National Taiwan University Hospital

CUPERTINO, Calif., Sept. 10, 2024 /PRNewswire/ -- Oneness Biotech and Microbio (Shanghai) announced that the pan-COVID New Drug, SNS812, co-developed by both companies achieves statistical significance with clinically meaningful endpoints in the Phase 2 trial. SNS812 has demonstrated good safety and efficacy in treating various virus strains including the currently prevalent strain JN.1 and many high immune-escape variants. Continue Reading Oneness Biotech and Microbio (Shanghai) announced that the pan-COVID New Drug, SNS812, co-developed by both companies achieves statistical significance with clinically meaningful endpoints in the Phase 2 trial. SNS812 is the only therapeutic with a broad-spectrum efficacy in multiple coronavirus variants. It has much more clinical advantages compared with Paxlovid, a Pfizer's drug with 70% market share. Dr. Shuling Cheng, the President of Oneness Biotech commented that this randomized, double-blind, placebo-controlled study was conducted at the National Taiwan University Hospital and 3 hospitals affiliated with Taipei Medical University (TMUH, Shuangho Hospital, and Wangfang Hospital) in compliance with the FDA's requirements. There were 3 cohorts with SNS812 200mg, SNS812 100mg and placebo respectively with a total of 135 subjects; 45 subjects in each group. The study results demonstrate that SNS812 inhalation was well supported by clean safety profile without any drug-related adverse events. Compared with the placebo group, SNS812 group achieves statistical significance in all target symptoms related to COVID-19 infection, including the time to sustained alleviation and resolution of fever, sore throat, shivers, headache, shortness of breath, nausea, vomiting, loss of smell and taste (P=0.007). The study results suggest a better outcome than other therapeutics in the global market. Dr. Shuling Cheng also points out that the genomic sequencing of the virus strains from all subjects demonstrates coverage of the latest prevalent genotypes, including JN.1, KP1-4, LB.1, BA.2, and XBB variants with 90% high immune-escape variants (JN.1、KP1-4 & LB.1). This also demonstrates that SNS812 is the only up-to-date COVID-19 new drug with broad-spectrum efficacy in the world. Dr. Yi-Chung Chang, the President of Microbio (Shanghai) commented that SNS812 treatment group achieves viral-negative earlier than the placebo group (P=0.018). The median time to achieve viral-negative in SNS812 200mg group was 2.9 days. SNS812 also significantly improved the loss of smell and taste related to the CNS system. Compared with the placebo group, SNS812 shows superior efficacy in alleviating or resolving the symptoms, including shortness of breath, fever, shivers, etc., which usually lead to severe COVID-19. Dr. Chang further explained that the current marketed COVID-19 therapeutics have side effects and the vaccines under development are lagged behind the evolution of the variants, which will not be effective. The SNS812 study readout is not only a great success for Oneness Biotech and Microbio (Shanghai), but also a worldwide medical breakthrough. According to the COVID-19 variants data published by the Centers for Disease Control and Prevention (CDC), new variants almost emerge every three months. Vaccine development falls behind the viral mutation. The U.S. government has initiated a project to incentivize the development of new therapies to address the issue of COVID-19 mutation variants. Globally, there is an urgent need for breakthrough solution to effectively treat or prevent the COVID-19 outbreak to the humanity. About Oneness Biotech Co., Ltd. (4743.TWO) Oneness Biotech was established in 2008 and went public in 2011. Oneness has been dedicated to research and development of game changing treatments and its key pipelines include Fespixon® new drug and Bonvadis® medical device for chronic wounds, FB825, the Anti-IgE B cells mAb out-licensed to global pharma for US$530 mn, and SNS812, the pan-COVID siRNA new drug of which phase 2 study achieves significant efficacy outcome. Oneness is committed to ESG and has been selected as an index component of the Dow Jones Sustainability Emerging Markets Index, included in the S&P Sustainability Yearbook 2023 and 2024, etc. It is also the only biotech company in Taiwan that received such ESG achievements. About Microbio (Shanghai) Co., Ltd. Microbio (Shanghai) is the subsidiary of Microbio Co., Ltd. in Taiwan and is also an important footprint in China for Microbio Group's. Microbio (Shanghai) has established its own core technology in nucleic acid new drugs by targeting viruses and bacteria. Multiple new drugs with first-in-class targets are under pre-clinical and clinical development. One of the breakthrough new drugs developed from this platform technology is SNS812, the pan- COVID siRNA new drug of which the phase 2 study achieves significant efficacy outcome with clean safety profile. With the success in the clinical trial, Global partnership will be the strategy for the next stage of SNS812's development. View the video for Pan-COVID New Drug – SNS812 Achieves Superiority in Phase 2 Study SOURCE Oneness Biotech

