Toripalimab

TAICHUNG, Feb. 5, 2025 /PRNewswire/ -- Healthcare Expo Taiwan is a professional-oriented exposition involving healthcare, information/communication, technology, biopharmaceutical and medical device industries. Attended by healthcare professionals from all over the world, the Expo showcases the latest developments and trends in healthcare technology in Taiwan. China Medical University (CMU) and Healthcare System unveiled groundbreaking advancements in AI-driven drug discovery and cancer therapy at the latest 8th Healthcare Expo. These achievements cement CMU and Healthcare System's position as a global leader in healthcare innovation, setting new benchmarks for the biomedical industry. Continue Reading CMU and Healthcare System (Taiwan) highlights groundbreaking AI-driven drug discovery and unveils the latest advancements in healthcare innovations and their clinical applications. Dr. Chang-Hai Tsai, Chairman of CMU and Healthcare System, emphasized the institution's commitment to cutting-edge research and international collaboration. By partnering with Kyoto University, CMU and Healthcare System has established a global research center to spearhead advancements in cancer research, regenerative medicine, and AI-powered drug discovery. A Milestone in Cancer Therapy: Allogeneic CAR-T Achieves 90% Tumor Reduction CMU and Healthcare System revealed the world's first allogeneic CAR-T therapy for solid cancers, developed by Ever Supreme Bio Technology. This therapy has demonstrated an unprecedented tumor reduction rate of over 90% in pre-clinical studies. Human clinical trials are underway, with FDA approval marking a pivotal moment in solid tumor treatment. Precision Medicine Breakthroughs: Exosome Technology and AI Integration Shine-On Biomedical and Shine Out Bio Technology are revolutionizing precision medicine through exosome technology. Their innovations include: SOA101 Trispecific Antibody: A nanobody-based platform combining two immune checkpoint inhibitors, now in FDA-reviewed Phase I/IIa trials for cancer therapy. SOB100 HLA-G Targeted Exosome: Delivering drugs with pinpoint precision to tumors, this platform enhances efficacy while minimizing side effects. Human clinical trials for these technologies are set to begin in 2025, promising to transform cancer and neurodegenerative disease treatments. AI-Powered Healthcare Solutions CMU and Healthcare System's AI-driven initiatives include: Child Growth Assessment System: AI generates detailed diagnostic reports for personalized treatment planning. HiThings Tele-ICU: This state-of-the-art system integrates real-time patient data with 3D modeling for enhanced critical care management. Smart Health Scheduling: AI optimizes health examination processes to streamline care delivery. Computer-assisted detection platform for Tc-99mTRODAT-1: AI analyzes brain images and visual scales to assist in diagnosing central nervous system motor disorders. Long Term Care Record System and Medical Information Revise Assistant (MIRA): Enhances medical record accuracy and efficiency, allowing healthcare professionals to focus on patient care. Specialized Healthcare Innovations CMUH continues to lead in cutting-edge treatments: MRgFUS for Parkinson's Disease: A non-invasive, MRI-guided therapy offering new hope for patients. Proton Therapy Center: Delivering precision cancer treatments with reduced side effects. Gout Risk Prediction: Genetic testing for tailored patient management. Global Collaboration with Kyoto University The newly established CMU-Kyoto University Global Research Center strengthens ties in cancer research, translational medicine, and regenerative therapies. As part of this initiative, CMU Research Park integrates academic and industrial expertise to drive groundbreaking developments from laboratory research to clinical applications. Advancing Healthcare Through Innovation Dr. Der-Yang Cho, Superintendent of CMUH, highlighted AI's transformative role in drug discovery and clinical applications. CMU and Healthcare System remains at the forefront of healthcare innovation, bridging AI, biotechnology, and clinical practice to redefine the future of medicine. CMU and Healthcare System's pioneering work at the Healthcare Expo Taiwan underscores Taiwan's growing influence in global healthcare. With a focus on collaboration and innovation, CMU and Healthcare System is not just shaping the future of medicine—it's leading it. Contact Carolyn Chen [email protected] SOURCE China Medical University Hospital WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

This study will evaluate HCW9302 in patients with moderate to severe alopecia areata MIRAMAR, Fla., Feb. 03, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” or the “Company”) (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies to extend healthspan by targeting the link between chronic inflammation and disease, today announced that it has received clearance of its Investigational New Drug Application (“IND”) from the U.S. Food and Drug Administration (“FDA”) to initiate a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, in patients with moderate-to-severe alopecia areata, a common autoimmune disease in humans that currently has no curative FDA approved treatments. Alopecia areata causes sudden hair loss and can have a significant negative impact on patients’ quality of life and psychological health. HCW9302 is an injectable, first-in-kind interleukin 2 (“IL-2”) fusion protein complex constructed using the Company’s proprietary TOBI platform technology. Its mechanism of action involves binding to IL-2αβγ receptors predominantly expressed on regulatory T (“Treg”) cells, thereby activating and expanding Treg cells that can suppress unwanted immune and inflammatory responses. Chronic inflammation is believed to be a significant contributing factor in many diseases and conditions including those that have a major impact on quality-of-life but are not life-threatening. In multiple relevant preclinical models, HCW9302 has shown efficacy in treating autoimmune diseases at well-tolerated dose levels by activating and expanding Treg cells through subcutaneous injections. Protein-based therapies, whether as direct inhibitors or