Ewha Womans University

A consortium led by South Korea's top universities, Yonsei University and Seoul National University, will embark on a national project promoting the early detection of autism spectrum disorder in the country. Backed by the National Center for Mental Health and the Ministry of Health and Welfare, the project received 9.2 billion won ($6.6 million) in government funding. According to a media release, the project aims to develop AI-powered digital and medical devices for screening autism, which are targeted for release by 2028. The devices will be run by algorithms based on data from a cohort of 1,200 infants and toddlers below 48 months. Additionally, applications for an innovative medical device designation from the Ministry of Food and Drug Safety will be pursued. WHY IT MATTERS A recent article noted an overall increase in cases of ASD among Korean children and adolescents from 2011 to 2021. It has been estimated that the prevalence of DSM-5-defined ASD is at 2.20% . This trend may necessitate calibrating strategies to enable timelier and more effective prevention and care of children with autism. However, current approaches in ASD diagnosis, according to the Yonsei-SNU-led consortium, are largely dependent on specialists' findings and subjective observations of guardians, which often render them inconsistent and short of objectivity. "The AI-based [ASD] screening assistive medical device to be developed through this project will be an opportunity to shift the paradigm of early autism diagnosis and treatment," explained Chun Geun-ah, professor at Yonsei University Severance Hospital and principal project investigator. "The consortium will establish a foundation to overcome the limitations of diagnosing [ASD] and lead to better treatment outcomes," Kim Boong-nyeon, SNU Hospital (SNUH) professor and co-principal investigator, also said. The consortium involves several major hospitals, such as Yonsei's Gangnam Severance Hospital, Ewha Womans University Hospital in Seoul and Mokdong, and Seoul St. Mary’s Hospital, and digital health companies, including HurayPositive and Adotcure. THE LARGER TREND In 2023, SNUH opened a living laboratory to collect data that will be used to develop algorithm-driven models for detecting and personalising the treatment of ASD. The lab, also supported by the NCMH, serves as a bedrock for new digital therapeutics and the discovery of autism biomarkers. AI has seen increasing applications in ASD screening and treatment. EarliTec Diagnostics in the United States is a major developer in this space. It received regulatory approval for its autism decision support tool in 2022. Meanwhile, in Japan, new research utilised eye-tracking technology to demonstrate how predictable movement stimuli can be potentially used as a behavioural marker for autism .

** IND submitted to the FDA showing significantly improved patient condition when administered within 70 minutes of arrival at the Emergency Room ** *Multinational Phase 3 Clinical Trial protocols confirmed and initiated with leading global stroke research centers * SEOUL, South Korea, Dec. 11, 2024 /PRNewswire/ -- GNT Pharma Co. Ltd, a late-stage pharmaceutical company founded in 1998 with offices in Seoul Korea, Italy and USA, announced today the results of its latest Phase II ('SONIC') and Phase III ('Rodin') clinical trials study showing that stroke patients who received early administration of Nelonemdaz in combination with endovascular thrombectomy, demonstrated significant improvements in outcomes. These results were presented by Professor Jin Soo Lee, Chair of the Department of Neurology at Ajou University Medical Center at the recent International Conference Stroke Update 2024 (ICSU 2024). Dr BJ Gwag, Chairman and CEO of GNT Pharma commented "we are extremely encouraged with the SONIC and RODIN clinical trials results and excited to announce we have initiated multinational Phase 3 Clinical Trials (RENEW) with world class partners, including more than 20 top university hospitals in Korea as well as UCLA and UPMC Stroke Centers in the USA." Nelonemdaz is the world's first "multi-target" neuroprotection drug designed to reduce brain damage after a stroke or cardiac arrest. It offers superior efficacy compared to single-target neuroprotectants offering dual target action: (1) Inhibition of NMDA receptor subtype NR2B to safely reduce excitotoxicity; and (2) Removal of free radicals to reduce oxidative stress – two major causes of brain cell death following a stroke. Unlike non-selective NMDA receptor inhibitors, Nelonemdaz does not cause adverse effects and its safety has been verified in two Phase 1 trials, three Phase 2 trials, and two Phase 3 trials. There are over 5 million stroke-related deaths globally each year, with a further 5 million survivors annually left with permanent disabilities. This puts a huge strain on healthcare systems worldwide - the World Stoke Organization estimates total stroke-related costs to tip US$1 trillion by 2030. Moreover, stroke frequency is not abating, with the USA seeing an increase of 60% over the past 30 years. Almost 80% of all strokes are Ischemic Strokes and require emergency medical treatment, typically thrombolysis or endovascular thrombectomy. Given these alarming statistics, there is a global imperative to further improve the efficacy of current stroke treatments. Dr Gwag adds: "In 2015, fast endovascular thrombectomy was proven to improve functional outcome in acute ischemic stroke patients and is the de facto standard for stroke care across the world. It is therefore encouraging that the outcome of stroke patients is further improved by the fast administration of Nelonemdaz along with rapid thrombectomy," The prior Phase 2 SONIC trial results, published in Stroke Journal in 2022, showed the promising efficacy and safety of Nelonemdaz administered to stroke patients receiving thrombectomy. In the latest 498 patient Phase 3 RODIN Trial, administration of Nelonemdaz within 12 hours of ischemic stroke onset did not show significant efficacy in patients treated with