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Fratricide-resistant CD7 CAR-T therapy by NUS proves effective in treating relapsed or refractory T-cell leukaemia SINGAPORE, Oct. 5, 2024 /PRNewswire/ -- A new cell therapy, targeting CD7 on leukaemia cells, gives a potentially effective treatment for patients with T-cell acute lymphoblastic leukaemia (T-ALL) who have exhausted all standard treatment options. Published in the prestigious medical journal Nature Medicine on 3 September 2024[1], the study highlights the effectiveness of a new chimeric antigen receptor (CAR) T-cell therapy. Caption: A team of NUS Medicine and NUHS researchers and clinicians have developed a new fratricide-resistant CD7 CAR T-cell therapy that proves effective in treating relapsed or refractory T-cell leukaemia. Photo be credited to the National University Health System (NUHS). Developed in-house by researchers and clinicians from the Yong Loo Lin School of Medicine at the National University of Singapore (NUS Medicine) and the National University Health System (NUHS), the therapy was given to 17 patients between April 2019 and October 2023 at the National University Hospital (NUH) in Singapore and Ospedale Pediatrico Bambino Gesù in Rome, Italy. All the 17 patients, ranging from two to 72 years of age, had T-ALL that could not be eliminated with chemotherapy or had relapsed after treatment. Using a technology developed in Professor Dario Campana's laboratory under the Department of Paediatrics at NUS Medicine, the patient's own T cells were reprogrammed to express an anti-CD7 CAR, and then re-infused into the patients. The anti-CD7 CAR protein redirects the CAR T-cells to kill T-leukaemia cells that have CD7 protein on their surface. Notably, 16 of the 17 patients achieved complete remission within one month, and leukaemic cells became undetectable even with ultra-sensitive flow cytometry tests that can detect one leukaemia cell in the background of 10,000 normal cells, developed by Ms Elaine Coustan-Smith's laboratory at NUS Medicine. The same techniques were key to analyse CD7 expression in leukaemic cells and determining patient eligibility as well as to monitor expansion and persistence of CAR-T cells after infusion. The first patient treated with this therapy has been in remission for five years, without needing additional chemotherapy or a bone marrow transplant. The treatment was well-tolerated, and side effects were mild, given the fact that all patients enrolled had a high tumour burden and had received prolonged and intensive treatment prior to CAR-T therapy. T-ALL accounts for approximately 10 per cent of ALL cases in children and 25 to 30 per cent in adolescents and young adults[2],[3]. Although 70 to 80 per cent of children are cured with intensive and prolonged chemotherapy, the cure rate in adults remains approximately 60 per cent or lower[4]. Patients with relapsed or refractory T-ALL have less than 10 per cent survival, while in this series, 50 per cent survived. This fratricide-resistant CD7 CAR-T therapy is being trialled in NUH. Dr Bernice Oh, the first author of the study and a Consultant in the Division of Paediatric Haematology and Oncology at the Khoo Teck Puat – National University Children's Medical Institute (KTP-NUCMI), NUH, said: "This CAR-T therapy is a new and promising tool to treat T-ALL patients who have failed conventional treatment. These patients had exhausted all potentially curative options, and we are heartened that we could give them another clear chance at cure without severe side-effects. We are committed to seek better cures for patients with complex and treatment-resistant cancers." Professor Allen Yeoh, who led the clinical application of this new technology and is Head and Senior Consultant in the Division of Paediatric Haematology and Oncology at NUH's KTP-NUCMI and the National University Cancer Institute, Singapore, said: "While we celebrate this wonderful milestone, we are only at the beginning of this exciting journey. There is a lot of scientific and medical enquiry to understand how to better use CD7 CAR T-cells. Each patient, in this series, taught us a lot. Ultimately, for every member of our team, seeing each patient smile and given another chance, after achieving remission, is priceless." Professor Yeoh is also the VIVA-Goh Foundation Professor in Paediatric Oncology at NUS Medicine. This research is supported by the Singapore Ministry of Health through the National Medical Research Council (NMRC) Office, MOH Holdings Pte Ltd under the NMRC Singapore Translational