Chagas Disease

TOKYO, April 22, 2025 /PRNewswire/ -- The Global Health Innovative Technology (GHIT) Fund announced today an investment of approximately JPY 679 million (USD 4.5 million1) for the development of diagnostics for tuberculosis, in addition to an investment of approximately JPY 15.9 million (USD 0.1 million1) for a drug discovery project for Chagas disease and leishmaniasis.2 Investment of approximately JPY 679 million ( USD 4.5 million 1 ) for the development of diagnostics for tuberculosis Tuberculosis (TB) remains a serious infectious disease, with approximately 10.8 million cases and 1.25 million deaths reported in 2023, making it the leading causes of death from a single infectious agent.3 The United Nations' Sustainable Development Goals (SDGs) set a target to end TB by 2030, but achieving this goal requires accurate and accessible diagnostic technologies. Current TB tests face challenges such as low sensitivity, high costs, complexity, and the need for specialized equipment and sputum samples, making them unsuitable for all patients. In particular, children, people with conditions who cannot produce sputum, and those in resource-limited settings often struggle to receive timely diagnoses, causing the continued spread of the disease. To address this issue, the GHIT Fund has decided to invest approximately JPY 679 million (USD 4.5 million1) towards a new TB diagnostic development project by US-based diagnostic developer Fluxus, Inc., 4 in partnership with Fujirebio, Inc., a developer of clinical diagnostics in Japan,4 and Heidelberg University Hospital in Germany. This project will leverage Fluxus' cutting-edge ultrasensitive detection technology to develop and validate a urine-based TB biomarker lipoarabinomannan (LAM) assay on its automated benchtop immunoassay analyzer. Additionally, the project will design and develop critical components for a portable, ultrasensitive point-of-care (PoC) system that integrates the urine LAM test. This advanced technology will enable rapid, accurate, and accessible diagnosis across a broader patient population, contributing to improved clinical outcomes and reduced transmission. In addition, the GHIT Fund will invest approximately JPY 15.9 million (USD 0.1 million1) in a screening project against Chagas disease and leishmaniasis by Kitasato University, Nagasaki University, University of Tokyo, and Drugs for Neglected Diseases initiative (DNDi). Please refer to Appendix 1 for detailed descriptions on these projects and their development stages. As of March 31, 2025, the GHIT Fund has invested in 36 projects, including 15 discovery projects, 12 preclinical projects, and 9 clinical trials.5 The total amount of investments since 2013 is JPY 38.2 billion (USD 255 million1) (Appendix 2). 1 USD1 = JPY149.53, the approximate exchange rate on March 31, 2025. 2 These awarded projects were selected and approved as new investments from among proposals to RFP2023-002 and RFP2024-001 for the Product Development Platform and the Screening Platform, which were open for applications from June 2023 to July 2024. 3 WHO: 4 Fluxus, Inc. and Fujirebio, Inc. are members of Fujirebio. 5 This number includes projects in the registration phase. The GHIT Fund is a Japan-based international public-private partnership (PPP) fund that was formed between the Government of Japan, multiple pharmaceutical companies, the Gates Foundation, Wellcome, and the United Nations Development Programme (UNDP). The GHIT Fund invests in and manages an R&D portfolio of development partnerships aimed at addressing neglected diseases, such as malaria, tuberculosis, and neglected tropical diseases, which afflict the world's vulnerable and underserved populations. In collaboration with global partners, the GHIT Fund mobilizes Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases. Appendix 1. Project Details ID: G2023-204 ID: S2024-122 *All amounts are listed at an exchange rate of USD1 = JPY149.53, the approximate exchange rate on March 31, 2025. Appendix 2. Investment Overview (as of March 31, 2025) Investments to date Total investments: 38.2 billion yen (USD 255 million1) Total invested projects: 136 (36 active projects and 100 completed projects) To learn more about the GHIT Fund's investments, please visit Investment Overview: Portfolio: Advancing Portfolio: Clinical Candidates: For more information, contact: Katy Lenard at +1-301-280-5719 or [email protected] Mina Ohata at +81-36441-2032 or [email protected] SOURCE GHIT Fund WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

TOKYO, March 17, 2025 /PRNewswire/ -- The Global Health Innovative Technology (GHIT) Fund announced today a total investment of approximately JPY 1.7 billion (USD 11.4 million1) in five projects for the development of schistosomiasis diagnostics and drugs for neglected tropical diseases (NTDs). 2 Investment total of approximately JPY 780 million ( USD 5.2 million 1 ) for the development of diagnostics for schistosomiasis Schistosomiasis is one of 21 NTDs that affects approximately 250 million people worldwide, with 90% of cases occurring in Africa. People become infected through contact with contaminated freshwater, allowing the parasite to penetrate their skin.. Among the five species of schistosomiasis causing the disease, two are widely distributed on the African continent: Schistosoma haematobium, which infects the urogenitary tract, and Schistosoma mansoni, which infects the intestines and liver. Current diagnostics face challenges such as low sensitivity and quality issues, making it difficult to accurately assess the infection status. To address this issue, the GHIT Fund had decided to invest approximately JPY 780 million (USD 5.2 million1) in two projects to develop new diagnostics for schistosomiasis led by Drugs & Diagnostics for Tropical Diseases, a nonprofit organization based in San Diego, California, USA, in collaboration with Medical & Biological Laboratories Co., Ltd., a Japanese manufacturer of clinical diagnostic kits and reagents, Nagasaki University Institute of Tropical Medicine, the Kenya Medical Research Institute, and the Noguchi Memorial Institute for Medical Research. The project will advance the development of a rapid diagnostic test (RDT) for Schistosoma mansoni, leveraging previous research findings and evaluating the diagnostic performance of the candidate RDT in endemic regions of Africa. In addition, the project team will develop a new serological RDT for Schistosoma haematobium. These tests are expected to be used as a low-cost, easy-to-use point-of-care (POC) diagnostic to support decision-making for Interruption of Transmission/Stopping Mass Drug Administration (MDA) and for subsequent surveillance of the disease. In addition, the GHIT Fund will invest in the following three R&D projects for a total amount of approximately JPY 932 million (USD 6.2 million1): 1) Phase I clinical trial project for dengue vaccine by VLP Therapeutics, Inc. and Nagasaki University. 2) Screening project against chikungunya by Medicines for Malaria Venture (MMV) and Eisai Co., Ltd. 3) Screening project against Chagas disease by Drugs for Neglected Diseases initiative (DNDi) and Shionogi & Co., Ltd. Please refer to Appendix 1 for detailed descriptions of these projects and their development stages. As of March 18, 2025, the GHIT Fund has invested in 35 projects, including 14 discovery projects, 12 preclinical projects and nine clinical trials.4 The total amount of investments since 2013 is JPY 37.5 billion (USD 251 million1) (Appendix 2). 1 USD1 = JPY149.63, the approximate exchange rate on February 28, 2025. 2 These awarded projects were selected and approved as new investments from among proposals to RFP2023-002 and RFP2024-001 for the Product Development Platform and the Screening Platform, which were open for applications from June 2023 to July 2024. 3 WHO: 4 This number includes projects in the registration phase. The GHIT Fund is a Japan-based international public-private partnership (PPP) fund that was formed between the Government of Japan, multiple pharmaceutical companies, the Gates Foundation, Wellcome, and the United Nations Development Programme (UNDP). The GHIT Fund invests in and manages an R&D portfolio of development partnerships aimed at addressing neglected diseases, such as malaria, tuberculosis, and neglected tropical diseases, which afflict the world's vulnerable and underserved populations. In collaboration with global partners, the GHIT Fund mobilizes Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases. Appendix 1. Project Details ID: G2024-202 ID: G2024-203 ID: G2023-201 ID: S2024-112 ID: S2024-121 *All amounts are listed at an exchange rate of USD1 = JPY149.63, the approximate exchange rate on February 28, 2025. Appendix 2. Investment Overview (as of March 18, 2025) Investments to date Total investments: 37.5 billion yen (USD 251 million1) Total invested projects: 136 (35 active projects and 101 completed projects) To learn more about the GHIT Fund's investments, please visit Investment Overview: Portfolio: Advancing Portfolio: Clinical Candidates: For more information, contact: Katy Lenard at +1-202-494-2584 or [email protected] Mina Ohata at +81-36441-2032 or [email protected] SOURCE GHIT Fund WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

DUBLIN--( BUSINESS WIRE )--The "CD39 Targeted Therapies Clinical Trials, Therapeutic Approaches & Market Opportunity Insight 2025" report has been added to ResearchAndMarkets.com's offering. CD39 targeting therapies are emerging as a promising strategy for modulating immune responses in a range of diseases. CD39 serves as a vital ectonucleotidase that influences the purinergic signaling pathway, thereby regulating the equilibrium between immune activation and suppression. By converting ATP into AMP, which is further transformed into adenosine by CD73, CD39 is instrumental in establishing an immunosuppressive microenvironment. This environment is particularly advantageous for tumors but also plays a role in chronic infections and autoimmune diseases. Inhibiting CD39 activity may restore immune functionality and enhance patient outcomes in these contexts. Report Highlights: First CD39 Targeted Therapy Approval Expected By 2029 CD39 Targeted Therapies In Clinical Trials: > 15 Therapies CD39 Inhibitors Clinical Trials Insight By Company, Country, Indication and Phase