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PLANTATION, Florida and HOUSTON, Texas, Oct. 8, 2024 /PRNewswire/ -- GBI Biomanufacturing, a leading Contract Development and Manufacturing Organization (CDMO), and Allterum Therapeutics, a Fannin-Founded Company, are pleased to announce a manufacturing partnership to advance Allterum's lead candidate 4A10 into clinic. 4A10 is a monoclonal antibody (mAb) targeting CD127, a receptor expressed by a broad variety of cancers. With this collaboration, GBI will leverage their extensive expertise in manufacturing complex biologics to ensure the high-quality production of 4A10 for Phase 1/2a clinical trials. Allterum's initial trial will focus on patients who have acute lymphoblastic leukemia (ALL), with subsequent expansion to trials in patients with other CD127-expressing hematological malignancies, including lymphomas and acute myeloid leukemia. "We are honored to be chosen by Allterum as their trusted partner on this important project," said Karl Pinto, Chairman and CEO of GBI. "Our team is dedicated to providing the highest quality development and manufacturing services for drug substance and drug product, ensuring the success of this promising treatment. This collaboration is a testament of our commitment to advancing the field of oncology and making a meaningful difference in the lives of patients." Atul Varadhachary, Allterum's CEO and Managing Partner at Fannin added, "4A10 has demonstrated robust preclinical activity across multiple cancers and we are excited about advancing it into clinic. We selected GBI as our manufacturing partner based on their years of experience with complex biologics, and we look forward to working together to ensure our program's success." Allterum's 4A10 development program is supported by grant funding from the Cancer Prevention and Research Institute of Texas (CPRIT), the National Cancer Institute (NCI) and additionally has been supported through the NCI Experimental Therapeutics Program (NExT). The antibody, invented at the NCI by senior investigator Scott Durum, PhD and his collaborators, is licensed exclusively to Allterum. Allterum has received Orphan Drug and Rare Pediatric Disease designations for ALL from the FDA, which will provide facilitated access to the FDA and potentially qualify 4A10 for a Pediatric Priority Review Voucher. Successful completion of Allterum's Phase 1/2a clinical trials will mark a significant milestone in developing this promising anti-cancer drug, addressing major unmet medical needs. To learn more about GBI, click the link below: https://www.gbibio.com/ To learn more about Allterum Therapeutics, click the link below: https://allterum.com/ To learn more about Fannin Partners, click the link below: https://www.fannininnovation.com/ Media Contact: info@GbiBio.com Logo - https://mma.prnasia.com/media2/2523494/GBI_Biomanufacturing.jpg?p=medium600Logo - https://mma.prnasia.com/media2/2523058/ALLTERUM_01.jpg?p=medium600
TEL AVIV, Israel, Oct. 7, 2024 /PRNewswire/ -- Medinol Ltd. is pleased to announce the successful First-in-Human (FIH) implantation of the ChampioNIR Drug-Eluting Peripheral Stent by Drs Gerard S.Goh and Thodur Vasudevan of the Alfred Hospital in Melbourne Australia, introducing a revolutionary advancement in the mechanics, durability and drug delivery of peripheral drug eluting stents. The ChampioNIR Drug-Eluting Peripheral Stent System poses a transformational technology designed to improve patient outcomes and procedural success. In a first of its kind hybrid mechanical design, radial support is provided by the metallic component of the stent, whereas longitudinal structure is provided by a bioresorbable polymeric mesh providing unsurpassed flexibility and long-term durability in even the most challenging anatomies. Furthermore, a unique drug-elution paradigm releases drug from the entire cylindrical area of the stent, drastically reducing diffusion distances and allowing, for the first time, therapeutic dosing of a large peripheral vessel with a 'limus' drug for an extended period of time. "We were impressed with ChampioNIR's deliverability and its straightforward deployment", said Prof. Gerard S Goh, Head of Interventional Radiology at The Alfred Hospital. "The Frictionless Deployment Mechanism made the precise positioning of the stent very straightforward". Dr. Yoram Richter, CEO of Medinol, added: "Medinol is excited to bring to clinical practice the culmination of years of research and development into novel stent designs, tailor-made for unmet clinical challenges in vascular interventions". The CHAMPIONSHIP First In Human study will enroll a total of 30 patients across 7 sites in Australia and the United States. Prof. Sahil Parikh, PI of the CHAMPIONSHIP study commented "The ChampioNIR stent represents a breakthrough in treatment for SFA lesions. I am excited to see this device come to life after years of development." About Medinol Founded in 1992, Medinol is a privately held company with offices in the U.S. and Israel, employing over 300 people. Extending more than 30 years of experience in the stent market, Medinol is aggressively changing paradigms in how disease states are diagnosed and treated. By designing cutting edge scaffolds for stenting multiple areas of the human body, dramatically reducing complications in Structural Heart procedures and providing real time insights into physiological metrics through Implantable Microsensors, Medinol looks years into the future to create pioneering medical devices. For more information, see www.medinol.com. Contact: Jeff Roach jeffr@medinol.com Logo - https://mma.prnasia.com/media2/1894777/Medinol_Logo.jpg?p=medium600
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
- 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.