Research Investigator Award (MOH-000708), NMRC Research Training Fellowship (MOH-000616), NMRC Clinician Scientist Award (NMRC/CSA/003/2008 and NMRC/CSA/0053/2013) and NMRC Centre Grant (NMRC/CG/NCIS/2010), as well as the Cancer Science Institute of Singapore, National University of Singapore, the Goh Foundation, Children's Cancer Foundation, Singapore Totalisator Board, Bone Marrow Donor Programme (Singapore) and VIVA Foundation for Children with Cancer. About the National University Health System (NUHS) The National University Health System (NUHS) aims to transform how illness is prevented and managed by discovering causes of disease, development of more effective treatments through collaborative multidisciplinary research and clinical trials, and creation of better technologies and care delivery systems in partnership with others who share the same values and vision. Institutions in the NUHS Group include the National University Hospital, Ng Teng Fong General Hospital, Jurong Community Hospital and Alexandra Hospital; three National Specialty Centres - National University Cancer Institute, Singapore (NCIS), National University Heart Centre, Singapore (NUHCS) and National University Centre for Oral Health, Singapore (NUCOHS); the National University Polyclinics (NUP); Jurong Medical Centre; and three NUS health sciences schools – NUS Yong Loo Lin School of Medicine (including the Alice Lee Centre for Nursing Studies), NUS Faculty of Dentistry and NUS Saw Swee Hock School of Public Health. With member institutions under a common governance structure, NUHS creates synergies for the advancement of health by integrating patient care, health science education and biomedical research. As a Regional Health System, NUHS works closely with health and social care partners across Singapore to develop and implement programmes that contribute to a healthy and engaged population in the Western part of Singapore. For more information, please visit www.nuhs.edu.sg. About the National University Hospital (NUH) The National University Hospital (NUH) is Singapore's leading university hospital. While the hospital at Kent Ridge first received its patients on 24 June 1985, our legacy started from 1905, the date of the founding of what is today the NUS Yong Loo Lin School of Medicine. NUH is the principal teaching hospital of the medical school. Our unique identity as a university hospital is a key attraction for healthcare professionals who aspire to do more than practise tertiary medical care. We offer an environment where research and teaching are an integral part of medicine, and continue to shape medicine and transform care for the community we care for. We are an academic medical centre with over 1,200 beds, serving more than one million patients a year with over 50 medical, surgical and dental specialties. NUH is the only public and not-for-profit hospital in Singapore to provide trusted care for adults, women and children under one roof, including the only paediatric kidney and liver transplant programme in the country. The NUH is a key member of the National University Health System (NUHS), one of three public healthcare clusters in Singapore. For more information, please visit: www.nuh.com.sg. About the National University Cancer Institute, Singapore The National University Cancer Institute, Singapore (NCIS) is an academic, national specialist centre for cancer under the National University Health System (NUHS), and is the only public cancer centre in Singapore that treats both paediatric and adult cancers in one facility. As one of two national cancer centres in Singapore, NCIS (pronounced as "n-sis") offers a broad spectrum of cancer care and management from screening, diagnosis and treatment to rehabilitation and survivorship, as well as palliative and long-term care. NCIS' strength lies in the multi-disciplinary approach taken by our clinician scientists and clinician-investigators to develop a comprehensive and personalised plan for each cancer patient NCIS provides the full suite of specialised oncology and haematology services at the NUH Medical Centre at Kent Ridge, Singapore, including those by the NCIS Chemotherapy Centre, NCIS Radiotherapy Centre and NCIS Cellular Therapy Centre. NCIS also offers cancer services at other hospitals in Singapore: NCIS Cancer & Blood Clinic @ Ng Teng Fong General Hospital NCIS Radiotherapy Centre @ Tan Tock Seng Hospital NCIS Radiotherapy Clinic @ Khoo Teck Puat Hospital To bring cancer care even closer to our patients, our NCIS on the Go programme delivers a range of cancer services at clinics within the community for their convenience. For more information, please visit www.ncis.com.sg. About the Yong Loo Lin School of Medicine, National University of Singapore (NUS Medicine) The NUS Yong Loo Lin School of Medicine is Singapore's first and largest medical school. Our enduring mission centres on nurturing highly competent, values-driven and inspired healthcare professionals to transform the practice of medicine and improve health around the world. Through a dynamic and future-oriented five-year curriculum that is inter-disciplinary and inter-professional in nature, our students undergo a holistic learning experience that exposes them to multiple facets of healthcare and prepares them to become visionary leaders and compassionate doctors and nurses of tomorrow. Since the School's founding in 1905, more than 12,000 graduates have passed through our doors. In our pursuit of health for all, our strategic research programmes focus on innovative, cutting-edge biomedical research with collaborators around the world to deliver high impact solutions to benefit human lives. The School is the oldest institution of higher learning in the National University of Singapore and a founding institutional member of the National University Health System. It is one of the leading medical schools in Asia and ranks among the best in the world (Times Higher Education World University Rankings 2024 by subject and the Quacquarelli Symonds (QS) World University Rankings by subject 2023). For more information about NUS Medicine, please visit https://medicine.nus.edu.sg/ About the National Medical Research Council (NMRC) The NMRC was established in 1994 to oversee research funding from the Ministry of Health and support the development and advancement of biomedical research in Singapore, particularly in the public healthcare clusters and medical schools. NMRC engages in research strategy and planning, provides funding to support competitive research grants and core research enablers, and is responsible for the development of clinician scientists through awards and fellowships. The council's work is supported by the NMRC Office which is part of MOH Holdings Pte Ltd. Through its management of the various funding initiatives, NMRC promotes healthcare research in Singapore, for better health and economic outcomes. [1] Oh, B.L.Z., Shimasaki, N., Coustan-Smith, E. et al. Fratricide-resistant CD7-CAR T cells in T-ALL. Nat Med (2024). https://doi.org/10.1038/s41591-024-03228-8 [2] Teachey, D. T. & Pui, C.-H. Comparative features and outcomes between paediatric T-cell and B-cell acute lymphoblastic leukaemia. Lancet Oncol. 20, e142–e154 (2019). [3] Raetz, E. A. et al. Outcome for children and young adults with T-cell ALL and induction failure in contemporary trials. J. Clin. Oncol. 41, 5025–5034 (2023). [4] Abaza, Y. et al. Hyper-CVAD plus nelarabine in newly diagnosed adult T-cell acute lymphoblastic leukemia and T-lymphoblastic lymphoma. Am. J. Hematol. 93, 91–99 (2018).
TU2218 is a potentially first-in-class dual inhibitor targeting transforming growth factor beta receptor 1 (TGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2) The first patient with head and neck squamous cell carcinoma was dosed in the Phase 2a clinical trial of TU2218 The Phase 2a trial of TU2218 starts with head and neck squamous cell carcinoma, as well as biliary tract cancer patients. It will be later expanded to colorectal cancer patients BOSTON and SEONGNAM, South Korea, Oct. 4, 2024 /PRNewswire/ -- TiumBio Co., Ltd. (Kosdaq: 321550), a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapeutics for patients with rare and incurable diseases, announced today that the first patient has been dosed in its Phase 2 clinical trial of TU2218. TU2218 is a novel oral dual inhibitor targeting TGFR1 and VEGFR2. TGF-ß and VEGF pathways are known to suppress the activity of immune checkpoint inhibitors (ICIs), so TU2218 is expected to improve the efficacy of ICIs by blocking the two pathways. In Phase 1a and 1b clinical trials, TiumBio evaluated the safety, pharmacokinetics, and pharmacodynamics of TU2218 as a monotherapy and in combination with Keytruda (pembrolizumab) in 41 patients with advanced solid tumors. These profiles were used to determine the dose levels for Phase 2 trials. The Phase 2a trial is designed to assess the safety and efficacy of TU2218 in combination with Keytruda in patients with head and neck squamous cell carcinoma (HNSCC), biliary tract cancer (BTC), and colorectal cancer (CRC). The Phase 2 trial begins at Seoul National University Hospital and Asan Medical Center in South Korea, which is planned to expand to hospitals in the United States. The first dose was administered to an HNSCC patient. HNSCC refers to malignant tumors that occur in the oral cavity, throat, larynx, or salivary glands. The standard treatment typically involves surgery and radiation therapy. According to Global Data, as of 2023, the number of HNSCC patients worldwide is estimated to be around 610,000, and it is expected to exceed 670,000 by 2030. "HNSCC is a disease with a high unmet medical need, as the average survival rate for first-line treatments is known to be only about one year," said Hun-taek Kim, Ph.D., MBA, CEO of TiumBio. "We have selected cancer types for the Phase 2 clinical trial based on other trials that demonstrated strong anti-cancer effects from targeting TGF- ß or VEGF pathways. Our goal is to develop TU2218 as a first-line treatment for HNSCC," he added. In the Phase 1b trial, among 10 patients with advanced solid tumors who received a 195mg daily dose (the determined dose for Phase 2) of TU2218 with Keytruda, three patients achieved partial response (PR) and five patients had stable disease (SD), yielding an 80% disease control rate (DCR). About TiumBio Co., Ltd. TiumBio (Kosdaq: 321550) is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapeutics for patients with rare and incurable diseases. Its mission is to expand the hope and happiness of mankind through our science. TiumBio boasts three leading pipeline assets: merigolix (code name: TU2670), TU2218, and TU7710, all in various stages of clinical development. Merigolix is a once-daily, oral GnRH receptor antagonist being developed for the treatment of endometriosis and uterine fibroids and is undergoing in global Phase 2 clinical trials. TU2218 is a first-in-class oral immune-oncology therapy targeting TGF-β and VEGF pathways to promote response rates in cancer patients when used in combination with immune checkpoint inhibitors. TU7710 is a novel rFVIIa designed to extend its half-life in order to provide more clinical benefits to hemophilia patients with inhibitors. With its expertise in drug development, TiumBio is committed to the discovery and development of innovative treatments to ease the burden of debilitating diseases. For further information, visit our website at www.tiumbio.com/en and connect with us on LinkedIn. Contacts:Junseok Jang, Head of Corporate Communications & Investor Relationsjunseokjang@tiumbio.comSuna Cho, Manager, Corporate Communications & Investor Relationssunacho@tiumbio.comDa-ye Song, Manager, Corporate Communications & Investor Relationsdayesong@tiumbio.com
Customers are being notified of the importance of checking built-in alerts and alarms for battery status and to contact Medtronic for pump replacement if affected by this issue GALWAY, Ireland, Oct. 4, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 series insulin pumps to follow their pump's built-in alerts and alarms for battery status and to contact Medtronic if they observe changes in the battery life of their pump. Medtronic began investigating this issue upon receiving customer reports of shortened battery life and a comprehensive analysis found that pumps that have been dropped, bumped, or experienced physical impact even once may result in shortened battery life due to damage to internal electrical components. This electrical issue also causes battery alerts to occur when less battery life remains than the User Guide states. This may result in the pump stopping insulin delivery significantly sooner than usually expected and could lead to health risks like hyperglycemia or diabetic ketoacidosis (DKA), potentially requiring medical intervention. Most recently, Medtronic has received 170 reports of hyperglycemia >400mg/dL and 11 reports of diabetic ketoacidosis from January 2023 to September 2024 in the US potentially related to this issue. The FDA has classified this action as a class I recall. Medtronic issued an updated notification to customers stating the following: Even a single drop of the pump could result in reduced battery life, either immediately after the drop, or over time, and the issue will continue even after replacing the battery. The pump will still generate battery alerts and alarms, but these alerts and alarms may not be delivered with the usual amount of battery life remaining before the battery must be replaced to avoid the pump stopping insulin delivery. Be prepared to replace the battery as soon as the "Low Battery Pump" alarm sounds. Users should always carry an extra set of new AA lithium or alkaline batteries or fully charged NiMH batteries should they need to replace the battery sooner than expected. Users who notice a significant decrease in battery life from their usual experience, regardless of whether their pump has been dropped, bumped, or has experienced physical impact, should contact their local Medtronic team to determine whether a replacement pump is needed. Customers in the U.S. can call 1-800-378-2292 for 24-hour technical support. Customer outside the U.S. can click on this link to find the number for their local support team. Users are advised to have a back-up therapy available in case it's needed. ''Medtronic began proactively notifying impacted pump users in July because of the high priority we place on patient safety and understand the important role of pumps in the care and management of diabetes," said Robert Vigersky, MD, Chief Medical Officer, Medtronic Diabetes. "Our team is here 24 hours a day, 7 days a week to help if you experience battery depletion or any other issue with your pump. Patient safety is our priority, as is continuity of therapy, which is why we made the decision to voluntarily notify patients and will replace pumps when needed." The original notification and the updated notification are available on the Medtronic Diabetes website. About the Diabetes Business at Medtronic (www.medtronicdiabetes.com) Medtronic is working together with the global community to change the way people manage diabetes. The company aims to transform diabetes care by expanding access, integrating care and improving outcomes, so people living with diabetes can enjoy greater freedom and better health. About Medtronic Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Contacts: Janet Cho Ryan Weispfenning Public Relations Investor Relations +1 (818) 403-7028 +1 (763) 505-4626 MiniMedTM 670G insulin pump MiniMedTM 780G insulin pump
Top industry leaders to explore AI, data, strategic partnerships, and innovation opportunities in Latin America at premier Life Sciences event LONDON, Oct. 4, 2024 /PRNewswire/ -- Clarivate Plc (NYSE: CLVT) a leading global provider of transformative intelligence, today announced the full agenda for the 2nd annual Summit LATAM, which will be held in Milan on October 7, 2024, ahead of the CPHI Milan conference. In partnership with the Brazilian Association of the Pharmaceutical Ingredients Industry (Abiquifi), this year's event reinforces the industry's commitment to patient welfare by showcasing how collective efforts and innovative strategies are reshaping the pharmaceutical ecosystem, with a focus on navigating market challenges and uncovering innovation opportunities. In the wake of the pandemic, the global pharmaceutical industry faced a slowdown in growth, prompting companies to swiftly identify new opportunities and areas of innovation. As the Latin American market is valued at $98 billion,1 with projected growth of 10.1%—outpacing North America (3.1%) and Europe (3.9%)—navigating this region is crucial for the future of the global pharmaceutical landscape. To maintain a competitive edge and ensure return on investment, organizations must adopt effective, cross-functional solutions. Summit LATAM 2024 will offer attendees the chance to explore obstacles, discover new opportunities, and discuss strategies for accelerating development processes in the region. Henry Levy, President, Life Sciences and Healthcare, Clarivate, said: "At Clarivate, we have been committed to driving innovation and delivering strategic solutions in Latin America for over two decades. Our mission is to foster collaboration across the life sciences and healthcare sectors, empowering organizations to navigate the evolving pharmaceutical landscape. We are proud to unite industry leaders through Clarivate Summit LATAM, in partnership with ABIQUIFI, to address the region's most pressing challenges and unlock new opportunities for growth and innovation." Norberto Prestes, President, Abiquifi, said: "There can be no serious and efficient planning if we don't have quality data. Abiquifi has innovation as a priority part of its strategy and to this end we are expanding our partnership with Clarivate so that we can carry out a quality LATAM mobilization in order to expand the production and development of innovative IFAS in the bloc. The meetings we hold in each country are guided by the data provided by Clarivate. The high-quality information brings the LATAM reality to the center of discussions and helps us define priorities, understand where there are opportunities to act in the medium term and what we should invest in long-term research in the region." Cristian Madoery, Director Sales Latam, Life Sciences and Healthcare, Clarivate, said: "Summit LATAM Milan offers a valuable opportunity to connect with key leaders in the Latin American pharmaceutical sector. Clarivate has been actively fostering an ecosystem in Latin America, bringing together diverse players to strengthen the region's immense professional and technological potential. Platforms like this are enriching for all involved, providing a unique chance to share ideas, exchange knowledge, and learn from one another." This year's agenda features insights and perspectives from industry leaders and analysts, with sessions focused on innovative partnerships, artificial intelligence, regulatory guidelines and API production. Noteworthy sessions include: From information to innovation: Driving growth in Latin America with data and artificial intelligence, presentation by Cristian Madoery, Director Sales Latam, Life Sciences & Healthcare, Clarivate and Leticia Terra, Solutions Consultant, Life Sciences and Healthcare, Clarivate Interactions and partnerships in Latin America: Strategy or survival? Identifying and executing competitive partnership, panel discussion by Stephani Saverio, VP Business Development, Knight Therapeutics, Juliana Megid, Institutional Relations Director, EMS, Federico Rivera, Business Development, Gene Pharm and Anna Paula Guembes, New Business Director, Libbs Farmacêutica Implementation of regulatory guidelines attractive to the market and aimed at optimizing access to the population, by Marcus Aurelio Miranda de Araujo, General Manager of GGFIS, ANVISA Local API production: What's missing in Latin America? With strategies based on the search for sustainable raw materials, panel discussion by Norberto Prestes, Executive President, Abiquifi, Marcelo Mansur, CEO, Nortec and Javier Mestre, General Manager, Emcure Mexico and José Ézio Nogueira, CEO, Globe Química Notes to editors Summit LATAM takes place on Monday, October 7, 2024, at the Hotel NH Collection, Milan. Register to attend and learn more on this premier event, here or here. Meet the Clarivate Latam team at Pharma Connection, hosted by Abiquifi on October 7, 2024 at Hotel NH Collection, Milan at 9:00 AM. Learn more, here. Following the summit, join the Clarivate team of life sciences and healthcare experts at CPHI Milan 2024 from Oct 8-10 at booth 14F84 or at the Brazilian Delegation. Learn how to transform complex markets, API, and regulatory data into actionable insights. Meet with the Clarivate team, here. Connect with Clarivate Life Sciences and Healthcare. Join the conversation and mention Clarivate and Summit LATAM on X and LinkedIn. #SummitLATAM #PatientCare #Pharma #Clarivate #ThinkForward About Abiquifi Founded in 1983, the Brazilian Association of the Pharmaceutical Ingredients Industry (Abiquifi) is a non-profit organization that brings together the main companies in the pharma-chemical sector in Brazil. Our mission is to promote the development and production of pharmaceutical ingredients in the country, meeting the demands of the domestic industry and strengthening Brazil's presence on the international market. With the support of our members, government agencies and other institutions representing the sector, Abiquifi leads strategic initiatives to increase the competitiveness and visibility of the national industry. About ClarivateClarivate™ is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. For more information, please visit www.clarivate.com Media Contact:Luna IvkovicExternal Communications, Life Sciences & Healthcarenewsroom@clarivate.com 1 Source: PharmaBoardroom. (2022). Infigures: Latin America 2022. https://pharmaboardroom.com/country-reports/infigures-latin-america-2022/
HONG KONG, GERMANTOWN, Md., and SUZHOU, China,, Oct. 4, 2024 /PRNewswire/ -- Sirnaomics Ltd. (the "Company", together with its subsidiaries, the "Group" or "Sirnaomics"; stock code: 2257.HK), a leading biopharmaceutical company engaged in the discovery and development of advanced RNAi therapeutics, announced that the Company has entered into a subscription agreement with Dr. Poon Hung Fai ("Dr. Poon"), the subscriber. Dr. Poon intends to subscribe for 17,527,696 subscription shares at a subscription price of approximately HK$3.36 per share, representing approximately 16.7% of the issued share capital of the Company as enlarged by the allotment and issue of the subscription shares. The gross proceeds of the subscription will be approximately HK$58.9 million. Dr. Poon's extensive experience and successful background in the biotechnology sector will help drive the Group's business development and drug R&D process, further enhancing the Group's core competitiveness. In addition, Dr. Poon's keen market insight will facilitate the Group's strategic planning and resource allocation, and help the Group achieve long-term growth and sustainable development. Dr. Patrick Lu, Founder, Chairman of the Board and CEO of Sirnaomics, said: "We are very pleased to sign the subscription agreement with Dr. Poon, which will not only provide significant financial support to Sirnaomics, but also further optimize our shareholding structure. With Dr. Poon's extensive experience and successful track record in the biopharma industry, coupled with Sirnaomics' pioneering and solid business foundation in nucleic acid drug innovation, we believe that this strong partnership will provide the Group with great opportunities to advance its lead products and broaden its business development horizon, as well as strengthen the Group's financial health." About Sirnaomics Sirnaomics is an RNA therapeutics biopharmaceutical company that focuses on the discovery and development of innovative drugs for indications with unmet medical needs and large market opportunities. Sirnaomics is the first clinical-stage RNA therapeutics company to have a strong presence in both Asia and the United States. Based on its proprietary delivery technologies, a polypeptide nanoparticle RNAi platform and GalNAc RNAi platform, GalAhead™, Sirnaomics has established an enriched drug candidate pipeline. STP122G, which represents the first drug candidate utilizing the Company's GalAhead™ technology, is currently in Phase I development. The Company has also had multiple successes with oncology applications through its clinical programs for STP705 and STP707. With the establishment of the Group's manufacturing facility in China, Sirnaomics is undergoing a transition from a biotech company to a biopharma corporation. Learn more at: www.sirnaomics.com.
- MSD will supply KEYTRUDA to be evaluated in combination with ABL Bio's ABL103 in a Phase 1b/2 clinical trial SEONGNAM, South Korea, Oct. 4, 2024 /PRNewswire/ -- ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that it has entered into a clinical trial collaboration and supply agreement with MSD (a subsidiary of Merck & Co., Inc., Rahway, NJ, USA), to evaluate ABL103 in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced or metastatic solid tumors. Under the terms of the agreement, ABL Bio will conduct a phase 1b/2 clinical trial to evaluate the safety and efficacy of ABL103 in combination with KEYTRUDA. In this combination study, MSD will supply KEYTRUDA. ABL103 is bispecific antibody that simultaneously targets B7-H4 and 4-1BB. ABL103 is one of the pipeline programs in which ABL Bio's 4-1BB based bispecific antibody platform 'Grabody-T' has been applied. Grabody-T is designed to activate T cells only in the tumor microenvironment, reducing the liver toxicity of conventional 4-1BB monoclonal antibody and enhancing the antitumor activity. ABL103 also has mechanism to activate the 4-1BB signaling pathways in the tumor microenvironments where the B7-H4 antigens exist, allowing T cells to selectively attack tumor cells while sparing normal cells. Currently, the dose escalation part of the phase 1 clinical trial for ABL103 is ongoing in South Korea. Sang Hoon Lee, CEO of ABL Bio said "we are pleased to enter into this clinical collaboration agreement with MSD. With this agreement, we are ready to move on to the next stage of ABL103 clinical development. We hope that the combination of ABL103 and KEYTRUDA contributes to a better life for patients with advanced or metastatic solid tumors. To date, the phase 1 study for ABL103 monotherapy is progressing smoothly, and we will do our best in clinical development to achieve meaningful results from ABL103." Meanwhile, ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform 'Grabody'. More than 15 clinical projects for more than 7 assets, including ABL001, ABL111, ABL503, ABL105, ABL202, ABL301, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In the case of ABL001, the U.S. Food and Drug Administration (FDA) recently granted Fast Track designation to support the rapid development of this new drug candidate. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs). KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
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