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HONG KONG, March 21, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) presented promising phase III safety run-in results from the COMPASSION-18/AK104-305 study, at the 2025 Annual Meeting of the Society of Gynecologic Oncology (SGO). The study evaluates the global first-in-class PD-1/CTLA-4 bispecific antibody, cadonilimab (AK104), in combination with concurrent chemoradiotherapy (CCRT) for the treatment of locally advanced cervical cancer. Currently, CCRT is the standard of care for locally advanced cervical cancer, but approximately 30%-40% of patients experience relapse or disease progression within five years. Cadonilimab, with its unique dual-target mechanism, is designed to simultaneously inhibit the PD-1 and CTLA-4 immune checkpoint pathways. It has received approval from the National Medical Products Administration (NMPA) in China for use in patients with recurrent or metastatic cervical cancer who have failed prior platinum-based chemotherapy. The Phase III COMPASSION-16 study further confirmed that cadonilimab, when combined with platinum-based chemotherapy (with or without bevacizumab), significantly improves progression-free survival (PFS) and overall survival (OS) in patients with persistent, recurrent, or metastatic cervical cancer. Based on these compelling results, the supplemental New Drug Application (sNDA) for cadonilimab as a first-line treatment for persistent, recurrent, or metastatic cervical cancer is currently under regulatory review. At this year's SGO, data from the COMPASSION-18 study highlighted the exceptional efficacy seen in patients receiving cadonilimab in combination with CCRT during the safety run-in phase. The results demonstrate the considerable therapeutic potential of cadonilimab combined with CCRT for locally advanced cervical cancer. The study included a more challenging patient cohort, with a notably higher proportion of patients having PD-L1 CPS <1 (38.2%) and an ECOG performance status of 1 (52.9%) compared to other similar studies. Overall Response Rate (ORR): The evaluable patients achieved a remarkable ORR of 100%, with a complete response (CR) rate of 84.8% and a partial response (PR) rate of 15.2%, which significantly outperformed data from other comparable studies. The median duration of response (DoR) has yet to be reached. Progression-Free Survival (PFS): While the median PFS has not been reached, the 12-month PFS rate was 74.9%. Subgroup Analysis: Patients with PD-L1 CPS ≥1, ECOG 0, and those not infected with COVID-19 derived even greater benefit from the treatment, with 12-month PFS rates of 85%, 87.5%, and 81.3%, respectively. Safety Profile: Cadonilimab combined with CCRT exhibited a favorable safety profile, demonstrating good tolerability and manageable adverse events. Notably, there were no treatment-related deaths (TRAE) and no new safety concerns were identified. Cadonilimab is making significant progress in treating both recurrent/metastatic and locally advanced cervical cancer, establishing a comprehensive therapeutic approach. The positive results from the COMPASSION-18 study reinforce its potential in a broader patient population. As clinical development continues, cadonilimab is set to redefine cervical cancer treatment, offering long-term survival benefits to more patients.
SEONGNAM, South Korea, March 20, 2025 /PRNewswire/ -- LISCure Biosciences Inc. ("LISCure") announced on the 2025 Feb that it has received approval from the Korean Ministry of Food and Drug Safety (KMFDS) for Mobiome®, a proprietary probiotic ingredient developed to promote hair health. Securing this regulatory approval from KMFDS highlights LISCure's strong research and development capabilities and technological expertise. This marks the world's first scientifically validated probiotic ingredient for hair health with plans for both domestic and global commercialization. Mobiome®, developed using LISCure's proprietary technology, has demonstrated significant efficacy in preclinical models, enhancing antioxidant activity and exhibiting anti-inflammatory effects. Mechanistic studies further confirmed its ability to stimulate follicular cell proliferation and regulate follicular cell cycles. In human clinical trials, Mobiome® showed statistically significant improvements in hair glossiness, elasticity, and overall user satisfaction (p<0.05, 95% confidence level) across multiple hair-related parameters, including texture, split ends, dryness, breakage, tangling, and damage. Previously, hair care solutions were limited to pharmaceuticals and topical products such as shampoos. With this regulatory expansion, the hair health market is expected to experience significant growth both domestically and internationally. According to global market research firm Research and Markets, the global hair growth supplement market is projected to grow at a compound annual growth rate (CAGR) of 14.7% from 2023 to 2030, reaching an estimated market value of $1.92 billion (approximately KRW 2.7 trillion) by 2030. LISCure is actively developing functional ingredients targeting hair health, joint health, mental health, weight management, and kidney health, etc. In parallel with its functional ingredient business, LISCure is accelerating its global pharmaceutical initiatives. The company has initiated patient dosing for LB-P8, a liver disease treatment that has received IND approval for Phase 2 clinical trials, as well as Orphan Drug designation and Fast Track designation in the U.S. Additionally, LISCure is advancing the joint commercialization of its brain shuttle platform, Exo-Pass N, in collaboration with global pharmaceutical partners. The company is also expediting the development of immuno-oncology therapies targeting colorectal and pancreatic cancers. Leveraging the anticipated success of its global drug pipeline and growing revenue from functional ingredients, LISCure is preparing for an initial public offering (IPO). While prioritizing its core pharmaceutical R&D and technology licensing business, the company aims to establish a stable and sustainable revenue model through its functional health ingredient segment. Hwa-Sup Chin, CEO of LISCure Biosciences, stated, "Securing the world's first regulatory approval for a hair health probiotic is a major milestone in our R&D efforts. By leveraging our proprietary platform technologies, we will continue expanding our pipeline beyond pharmaceuticals to include innovative functional health ingredients. Our strategy is to optimize the balance between therapeutics licensing deal with global big pharma and functional ingredient sales to strengthen our global competitiveness."
- Presented a roadmap to enhance screening reliability at the world's leading multidisciplinary HPV congress held in Portugal from March 16-19- Demonstrated how self-collected samples for HPV testing can bridge gaps in cervical cancer screening and advance HPV screening goals SEOUL, South Korea, March 20, 2025 /PRNewswire/ -- Seegene Inc., a global leader in total solution for PCR molecular diagnostics, presented its high-precision Human Papillomavirus (HPV) screening and full genotyping solutions at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) 2025 in Porto, Portugal from March 16-19. Seegene showcases its flagship HPV diagnostic product lineup and presents its HPV genotyping solution at EUROGIN 2025 in Portugal from March 16-19 (CET). The company showcased its expertise through an exhibition booth under the theme "Elevating Confidence in HPV Screening" and hosted symposium programs to emphasize accurate identification of high-risk HPV types related to cervical cancer is critical. Seegene's advanced solution enhances diagnostic accuracy, enabling timely and effective detection. Seegene presented its flagship HPV diagnostic product lineup that are designed to simultaneously detect HPV genotypes responsible for cervical cancer and/or HPV-related cancer. This capability is crucial in identifying high-risk HPV types that are known to cause cervical cancer and detecting other genotypes that are associated with benign tumors. At the Seegene symposium on March 16, leading clinical experts from Europe discussed strategies for integrating HPV testing into real-world clinical practice. The symposium underscored the critical role of HPV testing in the early detection of cervical cancer. Additionally, the experts highlighted the advantages of self-sampling, a method that enables individuals to collect their own samples. This approach not only streamlines the testing process but also promotes the broader adoption of HPV screening. "Seegene's HPV testing solutions are designed to deliver accurate diagnostics and reliable testing capabilities in real-world clinical environments," said Daniel Shin, Executive Vice President and Chief Global Sales & Marketing Officer at Seegene. Seegene's annual participation in EUROGIN is a testament to its commitment to advancing HPV screening and genotyping for the accurate diagnosis and prevention of cervical cancer. In July 2024, the company also took part in the Asia-Oceania Research Organization on Genital Infection and Neoplasia (AOGIN) 2024 held in Seoul. According to the World Health Organization (WHO), Cervical cancer is the fourth most common cancer among women worldwide and the second leading cause of cancer-related deaths. In 2018, the WHO launched the 90-70-90 campaign to eliminate cervical cancer. The targets aim to achieve 90% HPV vaccination coverage among girls by the age of 15; 70% of women screened using high-performance tests by the age of 35 and 45; and treatment for 90% of women identified with pre-cancer and invasive cancer by 2030. About Seegene Seegene has more than 20 years of dedicated experience in R&D, manufacturing, and business related to syndromic real-time PCR technologies. This expertise was particularly highlighted during the COVID-19 pandemic when Seegene provided over 340 million COVID-19 tests to more than 100 countries worldwide. The core feature of Seegene's syndromic real-time PCR technology is the ability to simultaneously test for 14 pathogens that cause similar symptoms in a single tube with quantitative information. Visit: Seegene.com and follow linkedin.com/company/seegene-inc
SEOUL, South Korea, March 20, 2025 /PRNewswire/ -- Harvest Integrated Research Organization (HiRO), a boutique global CRO, is pleased to announce the signing of a Memorandum of Understanding (MOU) with Hallym University Sacred Heart Hospital in Seoul, South Korea. This strategic alliance aims to drive innovation in drug research and development while strengthening collaboration across the medical and research sectors. Prof. Hyung-soo Kim, Director of Hallym University Sacred Heart Hospital (left), and Dr. Karen Chu, Founder and CEO of HiRO (right), signed the MOU, marking a significant milestone in the collaborative efforts of both organizations. The collaboration outlines shared objectives focused on fostering innovation in health and health technology, accelerating drug research and development, and enhancing the efficiency of clinical trials, all while upholding the highest standards of quality and care. By uniting efforts, HiRO and Hallym University Sacred Heart Hospital are well-positioned to make significant progress in improving healthcare outcomes and addressing unmet clinical needs for patients in South Korea and beyond. Hallym University Sacred Heart Hospital, equipped with cutting-edge facilities and a highly skilled team of medical professionals, specializes in various therapeutic areas and is fully capable of conducting clinical trials ranging from early to late stages in accordance with ICH-GCP guidelines. In turn, HiRO will leverage its extensive global experience and strong presence in the US, Europe, and Asia-Pacific regions to optimize clinical research efficiency, and proactively introduce multiregional trials to South Korea and the hospital. Dr. Karen Chu, Founder and CEO of HiRO, remarked, "Hallym University Sacred Heart Hospital's robust clinical trial capabilities, combined with HiRO's extensive experience and our global leadership team's expertise, averaging 20 years in the field, will streamline workflows and accelerate timelines, ensuring the effective delivery of pioneering treatments to the market. This partnership not only seeks to drive innovation but also to cultivate international collaborations that will lead to meaningful advancements in medical research on a global scale. Prof. Hyung-soo Kim, Director of Hallym University Sacred Heart Hospital added, "This agreement symbolizes a remarkable opportunity to provide patients with more innovative treatment options. By integrating our clinical research capabilities with HiRO's global network, we aim to create a transformative collaboration model that bridges medical practice, research, and industry." Through this agreement, both HiRO and Hallym University Sacred Heart Hospital are set to establish a partnership that strives for mutual success in clinical research and delivering more effective treatments, consequently enhancing health outcomes for patients both locally and globally. About Harvest Integrated Research Organization (HiRO) Harvest Integrated Research Organization (HiRO) is a globally oriented, innovative clinical research organization (CRO). With global operations and integrated capabilities, HiRO provides a full range of cross-border solutions and services to its clients, including early pre-clinical strategic planning, clinical trial design, regulatory affairs, pharmacovigilance, statistics, data management, end-to-end project management, and clinical and medical monitoring services. As an emerging global CRO, HiRO strives to become a market-leading, integrated global clinical research organization that works collaboratively with biotech and pharmaceutical companies to bring new products from the laboratory to the market, providing more effective solutions for patients worldwide. For more information, please visit www.harvestiro.com. About Hallym University Sacred Heart Hospital Hallym University Sacred Heart Hospital, founded in January 1999, is a renowned tertiary hospital located in Seoul, Korea, dedicated to delivering outstanding healthcare services. The hospital is celebrated for its exceptional faculty and state-of-the-art medical technology, creating a patient-centered environment that prioritizes the health and satisfaction of every individual it serves. Specializing in multidisciplinary, integrated care, Hallym University Sacred Heart Hospital excels in treating severe and acute conditions while driving medical innovation through the Doheon Digital Medical Innovation Research Institute. This institute focuses on advancements in AI, Big Data, and robotics to enhance healthcare delivery and improve patient outcomes. For more information, please visit https://eng.hallym.or.kr/.