MELBOURNE, Australia, Oct. 4, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the first patient has been dosed in a Phase II trial exploring the clinical utility of Telix's first-in-class investigational PET[1] agent, TLX250-CDx (89Zr-girentuximab) in recurrent clear cell renal cell carcinoma (ccRCC) after surgery. 'CA-NINE'[2] – led by Professor Brian Shuch at University of California, Los Angeles (UCLA) – is a Phase II prospective, single-centre trial comparing the diagnostic performance of TLX250-CDx PET/CT[3] to conventional imaging (contrast-enhanced CT alone) in 91 patients with intermediate-to-high risk ccRCC post-surgery. The investigator-initiated trial is designed to identify ccRCC where it has recurred, including metastatic disease, and is one of multiple trials either underway or planned, which may inform future label expansion for TLX250-CDx. Professor Brian Shuch, MD, Director of the Kidney Cancer Program and the Alvin & Carrie Meinhardt Endowed Chair in Kidney Cancer Research at UCLA Institute of Urologic Oncology, and Principal Investigator on the CA-NINE trial, said, "Telix's ZIRCON trial demonstrated the accuracy of TLX250-CDx at diagnosing localised ccRCC. However, we know that many patients die of metastatic disease, where the cancer has spread. There are plenty of data showing that metastatic ccRCC also expresses the carbonic anhydrase IX (CAIX) biomarker, which demonstrates potential use beyond localised ccRCC. We are on the cusp of a revolution in how we detect and manage advanced kidney cancer before and after surgery, and I'm excited to work with Telix to hopefully bring this technology to patients should it receive regulatory approval." Associate Professor Jeremie Calais, MD, Director of the Theranostics Program of the Ahmanson Translational Theranostics Division of the Department of Molecular and Medical Pharmacology at UCLA School of Medicine, and an investigator on the CA-NINE trial, added, "With TLX250-CDx it is exciting that we can now characterise indeterminate renal masses with greater confidence. However, this only scratches the surface of the clinical potential of this investigational agent. With conventional imaging, we are very limited in our ability to stage patients, and we are hopeful that this investigational agent will improve patient outcomes by shedding light on sites of recurrent ccRCC outside of the kidney." Dr David N. Cade, Chief Medical Officer at Telix continued, "We are pleased that a first patient has been imaged in the CA-NINE trial, which supports potential label expansion for TLX250-CDx into recurrent, metastatic disease. We would like to thank Professor Shuch and Associate Professor Calais at UCLA for their commitment to addressing unmet medical need in kidney cancer, as well as the patients who will contribute to this important trial." About TLX250-CDx TLX250-CDx (Zircaix®[4] 89Zr-girentuximab) is an investigational PET agent that is under development to characterise indeterminate renal masses as ccRCC or non-ccRCC in a non-invasive manner. Telix's pivotal Phase III ZIRCON trial (ClinicalTrials.gov ID: NCT03849118) evaluating TLX250-CDx in 300 patients, of which 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% positive-predictive value for ccRCC across three independent readers[5]. We believe this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing ccRCC. Confidence intervals exceeded expectations in all three readers, showing evidence of high accuracy and consistency of interpretation. As part of Telix's commitment to access to medicine, the Company continues to run an expanded access program (EAP) in the U.S.[6], named patient programs (NPPs) in Europe, and a special access scheme (SAS) in Australia to allow continued access to TLX250-CDx outside of a clinical trial to patients for whom there are no comparable or satisfactory alternate options. Telix's Policy on Offering Compassionate Use to Investigational Medicines can be downloaded at the following link. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). Telix's lead imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)[7], by the Australian Therapeutic Goods Administration (TGA) [8], and by Health Canada[9]. No other Telix product has received a marketing authorisation in any jurisdiction. Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn. Telix Investor Relations Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com Legal Notices You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX) or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "believe", "outlook", "forecast" and "guidance", or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix's product candidates, manufacturing activities and product marketing activities; Telix's sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix's product candidates, if or when they have been approved; Telix's ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. ©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals® and Illuccix® and Zircaix®[4] names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. [1] Positron emission tomography. [2] ClinicalTrials.gov ID: NCT06447103. [3] Computed tomography. [4] Brand name subject to final regulatory approval. [5] Shuch et al. Lancet Oncology. 2024. [6] ClinicalTrials.gov ID: NCT06090331. [7] Telix ASX disclosure 20 December 2021. [8] Telix ASX disclosure 2 November 2021. [9] Telix ASX disclosure 14 October 2022.
Clinical Trials/Medical Discoveries
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