thrombectomy. However, post-hoc analyses revealed potential interactions between treatment effects and time-related metrics. The RODIN results are to be published in the 'JAMA' (Journal of the American Medical Association) Network Open. The interactions were shown in the pooled analysis of stroke patients participating in the SONIC and RODIN trials, and in the subsequent subgroup analysis, the first infusion time of Nelonemdaz for improved functional outcome was established to be within 70 minutes from ER arrival. The efficacy of Nelonemdaz was assessed using the modified Rankin Scale (mRS), an ordinal scale ranging from 0 (normal) to 6 (death), at 12 weeks post-treatment. Compared to the placebo, the nelonemdaz caused a significantly beneficial shift in the mRS distribution (common odds ratio 2.2, p<0.05). The proportion of patients in mRS 0-2 corresponding to functional independence was 50.0% in the placebo group and improved to 68.6% in the Nelonemdaz group (p=0.059). Dr Lee adds " "Our post-hoc analyses unveiled a best clinical trial condition that showed a significant benefit of Nelonemdaz, and a protocol for the global phase 3 RENEW trial was established to confirm beneficial effects of Nelonemdaz in ischemic stroke patients in combination with endovascular thrombectomy." Dr. Lee will lead the RENEW trial alongside principal USA investigators Dr. Raul Nogueira, director of the UPMC Stroke Institute and Professor of Neurology and Dr. David S. Liebeskind, Director of the UCLA Stroke Center and Professor of Neurology. About GNT Pharma: GNT Pharma Co., Ltd ('GNTP') was founded in April 1998 by eight highly accomplished professors in subjects ranging from neuroscience and pharmacology to cell biology researching neuronal cell death. Since then, GNTP has discovered and developed an enviable pipeline of late stage drug candidates from nervous system disorders to chronic inflammatory diseases. As well as Nelonemdaz, GNTP's other flagship drug candidates include: Crisdesalazine for the treatment of Alzheimer's and neurodegenerative diseases and depression; and Flusalazine for inflammatory and respiratory diseases including COPD and Asthma. GNTP also has two commercial products in market, including Gedacure (Crisdesalazine) for the treatment of CDS or 'doggy dementia' that shares similar pathology to Alzheimers; and (2) Radipair, skin care products. Forward-Looking Statements Notice: This news release contains statements about expectations, plans, projections, and strategies of GNTP that constitute forward-looking statements to shareholders, investors, and partners. Statements included in this document that are not historical data and fact constitute forward-looking statements about future clinical and financial results. FURTHER INFORMATION: Media Inquiries: Byung Chul Kim, (M) +82-318005-9910; (E) [email protected] Investors/ Korea: Daeyong Kim, (M) +82-704261-0788; (E) [email protected] Investors /International: Sam Cho, (M) + 82-108948-7142; (E) [email protected] SOURCE GNT Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Pioneering Korea's ARPA-H Project: Focused on mRNA Vaccine Room-Temperature Storage and Extra-Long-Term Preservation Creating a Platform for Prolonged Room-Temperature Storage and Efficient Distribution of mRNA Vaccines SEOUL, South Korea, Nov. 1, 2024 /PRNewswire/ -- On October 30, a Korean Biotech company, DX&VX(; KOSDAQ 180400, Majority shareholder Lim Chong-yoon) announced its selection as a co-research institution for Korea's first ARPA-H project, titled "STOREx: Stockpile Technology to Omit Repeated Entity for Vx." This groundbreaking initiative aims to establish materials and production processes to enable room-temperature, ultra-long-term storage of mRNA vaccines. DX&VX will lead the verification of genomic integrity of the mRNA vaccine technology, a crucial step toward commercialization. Modeled after the U.S. ARPA-H initiative, the Korean ARPA-H project is managed by the Korea Health Industry Development Institute (KHIDI) and seeks to resolve major healthcare challenges through innovation. This specific project centers on advancing technology for the extra-long-term, room-temperature preservation of mRNA vaccines, thereby enhancing national health security and bolstering rapid pandemic response capabilities. Led by Professor Seung-Soo Oh from Pohang University of Science and Technology (POSTECH), the project includes a consortium of institutions: DX&VX, Korea University, Gwangju Institute of Science and Technology, Ewha Womans University, and Seoul Asan Medical Center. DX&VX will play a pivotal role in both technology validation and subsequent commercialization of this critical vaccine storage solution. This project has secured a significant research fund of 8.5 billion KRW over five years, with an allocation breakdown of 1.5 billion KRW for the initial phase, 5 billion KRW for the second phase, and 2 billion KRW for the final phase. Having previously collaborated with POSTECH on mRNA vaccine advancements, including lipid nanoparticle (LNP) technology, DX&VX will now concentrate on enabling room-temperature storage and extra-long-term preservation for mRNA vaccines. Given that current mRNA vaccines require ultra-cold storage and have limited shelf lives, these advancements are expected to ease distribution challenges, reduce costs, and foster a self-reliant national healthcare system, thus ensuring vaccine sovereignty in the face of future health crises. "We will play a pivotal role in this project based on our expertise accumulated in the field of precision medicine, such as genomic integrity analysis technology", said Kevin Kwon, CEO of DX&VX. "The development of mRNA vaccine's room temperature extra-long-term preservation technology and mass production process technology is the best innovative technology that can change the game itself in the existing mRNA vaccine market. We will actively commercialize this technology to lead the development of domestic vaccines and grow it into a standard for the global mRNA vaccine platform." SOURCE Dx&Vx WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED