Telix Announces First Patient Dosed in First-in-Human ZOLAR Trial of TLX300-CDx in Advanced Soft Tissue Sarcoma
Telix Pharmaceuticals (ASX/NASDAQ: TLX) has announced the dosing of the first patient in its Phase 1 ZOLAR trial of TLX300-CDx at the Melbourne Theranostic Innovation Centre. The trial evaluates 89Zr-olaratumab in patients with advanced, metastatic soft tissue sarcoma (STS).
The first-in-human study aims to assess safety, pharmacokinetics, biodistribution, and optimal dosing of TLX300-CDx. The diagnostic agent targets PDGFRα, a protein commonly overexpressed in STS. The trial's findings will guide the selection of therapeutic radionuclides for future treatment applications.
Telix holds exclusive worldwide rights to develop radiolabelled forms of olaratumab, originally developed by Eli Lilly. The company plans to develop a targeted radionuclide therapy for STS patients, addressing the current challenges in treating metastatic disease that typically responds poorly to chemotherapy.
Telix Pharmaceuticals (ASX/NASDAQ: TLX) ha annunciato la somministrazione del primo paziente nel suo trial di Fase 1 ZOLAR per TLX300-CDx presso il Melbourne Theranostic Innovation Centre. Lo studio valuta 89Zr-olaratumab in pazienti con sarcoma dei tessuti molli avanzato e metastatico (STS).
Lo studio, il primo sull'uomo, mira a valutare la sicurezza, la farmacocinetica, la biodistribuzione e il dosaggio ottimale di TLX300-CDx. L'agente diagnostico mira a PDGFRα, una proteina comunemente sovraespressa nello STS. I risultati del trial guideranno la selezione dei radionuclidi terapeutici per future applicazioni di trattamento.
Telix detiene i diritti esclusivi a livello mondiale per sviluppare forme radiomarcate di olaratumab, originariamente sviluppato da Eli Lilly. L'azienda prevede di sviluppare una terapia con radionuclidi mirati per i pazienti con STS, affrontando le attuali sfide nel trattamento della malattia metastatica che tipicamente risponde male alla chemioterapia.
Telix Pharmaceuticals (ASX/NASDAQ: TLX) ha anunciado la dosificación del primer paciente en su ensayo de Fase 1 ZOLAR de TLX300-CDx en el Melbourne Theranostic Innovation Centre. El ensayo evalúa 89Zr-olaratumab en pacientes con sarcoma de tejidos blandos avanzado y metastásico (STS).
El estudio de primera en humanos tiene como objetivo evaluar la seguridad, la farmacocinética, la biodistribución y la dosificación óptima de TLX300-CDx. El agente diagnóstico se dirige a PDGFRα, una proteína que se sobreexpresa comúnmente en el STS. Los hallazgos del ensayo guiarán la selección de radionúclidos terapéuticos para futuras aplicaciones de tratamiento.
Telix tiene derechos exclusivos a nivel mundial para desarrollar formas radiomarcadas de olaratumab, desarrollado originalmente por Eli Lilly. La empresa planea desarrollar una terapia con radionúclidos dirigidos para pacientes con STS, abordando los desafíos actuales en el tratamiento de enfermedades metastásicas que típicamente responden mal a la quimioterapia.
텔릭스 제약 (ASX/NASDAQ: TLX)는 멜버른 테라노스틱 혁신 센터에서 TLX300-CDx의 1상 ZOLAR 시험에서 첫 번째 환자의 투여를 발표했습니다. 이 시험은 진행성 전이성 연조직 육종(STS) 환자에서 89Zr-올라라투맙을 평가합니다.
인체 대상 첫 연구는 TLX300-CDx의 안전성, 약물 동태학, 생체 분포 및 최적 용량을 평가하는 것을 목표로 합니다. 진단 제제는 STS에서 일반적으로 과발현되는 단백질인 PDGFRα를 표적으로 합니다. 시험 결과는 향후 치료 응용을 위한 방사성 동위원소의 선택을 안내할 것입니다.
텔릭스는 엘리 릴리(Eli Lilly)가 원래 개발한 올라라투맙의 방사성 표지 형태를 개발할 수 있는 전 세계 독점 권리를 보유하고 있습니다. 이 회사는 STS 환자를 위한 표적 방사성 동위원소 치료법을 개발할 계획이며, 일반적으로 화학요법에 잘 반응하지 않는 전이성 질환 치료의 현재 문제를 해결하고자 합니다.