SHANGHAI, March 19, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announced its 2024 Annual Results. Business Highlights Zevor-cel was approved by China's National Medical Products Administration (NMPA). As of December 31, 2024, certification and filings for zevor-cel completed in 23 provinces or cities, covering over 200 healthcare institutes; CARsgen has received a total of 154 valid orders from its commercialization partner Huadong Medicine. Satri-cel ST-01 confirmatory Phase II trial for gastric cancer in China: enrollment has been completed, and the study has met its primary endpoint. Satri-cel received BTD designation from CDE of China NMPA. CARsgen plans to submit a New Drug Application (NDA) to the China NMPA during the first half of 2025. Results from the investigator-initiated trial (IIT) of satri-cel were published in Nature Medicine and at the 2024 ASCO Annual Meeting. The results of the IIT of an allogeneic BCMA-targeting CAR-T product CT0590, which deploys the THANK-uCAR® technology platform, were presented at the 2024 ASH Annual Meeting. Developed THANK-u Plus™ platform as an enhanced version of THANK-uCAR® allogeneic CAR-T platform. Multiple allogeneic CAR-T products in development, covering treatment areas such as hematologic malignancies, solid tumors, and autoimmune diseases. Introduced Zhuhai SB Xinchuang to accelerate allogeneic CAR-T development in mainland China. Cash and bank balances were around RMB1,479 million as of December 31, 2024. Cash and cash equivalents and deposits at the end of 2025 are expected to be not less than RMB1,080 million. Expect to have adequate cash into the 2028. "In 2024, CARsgen achieved its first drug commercialization and made remarkable progresses in key pipeline products and technological innovations. Looking ahead, we will continue developing innovative CAR T-cell therapies to address the significant unmet medical needs," said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics. CARsgen Pipeline Zevor-cel: Approved by the NMPA and Launched in China Zevorcabtagene autoleucel (zevor-cel, R&D code: CT053) is an autologous fully human CAR T-cell product against B-cell maturation antigen (BCMA). On February 23, 2024, zevor-cel was approved by China's NMPA for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have progressed after at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent). CARsgen entered into a collaboration agreement with Huadong Medicine for the commercialization of zevor-cel in mainland China. As of December 31, 2024, certification and regulatory filings for zevor-cel have been completed in 23 provinces or cities, covering over 200 healthcare institutes and we have received a total of 154 valid orders from Huadong Medicine. Updated results of the pivotal Phase II registrational trial of zevor-cel in China were reported as an oral presentation at the 29th European Hematology Association (EHA) Annual Congress, and a subgroup analysis was presented a poster at the 66th ASH annual congress. We anticipate that growth of sales revenue of zevor-cel will further accelerate with continuous marketing activities and broader insurance coverage. Satri-cel: Confirmatory Phase II trial Met Primary Endpoint, Plans to Submit an NDA Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be first-in-class globally. Satri-cel targets Claudin18.2 positive solid tumors with a primary focus on gastric cancer/gastroesophageal junction cancer (GC/GEJ) and pancreatic cancer (PC). Patient enrollment has been completed in confirmatory Phase II trial in China (NCT04581473) in advanced GC/GEJ. The study has met its primary endpoint of a statistically significant improvement in progression-free survival (PFS) as assessed by the Independent Review Committee (IRC). Patients treated with satri-cel infusion achieved statistically significant improvement in PFS compared to those treated with physician's choice (paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab). Based on the confirmatory Phase II clinical data, satri-cel has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China NMPA. CARsgen