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GemVax Announces Topline Results from Phase 2a Progressive Supranuclear Palsy Clinical Trial at Neuro2024

Published

4 weeks ago

October 29, 2024

– 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.”

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).

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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China’s AIMA brand electric motorbike is now in Bangladesh

Published

2 hours ago

November 23, 2024

CISION (PR Newswire)

DHAKA, Bangladesh, Nov. 23, 2024 /PRNewswire/ — With the popularity of electric vehicles in Bangladesh, the globally renowned AIMA brand has also arrived in Bangladesh. The esteemed DX Group has brought the AIMA F-626 to customers. This environmentally friendly battery-operated electric motorbike has already been approved by the Bangladesh Road Transport Authority (BRTA) now.

In light of the increasing popularity of electric motorcycles in the country, the internationally-leading brand AIMA has entered the market. By the end of 2023, AIMA electric two-wheelers had established a presence in over 50 countries worldwide, with 11 global production bases, including overseas factories in Indonesia and Vietnam. In 2022, AIMA collaborated with Rob Janoff, the designer of the Apple logo, to refresh the brand’s VI system with a youthful and fashionable image. In 2023, AIMA teamed up with PANTONE, the global authority in color expertise, to create the trending color of the year. As an industry leader, AIMA spearheads the electric two-wheeler sector and showcases the prowess of a leading electric two-wheeler brand on a global scale. As of March 31, 2024, AIMA’s total electric two-wheeler sales had reached 80 million units, earning certification from Frost & Sullivan, a globally recognized business growth consulting firm, as the “Global Leading Electric Two-wheeler Brand”.

Over the years, AIMA has always been a product trendsetter in the electric two-wheeler sector. As of March 31, 2024, the total sales volume of AIMA electric two-wheelers reached 80 million, and Frost & Sullivan, a world-renowned market consulting company, awarded AIMA with the market status certification of the “Global Leading Electric Two-wheeler Brand (by Sales)”.

AIMA adhere to the customer-centered product philosophy and technologies that support long-term innovation and breakthroughs. We believe that the efficiency and modern technology of the AIMA F-626 will present an excellent alternative means of communication for our customers.

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China Telecom Gulf Officially Launches in Saudi Arabia for Business

Published

3 hours ago

November 23, 2024

CISION (PR Newswire)

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HONG KONG, Nov. 23, 2024 /PRNewswire/ — On November 21, China Telecom Gulf was officially launched in Riyadh. This milestone marks a significant step in China Telecom’s efforts to provide deep services under the “Belt and Road Initiative” and to promote the building of a “China-Arab Community with a Shared Future.” It signifies another solid advancement on China Telecom’s path toward internationalization. Mr. Liu Guiqing, Executive Director and EVP of China Telecom Corporation, delivered an opening speech, along with Mr. Fawaz, Representative of Contact Office of Chinese Companies in the KSA, Deputy General Manager of Industrial and Commercial Bank of China Riyadh Branch. Over 100 guests and leaders from the Economic and Commercial Office of Embassy of the PRC of the KSA, Saudi Telecom Company (STC), Bank of China, Huawei, and others attended to witness this momentous occasion.

In his address, Mr. Liu Guiqing emphasized China Telecom’s commitment to openness, cooperation, and mutual benefit. He expressed the company’s willingness to share its experiences in cloud-network integration, cloud transformation, intelligent operations, and technological innovation. China Telecom aims to work closely with various levels of Saudi governments, enterprises, and partners to actively participate in the development of local digital infrastructure, drive the rapid advancement of next-generation information technologies, and establish a robust bridge for cooperation between China and Saudi Arabia in the field of information technology. Leveraging its extensive resources and global operational capabilities, China Telecom plans to bring its strengths in 5G, cloud computing, artificial intelligence, and other fields to provide innovative, high-quality communication products and services to Saudi enterprises, institutions, and consumers.

Mr. Fawaz extended his warm congratulations on the opening of China Telecom Gulf. He highlighted that as a leading global provider of communication services, China Telecom possesses abundant cloud-network resources and mature international service capabilities. The establishment of China Telecom Gulf is a significant step toward supporting the digital transformation of businesses in the region. He expressed confidence that through joint efforts, the company will seize opportunities in the digital era and contribute to Saudi Arabia’s socio-economic development and practical cooperation between China and Saudi Arabia in various fields.

China Telecom showcased its global resources, business capabilities, and its investments and partnerships in the Middle East and Africa. Key services introduced included eSurfing Cloud, computing power solutions, quantum technology, and customized 5G networks. Currently, China Telecom operates branches in 42 countries and regions worldwide, owns 53 international submarine cables, and manages 27 self-operated Internet Data Centers (IDCs). Its cloud-network integrated infrastructure and customer-centric digital service systems provide coverage across the globe.

