Telix FAP-targeting Therapeutic Published in Thyroid Journal: Demonstrates Encouraging Efficacy
Telix Pharmaceuticals (ASX/NASDAQ: TLX) has published promising results for its FAP-targeting therapy candidate TLX400 in the Thyroid journal. The study, involving 73 heavily pre-treated patients with radioiodine-resistant (RAI-R) thyroid cancer, demonstrated encouraging efficacy with median progression-free survival of 29 months and overall survival of 32 months.
The treatment showed a 50% partial response rate with manageable adverse events, primarily hematotoxicity. TLX400's novel structure enables prolonged tumor retention while minimizing off-target uptake, potentially offering advantages over current tyrosine kinase inhibitors (TKIs) like sorafenib and lenvatinib, which can have significant side effects.
Telix Pharmaceuticals (ASX/NASDAQ: TLX) ha pubblicato risultati promettenti per il suo candidato terapeutico TLX400 mirato al FAP, sul giornale Thyroid. Lo studio, condotto su 73 pazienti fortemente pretrattati con carcinoma tiroideo resistente al radioiodio (RAI-R), ha evidenziato un'efficacia incoraggiante con una sopravvivenza libera da progressione mediana di 29 mesi e una sopravvivenza globale di 32 mesi.
Il trattamento ha mostrato un tasso di risposta parziale del 50% con eventi avversi gestibili, principalmente ematotossicità. La struttura innovativa di TLX400 consente una prolungata ritenzione nel tumore minimizzando l'assorbimento fuori bersaglio, offrendo potenziali vantaggi rispetto agli attuali inibitori della tirosina chinasi (TKI) come sorafenib e lenvatinib, che possono causare effetti collaterali significativi.
Telix Pharmaceuticals (ASX/NASDAQ: TLX) ha publicado resultados prometedores para su candidato terapéutico TLX400 dirigido al FAP en la revista Thyroid. El estudio, que involucró a 73 pacientes con cáncer de tiroides resistente al radioyodo (RAI-R) y con múltiples tratamientos previos, mostró una eficacia alentadora con una supervivencia libre de progresión mediana de 29 meses y una supervivencia global de 32 meses.
El tratamiento presentó una tasa de respuesta parcial del 50% con eventos adversos manejables, principalmente hematotoxicidad. La estructura novedosa de TLX400 permite una retención prolongada en el tumor mientras minimiza la captación fuera del objetivo, lo que podría ofrecer ventajas frente a los inhibidores de tirosina quinasa (ITK) actuales como sorafenib y lenvatinib, que pueden causar efectos secundarios significativos.
Telix Pharmaceuticals (ASX/NASDAQ: TLX)는 FAP 표적 치료 후보인 TLX400의 유망한 결과를 Thyroid 저널에 발표했습니다. 방사성 요오드 저항성(RAI-R) 갑상선암을 앓고 있는 73명의 다중 치료 환자를 대상으로 한 연구에서 중앙 무진행 생존 기간 29개월과 전체 생존 기간 32개월이라는 고무적인 효능을 보였습니다.
치료는 50% 부분 반응률을 나타냈으며, 주로 혈액독성에 의한 관리 가능한 부작용이 있었습니다. TLX400의 혁신적 구조는 비표적 부위 흡수를 최소화하면서 종양 내 장기 체류를 가능하게 하여, 심각한 부작용이 있을 수 있는 현재 티로신 키나제 억제제(TKI)인 소라페닙과 렌바티닙보다 잠재적인 이점을 제공합니다.
Telix Pharmaceuticals (ASX/NASDAQ : TLX) a publié des résultats prometteurs pour son candidat thérapeutique ciblant le FAP, TLX400, dans la revue Thyroid. L'étude, menée auprès de 73 patients lourdement prétraités atteints d'un cancer de la thyroïde résistant à l'iode radioactif (RAI-R), a montré une efficacité encourageante avec une survie sans progression médiane de 29 mois et une survie globale de 32 mois.
Le traitement a présenté un taux de réponse partielle de 50% avec des effets indésirables gérables, principalement une hématotoxicité. La structure innovante de TLX400 permet une rétention prolongée dans la tumeur tout en minimisant la captation hors cible, offrant potentiellement des avantages par rapport aux inhibiteurs de tyrosine kinase (ITK) actuels comme le sorafénib et le lénvatinib, qui peuvent entraîner des effets secondaires importants.
Telix Pharmaceuticals (ASX/NASDAQ: TLX) hat vielversprechende Ergebnisse für seinen FAP-gerichteten Therapie-Kandidaten TLX400 im Fachjournal Thyroid veröffentlicht. Die Studie mit 73 stark vorbehandelten Patienten mit radiojodresistentem (RAI-R) Schilddrüsenkrebs zeigte eine ermutigende Wirksamkeit mit einer medianen progressionsfreien Überlebenszeit von 29 Monaten und einem Gesamtüberleben von 32 Monaten.
Die Behandlung zeigte eine partielle Ansprechrate von 50% bei gut handhabbaren Nebenwirkungen, hauptsächlich Hämatotoxizität. Die neuartige Struktur von TLX400 ermöglicht eine verlängerte Tumorretention bei gleichzeitiger Minimierung der Off-Target-Aufnahme, was potenzielle Vorteile gegenüber aktuellen Tyrosinkinase-Inhibitoren (TKIs) wie Sorafenib und Lenvatinib bietet, die erhebliche Nebenwirkungen haben können.