Telix Pharmaceuticals (ASX/NASDAQ: TLX) a annoncé l'administration de la première dose à un patient dans son essai de Phase 1 ZOLAR pour TLX300-CDx au Melbourne Theranostic Innovation Centre. L'essai évalue 89Zr-olaratumab chez des patients atteints de sarcome des tissus mous avancé et métastatique (STS).
Cette étude de première sur l'homme vise à évaluer la sécurité, la pharmacocinétique, la biodistribution et le dosage optimal de TLX300-CDx. L'agent diagnostique cible PDGFRα, une protéine souvent surexprimée dans le STS. Les résultats de l'essai guideront la sélection de radionucléides thérapeutiques pour de futures applications thérapeutiques.
Telix détient des droits exclusifs dans le monde entier pour développer des formes radiomarquées d'olaratumab, initialement développé par Eli Lilly. L'entreprise prévoit de développer une thérapie par radionucléides ciblés pour les patients atteints de STS, afin de relever les défis actuels dans le traitement des maladies métastatiques qui répondent généralement mal à la chimiothérapie.
Telix Pharmaceuticals (ASX/NASDAQ: TLX) hat die Dosisverabreichung des ersten Patienten in seiner Phase-1-Studie ZOLAR zu TLX300-CDx im Melbourne Theranostic Innovation Centre bekannt gegeben. Die Studie bewertet 89Zr-olaratumab bei Patienten mit fortgeschrittenem, metastasierendem Weichgewebesarkom (STS).
Die erste Studie am Menschen zielt darauf ab, die Sicherheit, Pharmakokinetik, Biodistribution und optimale Dosierung von TLX300-CDx zu bewerten. Der diagnostische Wirkstoff zielt auf PDGFRα, ein Protein, das im STS häufig überexprimiert ist. Die Ergebnisse der Studie werden die Auswahl therapeutischer Radionuklide für zukünftige Behandlungsanwendungen leiten.
Telix hält weltweit exklusive Rechte zur Entwicklung von radiomarkierten Formen von olaratumab, das ursprünglich von Eli Lilly entwickelt wurde. Das Unternehmen plant, eine gezielte Radionuklidtherapie für STS-Patienten zu entwickeln, um die aktuellen Herausforderungen bei der Behandlung von metastasierenden Erkrankungen anzugehen, die typischerweise schlecht auf Chemotherapie ansprechen.
- First patient dosed in Phase 1 ZOLAR trial, advancing clinical development pipeline
- Exclusive worldwide rights to develop radiolabelled olaratumab
- Addresses unmet medical need in metastatic soft tissue sarcoma treatment
- TLX300-CDx has not received marketing authorization in any jurisdiction
- Early-stage Phase 1 trial with uncertain outcomes
Insights
This first-in-human trial for TLX300-CDx represents a scientifically intriguing approach to a challenging cancer. Soft tissue sarcomas (STS) are notoriously difficult to treat once metastatic, with effective systemic options and poor response to conventional chemotherapy.
The theranostic approach here is particularly noteworthy. By using zirconium-89 labeled olaratumab as a diagnostic PET agent first, Telix can accomplish several critical objectives: 1) confirm target expression (PDGFRα) in individual patients, 2) understand biodistribution patterns to predict both efficacy and potential toxicity, and 3) calculate precise dosimetry to optimize subsequent therapeutic dosing.
PDGFRα represents a rational target for STS, as it's frequently overexpressed across various sarcoma subtypes. While olaratumab as a standalone antibody (without radioactivity) previously failed to improve overall survival in a Phase 3 trial, the addition of targeted radiation could fundamentally change its therapeutic potential by delivering cytotoxic radiation directly to tumor cells.
This Phase 1 study will collect essential safety and imaging data that will inform therapeutic radionuclide selection - likely choosing between beta emitters (like lutetium-177) or alpha emitters (like actinium-225) depending on tumor penetration needs and normal tissue tolerance.
Though early-stage, this trial demonstrates Telix's commitment to expanding their radiopharmaceutical platform beyond prostate and kidney cancers into rare oncology indications with significant unmet needs.
This clinical milestone represents positive pipeline advancement for Telix, though investors should recognize it's still very early-stage development. The initiation of first-in-human studies for TLX300-CDx adds another potential growth avenue beyond Telix's more advanced programs.
Strategically, this program demonstrates three important aspects of Telix's business approach: 1) leveraging their radiopharmaceutical expertise across multiple cancer types, 2) employing a theranostic model that could improve patient selection and treatment outcomes, and 3) repurposing previously developed antibodies through licensing deals (in this case from Eli Lilly).
The exclusive worldwide rights to radiolabeled olaratumab represents a valuable asset, particularly as this approach could potentially revitalize a targeting molecule that showed promise but ultimately disappointed as a standalone therapy.