During the event, China Telecom Gulf signed strategic cooperation agreements with Saudi Telecom Company (STC), Huawei Saudi Arabia, and Baud Telecom Company. The parties committed to deep collaboration, leveraging their respective strengths to provide optimized and convenient digital experiences to Saudi customers.

The establishment of China Telecom’s presence in Saudi Arabia marks a major milestone in the company’s entry into the Middle Eastern communications market, representing a key development in its global strategy. Moving forward, China Telecom Gulf will leverage China Telecom’s robust digital infrastructure and resource integration capabilities. We will collaborate closely with local Saudi enterprises, Chinese businesses expanding internationally, and global companies to strengthen cooperation and enhance exchanges. The company aims to contribute to the growth of Sino-Saudi and Middle Eastern industrial cooperation, continuously offering more smart solutions for the development of the Middle East’s digital economy, while striving to become a world-class provider of digital and intelligent technology services.

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Redefining Financial Frontiers: Nucleus Software Celebrates 30 Years with Synapse 2024 in Singapore

Published

18 hours ago

November 23, 2024

CISION (PR Newswire)

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SINGAPORE, Nov. 23, 2024 /PRNewswire/ — The thriving India–Singapore partnership in banking and technology reached a new milestone as Nucleus Software celebrated 30 years of transformative innovation at Synapse 2024, held in Singapore. The event underscored the company’s role in redefining financial services across Southeast Asia (SEA) and the globe, bringing together leaders in finance and technology to explore a shared vision for the future of banking.

Synapse 2024 celebrated 30 years of Nucleus Software’s leadership in driving transformative change across Singapore and Southeast Asia’s financial ecosystem. The event also shone a spotlight on the Global Finance & Technology Network (GFTN), an initiative supported by the Monetary Authority of Singapore (MAS) to champion responsible technology adoption. The event highlighted the deepening synergies between India and Singapore, driven by their shared commitment to innovation, cross-border collaboration, and financial inclusion. As the financial services sector undergoes rapid evolution with advancements in artificial intelligence, blockchain, and digital banking, these partnerships are setting the stage for a more connected, resilient, and inclusive global ecosystem.

Vishnu R. Dusad, Co-founder and Managing Director of Nucleus Software, reflected on the milestone: “For over 30 years, we’ve had the privilege of aligning our journey with Singapore’s ascent as a global financial powerhouse. Back in 1994, when we chose to go East instead of West, it was a bold and emotional decision—guided by our belief in Singapore as a hub for innovation and collaboration. We saw then what remains true today: Singapore is at the heart of the global financial landscape, a place where new ideas take root, and partnerships thrive.”

The event brought together a distinguished array of participants, highlighting the transformative potential of India–Singapore collaboration. Mr. Piyush Gupta, CEO of DBS Group and the Guest of Honor, set the tone for the event with his opening remarks, emphasizing the transformative role of big tech in reimagining scalable, customer-centric financial services in the digital age.

Following his address, key speakers enriched the discussions with their insights. Mr. Sopnendu Mohanty, Chief Fintech Officer at the Monetary Authority of Singapore and Group CEO-Designate of The Global Finance & Technology Network (GFTN), underlined the importance of fostering responsible technology adoption and building inclusive financial ecosystems. Mr. Vinod Rai, globally respected public policy expert, Distinguished Visiting Research Fellow at the National University of Singapore, and former Comptroller and Auditor General of India, shared his perspectives on governance and policy frameworks in financial systems. Mr. S.M. Acharya, Chairman of Nucleus Software and former Defence Secretary of India, offered a visionary outlook on leveraging technology to modernize and secure banking frameworks. Finally, Mr. Pieter Franken, Co-founder and Director of GFTN (Japan), a global FinTech pioneer and deep tech innovator, discussed the future of decentralized finance and its implications for the financial sector.

The event showcased the transformative role of technology in global financial systems, emphasizing innovations that set benchmarks for scalability and inclusivity. Panelists discussed the importance of localized solutions, the challenges of cross-border integration, and leveraging dual business models to optimize capital and foster public participation. The dialogue highlighted the need for common standards, unified frameworks like APIs, and collaborative efforts to accelerate financial inclusion and drive global connectivity in the digital age.

For 30 years, Nucleus Software has consistently introduced advanced lending and banking solutions that support financial institutions’ evolving needs in Singapore and South East Asia. Driven by lean development methodologies like Acceptance Test-Driven Development (ATDD) and Continuous Integration/Continuous Delivery (CICD), Nucleus Software continues to push boundaries in efficient, flexible, and secure financial technology.

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