YONGIN, South Korea, July 21, 2024 /PRNewswire/ -- GC Cell Corporation (hereinafter referred to as "GC Cell"; 144510:KOSDAQ) and Lukas Biomedical Co., Ltd. (hereinafter referred to as "Lukas," TWSE 6814) has formally signed an international strategic cooperation agreement. GC Cell is a fully integrated pioneer in cell and gene therapy and a subsidiary of the renowned Korean-listed pharmaceutical group Green Cross Corporation, which has a market value of approximately 1.3 trillion Korean won (around 1 billion US dollars). Continue Reading This collaboration aims to increase awareness of autologous T cell therapy as well as to expand the patient access market through leveraging each other's strengths in innovative cell treatment areas. By sharing cutting-edge research projects, clinical trial data, regulatory knowledge across multiple countries, and exploring clinical research, market development, and various activities for cancers and other challenging diseases, both parties strive to accelerate drug development and establish a platform for precision medicine solutions. This partnership seeks to bring the benefits of innovative cell therapy to a wider range of patients. Having successfully completed clinical trials in Japan and Korea, GC Cell's Immuncell-LC autologous T cell therapy obtained approval from the Ministry of Food and Drug Safety (MFDS) in 2007 following favorable Phase IV trials. With a track record of over 10,000 treatment cases, GC Cell has been obtaining successful clinical and commercial records in Korea. Lukas's LuLym-T memory T cell cultivation technology originated from Japanese National Cancer Center and GC LTEC, formerly Lymphotec, a subsidiary of Green Cross Group. Based on the licensing agreement with originator of the technology and the tech transfer from the company, Lukas has brought this technology to Taiwan for market expansion and further enhancement. Taiwan's government has demonstrated significant commitment to the advancement of the regenerative medicine sector. Following the implementation of the Special Regulations on Regenerative Medicine, the Regenerative Medicine Act was enacted on June 4 this year. Lukas's LuLym-T cell therapy technology, supported by international clinical trials and evidence-based data generated by GC Cell, aligns closely with Taiwan governmental policies and regulations. It appears poised to secure a five-year conditional approval under the new regulations, thus establishing Lukas as a prominent player in Taiwan's cell therapy landscape, with a focus on domestic growth and global market expansion. Presently, Lukas has entered agreements with 13 medical institutions, including National Taiwan University Hospital, Chang Gung Memorial Hospital, and Taipei Veterans General Hospital, to conduct Phase II clinical trials focused on preventing liver cancer recurrence and exploring combined immunotherapy with chemotherapy/radiotherapy for head and neck cancer at Taipei Veterans General Hospital. Lukas' Chairman, Dr. Eric Tang, highlighted that GC Cell and Lukas will collaborate through a Joint Committee (JC) to exchange expertise and experience in researching memory T cell technology for various cancers in their respective countries. This collaboration involves sharing clinical and commercial knowledge, insights, and strategies, as well as exploring opportunities for cross-licensing and conducting joint clinical trials (IITs and SITs) in each other's regions. Moreover, they aim to discuss the opportunities to jointly explore new international markets, joint investment and beyond. James Park, CEO of GC Cell, stated, "This strategic cooperation agreement represents a pivotal milestone in accelerating the advancement of innovative cell therapies in Korea and Taiwan and also in establishing global network and ecosystem of Cell and Gene Therapy. Looking ahead, we are committed to accelerating the global expansion of Immuncell-LC through the continuous exchange of clinical research data and the establishment of a strong, long-term partnership between our two companies." Dr. Eric Tang, Chairman of Lukas stated that: "In addition to our clinical trial for preventing liver cancer recurrence, the