For context within Telix's portfolio, this program sits behind more advanced assets like Illuccix (approved), TLX250-CDx (Phase 3), and TLX591 (Phase 3). However, it addresses a different market in soft tissue sarcoma - a rare cancer with approximately 13,000 new cases annually in the US alone and effective treatments for metastatic disease.
While financial impact remains years away, successful early-stage data could trigger increased investor attention to Telix's broader radiopharmaceutical platform strategy. The expansion into sarcoma diversifies Telix's oncology footprint beyond their existing focus areas of prostate, kidney, and brain cancers.
MELBOURNE, Australia, April 02, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX; NASDAQ: TLX, Telix, the Company) today announces that a first patient has been dosed in the Phase 1 ZOLAR1 trial of TLX300-CDx (89Zr-olaratumab) in patients with advanced, metastatic soft tissue sarcoma (STS) at the Melbourne Theranostic Innovation Centre (MTIC) in Melbourne, Australia.
ZOLAR is a first-in-human, proof-of-concept and biodistribution trial that uses positron emission tomography (PET) to evaluate olaratumab, a monoclonal antibody, as a therapeutic radiopharmaceutical targeting platform. Olaratumab targets platelet-derived growth factor receptor alpha (PDGFRα) a cell surface protein often over-expressed in STS.
The aim of the trial is to evaluate the safety, pharmacokinetics, biodistribution and dosimetry, and establish the optimal dose of TLX300-CDx in patients with advanced STS, prior to therapeutic studies, based on a theranostic approach. As part of the study, it is also expected that the patient dosimetry and target expression characteristics will inform the final selection of therapeutic radionuclide for this candidate, in conjunction with currently active non-clinical radiation biology studies.
Telix intends to develop a novel targeted radionuclide therapy, specific for PDGFRα, which could be used to treat patients with STS. Telix holds the exclusive worldwide rights to develop and commercialize radiolabelled forms of olaratumab, which was originally developed by Eli Lilly and Company (Lilly).
Professor Rodney Hicks AM, Founder, Chair, and Chief Medical Officer at MTIC, and Principal ZOLAR Investigator, said, “Sarcomas are individually very rare and they can arise from a variety of different tissues. Unfortunately, they tend to respond rather poorly to chemotherapy. While localized STS generally responds to radiotherapy, it is challenging to treat once it has spread. Targeted radionuclide therapy, which targets cancer cells throughout the body, is therefore an attractive option to treat disseminated disease. At MTIC, we're fortunate to be the first site validating this investigational agent as a precision diagnostic and to inform the design of future therapeutic studies.”
Dr. David N. Cade, Telix Group Chief Medical Officer, added, “We are pleased that a first patient has been imaged in the first-in-human ZOLAR trial, which is designed to inform both the potential efficacy (dosimetry) and safety profile of this research candidate as a therapeutic, based on a theranostic approach. We would like to thank Professor Hicks and his team at MTIC for their commitment to addressing unmet medical need in STS, as well as the patients who will contribute to this important trial.”
Visit the Telix website to view a short video of Professor Hicks explaining the theranostic approach in soft tissue sarcoma here.
TLX300-CDx has not received a marketing authorization in any jurisdiction.
About Soft Tissue Sarcoma (STS)
Soft tissue sarcoma is a complex disease that encompasses a diverse group of relatively rare cancers, with more than 50 malignant histological subtypes. In the United States (U.S.), it is estimated that there will be approximately 13,520 new diagnoses and 5,420 deaths from STS in 2025, representing
About olaratumab
Olaratumab (previously marketed under the brand name, Lartruvo®) was originally developed by Lilly as a monoclonal antibody targeting PDGFRα. Olaratumab was granted "Accelerated Approval" in the U.S. and "Conditional Approval" in the EU based on Phase 2 trial data. Olaratumab was voluntarily withdrawn from the market by Lilly following the failure of the Phase 3 ANNOUNCE clinical trial, in which olaratumab in combination with standard chemotherapy did not improve survival for patients compared to chemotherapy alone.
In April 2022, Telix secured the exclusive worldwide rights to develop and commercialize radiolabelled forms of olaratumab for the diagnosis and treatment of human cancers4. Olaratumab has a well-established clinical safety profile and a favorable toxicology dataset, which Telix is leveraging for radiopharmaceutical development.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Canada, 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. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).
Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
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1 ClinicalTrials.gov ID: NCT06537596.
2 American Cancer Society 2025.
3 In et al. Ther Adv Med Oncol. 2017.
4 Telix ASX disclosure 11 April 2022.
FAQ
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