plans to submit an NDA to the NMPA in China during the first half of 2025. Satri-cel is expected to become the world's first CAR-T therapy for solid tumors to be approved for market. Updated results from the investigator-initiated trial (CT041-CG4006, NCT03874897) were published in Nature Medicine in June 2024 and presented orally at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in June 2024. Additionally, more research findings have been published in prestigious academic journals such as the Journal of Clinical Oncology and the Journal for ImmunoTherapy of Cancer. A Phase I clinical trial for PC adjuvant therapy (CT041-ST-05, NCT05911217), and an investigator-initiated trial for GC/GEJ adjuvant therapy (CT041-CG4010, NCT06857786) are ongoing in China. Advancing the Development of Allogeneic CAR-T Products In addition to autologous products, CARsgen has also been advancing differentiated allogeneic CAR T-cell products utilizing the proprietary THANK-uCAR® platform. CARsgen has recently developed the THANK-u Plus™ platform as an enhanced version of its proprietary THANK-uCAR® allogeneic CAR-T technology to address the potential impact of NKG2A expression levels on therapeutic efficacy. The results of the IIT proof-of-concept study of an allogeneic BCMA-targeting CAR T-cell product candidate CT0590, which deploys the THANK-uCAR® technology platform, were presented as a poster at the 66th ASH Annual Meeting in December 2024. The data indicates that CT0590 has achieved a DoR of over 20 months in patients with sCR, with a peak CAR copy number exceeding 280,000 copies/µg gDNA, which is comparable to autologous BCMA CAR-T therapies, preliminarily demonstrating the durability of its efficacy. In addition, there are several universal CAR-T products under development, covering areas such as hematologic malignancies, solid tumors, and autoimmune diseases: CT059X: Targeting BCMA, for the treatment of R/R MM and R/R PCL. The first patient in the IIT achieved sCR at the Day-28 assessment. KJ-C2219: Targeting CD19/CD20, for the treatment of B-cell malignancies, as well as SLE and SSc. The IITs are ongoing. KJ-C2320: Targeting CD38, for the treatment of AML. The IIT is ongoing. KJ-C2114: For the treatment of solid tumors. KJ-C2526: Targeting NKG2DL, for the treatment of AML, other malignancies, and senescence. On February 25, 2025, CARsgen announced reaching agreements with an investment fund managed by Zhuhai Hengqin SB Xinchuang Equity Investment Management Enterprise (Limited Partnership) ("Zhuhai SB Xinchuang") to jointly invest in UCARsgen Biotech Limited ("UCARsgen"), to accelerate allogeneic CAR-T development in mainland China. Under the agreements, UCARsgen has secured the exclusive rights in mainland China for the research, development, manufacture, and commercialization of the following allogeneic CAR-T products from CARsgen Therapeutics: the BCMA-targeted allogeneic CAR-T cell therapy for the treatment of multiple myeloma and plasma cell leukemia and the CD19/CD20 dual-targeted allogeneic CAR-T cell therapy for the treatment of B-cell malignancies. An investment fund managed by Zhuhai SB Xinchuang (currently undergoing registration and filing procedures) subscribed to the newly increased registered capital of UCARsgen for a consideration of RMB 80,000,000, thus retaining an 8% equity stake in the registered capital of UCARsgen upon completion of the transaction, equity stake of CARsgen Therapeutics in UCARsgen will be diluted from 100% to 92%. Financial Highlights The revenue was around RMB39.4 million for the year ended December 31, 2024 mainly from zevor-cel, in which was calculated on the basis of ex-works price, rather than end-of-market prices. Our revenue is recognized upon completion of ex-works delivery of products. Besides, the Company received a milestone payment of RMB75 million from Huadong Medicine for zevor-cel for the year ended December 31, 2024. Due to the inherent time cycle of CAR-T manufacturing, there is a discrepancy between the number of orders obtained from Huadong Medicine and number of ex-works deliveries. The gross profit was around RMB14.8 million for the year ended December 31, 2024, with the selling and distribution expenses around RMB0.88 million. In the commercialization stage, we are demonstrating a strong cost competitive advantage, which is mainly due to self-manufacture for plasmids and vectors with stable output and high yield per batch. Cash and bank balances were around RMB1,479 million as of December 31, 2024. Cash and cash equivalents and deposits at the end of 2025 are expected to be not less than RMB1,080 million. We expect to have adequate cash into the 2028 excluding subsequent cash inflows. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, https://www.carsgen.com. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. Contact CARsgen For more information, please visit https://www.carsgen.com/
TOKYO, March 18, 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 million1) for the development of diagnostics for schistosomiasisSchistosomiasis 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: https://www.who.int/news-room/fact-sheets/detail/schistosomiasis 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.https://www.ghitfund.org/en Appendix 1. Project Details ID: G2024-202 Project Title In Support of WHO Schistosomiasis Control and Elimination Programs: Progressing a TPP-compliant serological test for Schistosoma mansoni to Field Testing and Manufacturing Process Development. Collaboration Partners 1. Drugs & Diagnostics for Tropical Diseases (DDTD) (USA) 2. MBL, Medical & Biological Laboratories Co., Ltd. (Japan) 3. Nagasaki University (Japan) 4. Kenya Medical Research Institute (Kenya) 5. Noguchi Memorial Institute for Medical Research (Ghana) 6. Big Eye Diagnostics, Inc. (USA) Disease Schistosomiasis Intervention Diagnostics Stage Product Development Awarded Amount JPY 472,729,041 (USD 3.2 million) Status Continued project Summary [Project objective] The overarching objective of this project is to deliver a fully TPP-compliant, easy-to-use, low-cost point-of-care test able to detect IgG1-type antibodies raised by the human host against selected S. mansoni antigens as an indicator for current or prior infection. The RDT delivered at the end of G2024-202 will have the required sensitivity and specificity to support Schistosomiasis monitoring, evaluation, and surveillance efforts in hypo-endemic areas post-MDA where stool-based or antigen-based diagnostics struggle to accurately determine disease prevalence. [Project design]The project team will pursue the following 6 specific objectives: -Objective 1: This first activity is aimed at defining the optimal use case(s) for our new serological test: Since serological testing is a new approach for schistosomiasis control and elimination programs, this work will be modelled in as much as appropriate on other NTDs that have already incorporated serological testing in their programmatic concepts (onchocerciasis, lymphatic filariasis, trachoma). -Objective 2: In the predecessor project, G2023-110, MBL produced the S. mansoni antigens and positive control antibodies in R&D grade quality. The production will now be moved to larger scale and ISO/QMS grade quality. -Objective 3: Given that the two prototype tests delivered at the end of G2023-110 (one for each S. mansoni antigen) already meet the TPP criteria, only limited further optimization work will be required, which may include generating and evaluating a biplex test as an alternative to the two singleplex tests. -Objective 4: Evaluate the laboratory diagnostic performance of the candidate RDT using extended patient sample panels and compare the results with egg count, PCR, CCA and/or CAA data as available, and determine the concordance with laboratory-based serological assays (ELISA/MBA). -Objective 5: Follow the clinical study plan established in Objective 1 to evaluate the diagnostic and operational performance of the candidate RDT in both endemic and non-endemic regions of Kenya and, potentially, Ghana. -Objective 6: A ISO13485-compliant automated large-scale manufacturing process will be developed by DDTD, modeled on those we