CD39 Targeted Therapy Research and Development Trends By Indication CD39 Targeted Therapies Proprietary Technologies Platforms By Company In the realm of oncology, the contribution of CD39 to immune suppression within the tumor microenvironment (TME) is well-established. Tumors frequently utilize the CD39-CD73-adenosine axis to evade immune surveillance, resulting in immune cell exhaustion and diminished anti-tumor responses. Elevated levels of CD39 on regulatory T cells (Tregs) and CD8+ T cells have been associated with unfavorable prognoses in various malignancies. By employing monoclonal antibodies that target CD39, such as IPH5201, it is possible to reactivate the immune system to more effectively combat tumor cells. IPH5201, which is being developed by Innate Pharma and AstraZeneca, is currently under investigation in conjunction with immune checkpoint inhibitors (ICIs) to enhance the immune response in patients with solid tumors. In addition to cancer, CD39-targeting therapies show considerable potential for addressing other diseases, particularly chronic viral infections, autoimmune disorders, and sepsis. In the context of chronic infections like HIV, tuberculosis, and Chagas disease, CD39 is implicated in immune exhaustion and suppression, which obstructs effective immune responses. By inhibiting CD39, there is a possibility of reversing immune dysfunction and improving the body's capacity to eliminate pathogens. In autoimmune disorders, where there is an overactivation of the immune system, the targeting of CD39 may aid in reestablishing equilibrium by enhancing the inhibitory function of regulatory T cells, which are vital for averting tissue damage. The therapeutic promise of targeting CD39 also encompasses sepsis, as CD39 expression on monocytes and macrophages is instrumental in regulating inflammation. In the context of sepsis, achieving a balanced immune response is crucial to mitigate tissue injury while effectively managing infection. By inhibiting the activity of CD39, therapeutic interventions could diminish excessive inflammation and restore immune homeostasis, presenting a novel strategy for addressing this critical condition. The clinical advancement of therapies aimed at CD39 is still in its nascent phase, with several candidates progressing through clinical trials, particularly in Phase 2. Among these, IPH5201 stands out as a leading candidate, demonstrating encouraging outcomes in both preclinical and early-phase clinical investigations. These antibodies are being assessed not only in oncology but also across a range of chronic conditions where CD39 plays a significant role in immune regulation. By focusing on CD39, these therapies seek to bolster immune responses in scenarios characterized by immune suppression or dysfunction. Looking forward, the potential uses of CD39-targeting therapies are extensive. The integration of anti-CD39 antibodies with other treatment modalities, such as immune checkpoint inhibitors or antiviral therapies, presents the opportunity for synergistic effects, thereby enhancing the immune response. Nonetheless, challenges persist, particularly concerning the context-dependent function of CD39 across various diseases and patient demographics. Achieving a precise balance between immune activation and suppression will be essential for the safe and effective implementation of these therapies. As clinical trials advance and additional data is collected, therapies targeting CD39 may emerge as a fundamental component of personalized medicine, effectively addressing various diseases through the precise and controlled modulation of immune responses. Key Topics Covered: Introduction To CD39 Targeting Therapies Role of CD39 & Emergence As Therapeutic Target Discovery of CD39 & Development Of Targeting Therapies CD39 Targeting Therapies Mechanism Of Action CD39 Inhibition CD39 Agonism Current CD39 Targeting Therapy Approaches Antibodies Nucleic Acid Therapeutics Small Molecule Inhibitors Global CD39 Targeted Therapies Clinical Trials Overview By Company By Indication By Country By Phase CD39 Targeted Therapies Clinical Trials Insight By Company, Country, Indication & Phase Research Preclinical Phase I Phase II Global CD39 Targeting Therapy Market Trends & Developments Current Market Outline Future Market Opportunities Role Of CD39 Targeting Therapies By Indication: Clinical Development & Collaborations Cancer Autoimmune & Inflammatory Diseases Cardiovascular Diseases Infections CD39 Targeted Therapies Technology Platforms OligoCreator & LNAplus Platforms - Secarna Pharmaceuticals Unnamed Platforms - Biotheus Unnamed Platform - Adimab OriAb Antibody Discovery Platform - Oricell Therapeutics TMAb Platform - Sensei Biotherapeutics Global CD39 Targeted Therapies Market Dynamics Market Drivers & Opportunities Market Challenges & Restraints Competitive Landscape Adimab Arcus Biosciences Biotheus BrightPath Biotherapeutics Elpiscience Biopharmaceuticals Innate Pharma Orega Biotech OriCell Therapeutics Secarna Pharmaceuticals Trishula Therapeutics For more information about this report visit https://www.researchandmarkets.com/r/pftdih About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.