immunomodulatory agents, have revolutionized the management of autoimmune and inflammatory conditions. The Company believes that HCW9302, with its subcutaneous injectable approach, has the potential to activate and expand Treg cells in patients, reducing inflammation, while minimizing the risk of broad immunosuppression. Dr. Hing C. Wong, Founder and CEO of HCW Biologics, commented, “The FDA’s clearance to initiate our first-in-human clinical trial for HCW9302 brings us one step closer to advancing a potentially transformative immunotherapeutic treatment of autoimmune diseases. This trial is a milestone for our Company, and the beginning of clinical development of treatments for quality-of-life indications. While not life-threatening, alopecia areata has no cure. Existing off-label treatments may provide some relief of symptoms, but there are often dangerous side effects. For those who suffer from this disease, it can negatively impact their quality-of-life.” Dr. Wong continued, “The goal of this initial trial is to establish the safe dose of HCW9302 that effectively increases Treg cells activity in patients. Once we achieve this objective, we will rapidly expand clinical development of HCW9302 in Phase 2 studies in patients with other autoimmune diseases and inflammatory conditions, including other dermatological conditions, graft rejection, arthrosclerosis, diabetes, and neurodegenerative diseases where HCW9302 has been shown to have activity in relevant animal models.” About Alopecia Areata: Alopecia areata (“AA”) is one of the most prevalent autoimmune diseases in the world, affecting approximately 1 in 1,000 people, with a lifetime incidence of 2% worldwide, or 160 million people. According to the National Alopecia Areata Foundation (NAAF), about 7 million people in the United States have alopecia areata. The condition primarily affects individuals under the age of 30, occurring at similar rates in both males and females. AA is characterized by hair loss in localized areas, the entire scalp, or, in some cases, the whole body. It occurs when the immune system mistakenly attacks hair follicles, leading to hair loss without causing permanent damage to the follicles. Patients often experience recurring episodes of hair loss throughout their lives. Existing treatments, such as corticosteroids, immunotherapy, Janus kinase inhibitors, and topical solutions, focus on managing the severity and duration of episodes of hair loss. However, these therapies primarily address symptoms rather than providing a cure or consistent, long-term hair regrowth. Currently, there is no cure for alopecia areata. About HCW Biologics: HCW Biologics Inc. (NASDAQ: HCWB) is a clinical-stage biopharmaceutical company developing proprietary immunotherapies to treat diseases promoted by chronic inflammation, especially age-related and senescence-associated diseases. The Company’s immunotherapeutics represent a new class of drug that it believes have the potential to fundamentally change the treatment of cancer and many other diseases and conditions that are promoted by chronic inflammation — and in doing so, improve patients’ quality of life and possibly extend longevity. Chronic inflammation, including inflammaging, is believed to be a significant contributing factor to the cause for senescence-associated diseases and conditions that diminish healthspan, including many types of cancer, autoimmune diseases, and neurodegenerative diseases, as well as indications that impact quality-of-life that are not life-threatening. The Company’s lead product candidate, HCW9302, was developed using the Company’s legacy TOBI™ (Tissue factOr-Based fusIon) platform. The Company has created another drug discovery technology, the TRBC platform, which is not based on Tissue Factor. The TRBC platform has the capability to construct immunotherapeutics that not only activate and target immune responses but are also equipped with receptors that specifically target cancerous or infected cells. This platform is such a versatile scaffold that it enables the creation of multiple classes of immunotherapeutic compounds: Class I: Multi-Functional Immune Cell Stimulators; Class II: Second-Generation Immune Checkpoint Inhibitors; Class III: Multi-Specific Targeting Fusions and Enhanced Immune Cell Engagers. These novel immunotherapeutics can be used to treat a wide range of disease indications, including oncology, autoimmune diseases, and improving quality of life conditions. The Company has constructed over 30 molecules using the TRBC platform, including HCW11-002, HCW11-018 and HCW11-027. Further preclinical evaluation studies are currently being conducted for these three molecules the Company has selected based on promising early data. The Company has two licensing programs in which it has licensed exclusive rights for some of its proprietary molecules. See the Company Pipeline at https://hcwbiologics.com/pipeline/. Forward Looking Statements: Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words and include, the Company’s ability to develop new immunotherapeutic treatments for auto-immune indications; the Company’s ability to enter into agreements with clinical sites to participate in the study; the successful initiation of a clinical trial; the Company’s ability to enroll the required number of patients for the study; that the clinical study will proceed with no adverse effects to any patients participating in the trial; that the study will not be put on a clinical hold by the FDA for any reason; and that the clinical study will reach its endpoints successfully; the efficacy of HCW9302 for autoimmune conditions; and the ability of HCW9302 to activate and regulate Treg cells in patients. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties that are described in the section titled “Risk Factors” in the annual report on Form 10-K/A filed with the United States Securities and Exchange Commission (the “SEC”) on May 15, 2024, the latest Form 10-Q filed with the SEC on November 14, 2024, and in other filings filed from time to time with the SEC. Company Contact: Peter Rhode, PhD. Vice President of Clinical Operations and Chief Scientific Officer HCW Biologics Inc. peterrhode@hcwbiologics.com