have previously put in place for other tests. BEDx will then conduct an independent validation of the manufacturing process by producing 3 pilot lots of 10'000 units each, and quantifying the inter-lot consistency. Project Detail https://www.ghitfund.org/investment/portfoliodetail/detail/235/en ID: G2024-203 Project Title In Support of WHO Schistosomiasis Control and Elimination Programs: Development of a Sensitive and Specific Serological Rapid Diagnostic Test to Detect Infection by Schistosoma haematobium. Collaboration Partners 1. Drugs & Diagnostics for Tropical Diseases (DDTD) (USA) 2. MBL, Medical & Biological Laboratories Co., Ltd. (Japan) 3. Nagasaki University (Japan) 4. Kenya Medical Research Institute (Kenya) Disease Schistosomiasis Intervention Diagnostics Stage Technical Feasibility Awarded Amount JPY 314,446,720 (USD 2.1 million) Status New Summary [Project objective] The overarching objective of this project is to deliver a fully TPP-compliant, easy-to-use, low-cost point-of-care test able to detect antibodies raised by the human host against selected S. haematobium antigens as an indicator for current or prior infection. The RDT delivered at the end of G2024-203 will have the required sensitivity and specificity to support Schistosomiasis monitoring, evaluation, and surveillance efforts in hypo-endemic areas post-MDA where other diagnostic methods struggle to accurately determine disease prevalence. [Project design]The project team will pursue the following 4 specific objectives: -Objective 1: Define the most appropriate use case(s) for a serological S. haematobium test and present the proposed rationale and justification to the Schisto DTAG for endorsement. -Objective 2: Express the 5-10 most promising S. haematobium biomarkers from the literature and from previous work at CDC and NEKKEN, and evaluate their performance in an S. haematobium ELISA. -Objective 3: Generate RDT prototypes for each of the biomarker candidates down-selected in the preceding Objective, and evaluate the performance of the resulting singleplex LFAs in comparison with ELISA based on LOD, sensitivity, and specificity (non-specific binding). -Objective 4: Evaluate the diagnostic performance of the prototype RDT(s) delivered in the preceding Objective using extended patient sample panels, and compare the results with those from laboratory-based serological tests (ELISA/MBA) as well as with other, non-serological diagnostic methods (microscopy, PCR, CAA-test) wherever available. Project Detail https://www.ghitfund.org/investment/portfoliodetail/detail/236/en ID: G2023-201 Project Title Phase I clinical trial of novel dengue virus-like particle (VLP) vaccines Collaboration Partners 1. VLP Therapeutics, Inc. (USA) 2. Nagasaki University (Japan) Disease Dengue Intervention Vaccine Stage Clinical Phase I Awarded Amount JPY 885,198,600 (USD 5.9 million) Status Continued project Summary [Project objective] This Phase I clinical trial aims to evaluate the safety, immunogenicity, and efficacy of the tetravalent DENVLP vaccine. We will assess antibody titers, neutralizing antibody levels, and antibody-dependent enhancement (ADE) following vaccination. Additionally, we will evaluate the efficacy of infection protection using a challenge strain of the dengue virus. Objective 1: Manufacturing the DENVLP Vaccine | We will produce a high-quality, GMP-grade of the tetravalent DENVLP vaccine using our stable cell lines for dengue virus types 1-4. We will assess quality and stability. Objective 2: Phase I Clinical Study | We will conduct a placebo-controlled Phase I trial with four groups of healthy adults (ages 18-60) to test different vaccine doses. Participants will receive three doses. [Project design]Manufacturing and IND Submission: VLP Therapeutics (VLPT) will oversee the manufacturing and regulatory submission for the tetravalent DENVLP vaccine and design the clinical trial plan. Its group company, VLP Therapeutics Japan, will conduct GMP-compliant manufacturing of the tetravalent vaccine. After manufacturing, the vaccine will undergo quality testing before submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). Phase I Clinical Trial: A Phase I clinical trial will be conducted to evaluate the safety, immunogenicity, and efficacy of the DENVLP vaccine. The vaccine's safety and immunogenicity will be assessed, and a six-month follow-up will be conducted after vaccination. At six months, all participants will be exposed to a dengue virus challenge strain to evaluate vaccine efficacy. Project Detail https://www.ghitfund.org/investment/portfoliodetail/detail/237/en ID: S2024-112 Project Title AI-based screening for the identification of novel compounds against Chikungunya virus Collaboration Partners 1. Medicines for Malaria Venture (MMV) (Switzerland) 2. Eisai Co. Ltd. (Eisai) (Japan) Disease Chikungunya Intervention Drug Stage Screening Awarded Amount JPY 23,894,400 (USD 159,689.90) Status New Summary [Project objective] The project aims to use advanced computer-assisted screening to find new compounds that can prove effective in combatting Chikungunya virus. Initially, using state-of-the-art machine learning models, a large library of Eisai compounds will be screened in silico. Thereafter, hits from the in silico screen will be tested in vitro using established assays. This collaboration brings together the power of artificial intelligence, antiviral screening, and drug development expertise from a pharmaceutical company, Product Development Partner (PDP), and academic investigators in a country where Chikungunya virus is endemic. [Project design]The primary screening process will use an innovative two-step approach to maximize the available space for testing potential activity against Chikungunya virus. Around 50 primary hits will be chosen for further activity confirmation studies. Eisai will provide additional compounds for conducting these assays. For selected compounds, dose response curves (EC50) will be generated in the CHIKV assay, and their cytotoxicity profile (CC50) will be evaluated using the MTS assay. 5-10 confirmed active compounds will be prioritized for further profiling. To further assess their potential for broad spectrum activity within a virus family, these confirmed active compounds will be profiled against other alphaviruses. To assess specificity for the alphavirus genus, these confirmed actives will also be tested against SARS-CoV2 and mosquito-borne flaviviruses. Project Detail https://www.ghitfund.org/investment/portfoliodetail/detail/238/en ID: S2024-121 Project Title Screening project between DNDi and Shionogi & Co., Ltd. Collaboration Partners 1. Drugs for Neglected Diseases initiative (DNDi) (Switzerland) 2. Shionogi & Co., Ltd. (Japan) Disease Chagas disease Intervention Drug Stage Screening Awarded Amount JPY 23,200,938 (USD 155,055.38) Status New Summary [Project objective] The primary objective of this project is to identify novel T. cruzi active series from a unique proprietary compound collection made available by Shionogi & Co., Ltd. (Shionogi). [Project design]A chemically diverse library of approx. 42,000 compounds specifically designed for this project from Shionogi's chemical library will be screened against the intracellular amastigote stage of T. cruzi at Institute Pasteur Korea in a cell-based, high-throughput screening system. A sequential single concentration followed by full dose-response scheme will be applied. Hit series meeting GHIT/DNDi criteria for potential Chagas disease treatments will be prioritized for further development. Project Detail https://www.ghitfund.org/investment/portfoliodetail/detail/239/en *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: https://www.ghitfund.org/investment/overview/enPortfolio: https://www.ghitfund.org/investment/portfolio/enAdvancing Portfolio: https://www.ghitfund.org/investment/advancingportfolio/enClinical Candidates: https://www.ghitfund.org/investment/clinicalcandidates/en For more information, contact:Katy Lenard at +1-202-494-2584 or klenard@burness.comMina Ohata at +81-36441-2032 or mina.ohata@ghitfund.org
A12 藝術空間
Clinical Trials/Medical Discoveries
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