Taiwanese government's implementation of the Special Regulations on Regenerative Medicine has allowed us to apply our LuLym-T cell technology on advanced stage cancer patients with various types of solid tumors. We have accumulated vast clinical experience in concomitant use of LuLym-T cell together with conventional treatment, such as: chemotherapy, radiotherapy, and checkpoint inhibitors. We are able to achieve significant prognostic improvements using a multi-modality treatment paradigm for advanced stage cancers and we hope we will be able to help more cancer patients in need by sharing our experience with other countries". This strategic cooperation represents a significant step toward a shared vision of improving patient outcomes through innovative cell therapies and precision medicine. About Immuncell-LC Immuncell-LC is the only commercially available treatment option of early-stage HCC. It is primarily composed of autologous, cultured blood-derived T lymphocytes with proven efficacy through a large-scale Phase 3 clinical trial which reduced the risk of recurrence by 37% and decreased the mortality rate by 79% compared to the control group. To date, Immuncell-LC has been administered to over 10,000 patients in South Korea without serious adverse events.  About GC Cell   With a core focus on cell therapy, GC Cell offers complete bio healthcare solutions from diagnosis to treatment, and the brand's comprehensive value chain spans R&D, production, commercialization, and distribution. More info: About Lukas Biomedical Lukas is dedicated to advancing its LuLym-T cell therapy R&D and clinical advancements, enhancing clinical trials and technologies, and expanding into foreign markets. Lukas has already attracted interest in Southeast Asia and is in talks and finalizing cooperation agreements with medical teams in the region. With a steady cash flow from its e-commerce business and hospital management platform, Lukas is well-positioned to expand its "LuLym-T" cell therapy business and, generating optimum value for shareholders and employees. SOURCE GC Cell

Biomedical engineers at RMIT University have built a smartphone feature that paramedics can use to immediately screen patients for stroke. In partnership with Brazil's São Paulo State University, RMIT University researchers developed an AI-powered tool for analysing facial symmetry and specific muscle movements, which are key signs of stroke. It is based on the Facial Action Coding System which categorises facial movements by the contraction or relaxation of facial muscles. The AI, in tandem with image processing tools, was tested on video recordings of facial expressions of 14 people with post-stroke and 11 healthy people. Based on findings published in the journal, Computer Methods and Programs in Biomedicine, the AI tool achieved 82% accuracy in detecting stroke "in seconds." The research team is now seeking collaborations with healthcare providers to turn their AI-driven smartphone feature into a mobile application. They are also considering expanding its use to detect other neurological conditions affecting facial muscles. WHY IT MATTERS Citing studies, Dinesh Kumar, an RMIT University professor who supervised the research, noted that 13% of stroke cases are missed in emergency departments and community hospitals, while 65% of cases are undiagnosed. Gender, race, and geographic location can also contribute to overlooking strokes, he added. "Given that many strokes occur at home and initial care is often provided by first responders in non-ideal conditions, there is an urgent need for real-time, user-friendly diagnostic tools." MARKET SNAPSHOT A similar innovation in mobile health was done in the United States in 2020 by Penn State University and Houston Methodist Hospital. Their machine learning-based tool also uses computational facial motion analysis, as well as natural language processing, to detect stroke-like symptoms, such as sagging muscles and slurred speech. Other AI-driven stroke risk assessment and detection capabilities are applied to brain scans, such as the recently approved NNS-SOT by Nunaps in South Korea and AICute by Chulalongkorn University researchers in Thailand. Meanwhile, in recent years, sensors that detect atrial fibrillation, an irregular heart rhythm that can cause stroke, have been increasingly incorporated into wearable devices, including Fitbit and Apple – both of which were cleared by the United States Food and Drug Administration. There are also mobile applications in Asia, such as the telemedicine app DrGo in Hong Kong and RhythmCam by the National Taiwan University Hospital, that have introduced a-fib detection functionalities.