-on support during this critical time, providing hypercare with teams on-site at 20 locations to monitor SAP S/4HANA’s integration on an end-to-end level. The company also set up daily reports to track key highlights and quickly solve any issues at every site.

Since the implementation of SAP S/4HANA, Bridgestone has been able to harmonize its processes across the organization. The platform is seen as a crucial enabler for future initiatives and projects as it improves supply chain visibility, accelerates financial reporting and enhances the company’s ability to respond to market demands more efficiently.

“The collaboration with Bluecrux has been a key part of our digital transformation journey,” said Donald Connally, RYOGA Program Manager of Bridgestone. “Their expertise in supply chain processes and hands-on approach, ensured a seamless transition to SAP S/4HANA across our global operations. We’re grateful for the Bluecrux team’s dedication and proactive support through hypercare, helping us reach our goals.”

This project is the latest achievement in the long and successful partnership between Bluecrux and Bridgestone. Over the years, Bluecrux has been by Bridgestone’s side as it goes through the phases of its supply chain transformation. Together, their respective teams have tackled projects like production planning, demand and allocation planning and developing a global Advanced Planning System (APS) strategy. This strong foundation paved the way for the recent SAP S/4HANA roll-out, bringing together years of shared expertise and trust.

“Our ongoing partnership with Bridgestone has been built on mutual trust and a shared commitment to continuous improvement,” said Anneleen Tronquo, Managing Parter of Planning Solutions at Bluecrux. “The successful SAP S/4HANA implementation marks a significant milestone in our journey together, and it showcases the power of collaboration and hands-on support. We’re proud to be part of this journey and look forward to driving even greater achievements together.”

The success of this SAP S/4HANA project underscores Bluecrux’s deep expertise in deploying and monitoring the solution, as well as the company’s commitment to supporting clients in meeting their business transformation aims. As Bridgestone continues to benefit from SAP S/4HANA, Bluecrux looks forward to providing ongoing support for the company’s digital journey.

Navigating your own SAP S/4HANA transformation? Reach out to us and discover how Bluecrux can support your transformation journey.

About Bluecrux

Founded in 2011, Bluecrux is a leading value chain technology and consulting company, assisting global companies to navigate and improve their supply chains. The company’s international growth story and innovative technologies, Binocs and Axon, reflect its goal to combine expertise with technology, turning challenges into opportunities.

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About Bridgestone 

Bridgestone in Europe, the Middle East and Africa (Bridgestone EMEA) is the regional Strategic Business Unit of Bridgestone Corporation, a global leader in premium tires and sustainable mobility solutions. Headquartered in Zaventem (Belgium), Bridgestone EMEA employs more than 14,000 people and conducts business in 35 countries across the region. Bridgestone EMEA operates 13 tire plants, a major R&D center, and a proving ground, and serves its customers in an extensive retail network with thousands of touchpoints.  Bridgestone offers a diverse portfolio of premium tyres, tyre technologies and advanced mobility solutions. The company’s vision is to provide social and customer value as a sustainable solutions company. The Bridgestone E8 Commitment is a broad, global corporate commitment that clearly defines the value the company is promising to deliver to society, our customers and future generations in eight focus areas; Energy, Ecology, Efficiency, Extension, Economy, Emotion, Ease and Empowerment. These provide a compass to guide strategic priorities, decision making and actions throughout every area of the business.

Olivier Souffriau,
Business Alliance Manager Bluecrux,
[email protected], 
+32476382612

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