- None.
- Still in preliminary study phase
- Primary adverse event of hematotoxicity reported
- Limited to heavily pre-treated patients in current study
Insights
Telix's TLX400 shows promising survival data in resistant thyroid cancer with manageable safety profile, validating their FAP-targeting approach.
The publication in Thyroid journal represents significant external validation for Telix's FAP-targeting therapeutic candidate TLX400. Data from 73 heavily pre-treated patients with radioiodine-resistant (RAI-R) thyroid cancer demonstrated median progression-free survival of 29 months and overall survival of 32 months - metrics that the company indicates compare favorably to current standard tyrosine kinase inhibitors (TKIs).
Most noteworthy is the
The mechanism of action targeting Fibroblast Activation Protein (FAP) in cancer-associated fibroblasts addresses the tumor microenvironment that influences tumor growth and therapy resistance. TLX400's novel structure is designed for prolonged tumor retention while minimizing off-target effects, potentially overcoming limitations of first-generation FAP-targeting compounds.
While described as a "preliminary study," these results provide supporting evidence for Telix's radiopharmaceutical approach. The company is exploring broader applications across multiple solid tumors, including bladder cancer, suggesting expanded market potential beyond thyroid cancer for this theranostic platform.
MELBOURNE, Australia and INDIANAPOLIS, May 08, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that its Fibroblast Activation Protein (FAP)-targeting therapy candidate, TLX400, has been published in Thyroid, the official journal of the American Thyroid Association. The candidate demonstrated an encouraging safety profile and efficacy in aggressive, radioiodine-resistant (RAI-R) thyroid cancer1.
TLX400 (177Lu-DOTAGA.Glu.(FAPi)2) has been in-licensed by Telix as part of a portfolio of next-generation therapeutic and diagnostic (“theranostic”) radiopharmaceutical candidates2. TLX400 has potential clinical utility in several oncology indications. The publication provides further validation of the safety profile and potential efficacy of Telix’s lead FAP therapeutic candidate.
In this peer-reviewed manuscript, Dr. Sanjana Ballal and colleagues report results from 73 heavily pre-treated patients with RAI-R follicular thyroid carcinoma3. The authors conclude that TLX400 therapy demonstrated a promising safety profile and efficacy in aggressive, RAI-R thyroid cancer, achieving a median progression-free survival (PFS) and overall survival (OS) of 29 and 32 months, respectively, with a manageable adverse event profile.
The therapeutic approach to radioiodine-refractory thyroid cancer has advanced with tyrosine kinase inhibitors (TKIs) such as sorafenib and lenvatinib, supported by the DECISION trial4 and SELECT study5 results. However, their potential risks, including significant side effects, require careful management, particularly in patients with comorbidities such as cardiac issues, hypertension, stroke, and kidney dysfunction, who may not be optimal candidates for TKI therapy. Lutetium-177 (177Lu)-FAP inhibitor therapy marks a significant advancement in thyroid cancer theranostics, where FAP in cancer-associated fibroblasts (CAFs) influences the tumor microenvironment (TME), angiogenesis, and chemotherapy resistance. CAFs interact with cancer cells, fostering tumor growth and aggressiveness, highlighting their significance as therapeutic targets and in elucidating tumor progression mechanisms.
Dr. Sanjana Ballal, Senior Researcher at the All India Institute of Medical Sciences (AIIMS, New Delhi), investigator and lead author, commented, “This preliminary study highlights the promising safety profile and efficacy of TLX400 therapy in aggressive radioiodine-resistant thyroid cancer, including refractory cases. Notably, in the cohort of patients with reported efficacy, the treatment demonstrated median OS and PFS durations of 32 and 29 months, with a promising
TLX400 is differentiated by a novel structure that drives prolonged tumor retention while minimizing off-target uptake, designed to overcome the limitations seen with first-generation FAP-targeting compounds. These candidates have extensive pre-clinical and clinical data covering a range of tumors6. Telix is exploring the clinical utility of the FAP portfolio across a range of solid tumors, including bladder cancer.
Dr. David N. Cade, Group Chief Medical Officer, Telix, added, “We are highly encouraged by these data for TLX400, which compare favourably to TKIs – the standard of care treatment in patients with thyroid cancer – for OS and PFS. This provides further validation of the safety profile and efficacy potential enabled by the novel design of these FAP-targeting therapeutic candidates.”
The Thyroid publication is available online at: https://www.liebertpub.com/doi/10.1089/thy.2024.0229
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, Brazil, 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.
TLX400 has not received a marketing authorization in any jurisdiction.
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 Ballal et al. Thyroid. 2025. https://www.liebertpub.com/doi/10.1089/thy.2024.0229
2 Telix ASX disclosure 12 March 2025.
3 The data were collected as part of a compassionate use program covered by an overarching protocol, approved by the institutional ethics board.
4 Brose et al. Lancet. 2014.
5 Schlumberger et al. N Engl J Med. 2015.
6 See Telix investor presentation lodged with the ASX on 19 November 2024.
FAQ
What are the key results of TLX's TLX400 therapy for thyroid cancer?
How does TLX400 compare to current thyroid cancer treatments?
What are the main side effects of Telix's TLX400 therapy?
What makes TLX's TLX400 different from other FAP-targeting compounds?
What other cancers could Telix's TLX400 potentially treat?
