Telix to Showcase Urology Pipeline at Upcoming ASCO Genitourinary Cancers Symposium (ASCO GU 2025)
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) announces four presentations at ASCO GU 2025 in San Francisco, showcasing their therapeutic urologic pipeline. The presentations include preliminary data from the CUPID study of TLX592, demonstrating clinical proof-of-concept for their alpha therapy candidate for prostate cancer.
The company will present updates on ProstACT GLOBAL, their Phase 3 trial evaluating TLX591 in PSMA-positive mCRPC patients. Additionally, updates will be provided on the STARLITE-1 and STARLITE-2 trials, investigating TLX250 in combination with immunotherapy for kidney cancer treatment. TLX250 is positioned to be the first CAIX-targeting rADC to market and is advancing toward a pivotal trial in clear cell renal cell carcinoma.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) annuncia quattro presentazioni all'ASCO GU 2025 a San Francisco, che mettono in evidenza il loro programma terapeutico urologico. Le presentazioni includono dati preliminari dello studio CUPID di TLX592, che dimostra la prova di concetto clinica per il loro candidato alla terapia alfa per il cancro alla prostata.
L'azienda fornirà aggiornamenti su ProstACT GLOBAL, il loro studio di Fase 3 che valuta TLX591 in pazienti con mCRPC positivi al PSMA. Inoltre, verranno forniti aggiornamenti sugli studi STARLITE-1 e STARLITE-2, che indagano TLX250 in combinazione con l'immunoterapia per il trattamento del cancro ai reni. TLX250 è posizionato per essere il primo rADC mirato al CAIX sul mercato e sta avanzando verso uno studio cruciale nel carcinoma a cellule renali a cellule chiare.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) anuncia cuatro presentaciones en el ASCO GU 2025 en San Francisco, destacando su pipeline terapéutico urológico. Las presentaciones incluyen datos preliminares del estudio CUPID de TLX592, que demuestra la prueba de concepto clínica para su candidato de terapia alfa para el cáncer de próstata.
La empresa presentará actualizaciones sobre ProstACT GLOBAL, su ensayo de Fase 3 que evalúa TLX591 en pacientes con mCRPC positivos para PSMA. Además, se proporcionarán actualizaciones sobre los ensayos STARLITE-1 y STARLITE-2, que investigan TLX250 en combinación con inmunoterapia para el tratamiento del cáncer de riñón. TLX250 está posicionado para ser el primer rADC dirigido a CAIX en el mercado y avanza hacia un ensayo pivotal en carcinoma de células renales de células claras.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX)는 샌프란시스코에서 열리는 ASCO GU 2025에서 비뇨기학 치료 파이프라인을 소개하는 네 가지 발표를 발표했습니다. 발표에는 전립선암을 위한 알파 치료 후보인 TLX592의 CUPID 연구의 초기 데이터가 포함되어 있으며, 임상 개념 증명을 보여줍니다.
회사는 PSMA 양성 mCRPC 환자에서 TLX591을 평가하는 3상 시험인 ProstACT GLOBAL에 대한 업데이트를 제공합니다. 또한 신장암 치료를 위한 면역요법과 함께 TLX250을 조사하는 STARLITE-1 및 STARLITE-2 시험에 대한 업데이트도 제공됩니다. TLX250은 CAIX를 표적으로 하는 첫 번째 rADC로 시장에 출시될 예정이며, 명확한 세포 신장 세포 암종에 대한 주요 시험으로 나아가고 있습니다.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) annonce quatre présentations lors de l'ASCO GU 2025 à San Francisco, mettant en avant leur pipeline thérapeutique urologique. Les présentations incluent des données préliminaires de l'étude CUPID sur TLX592, démontrant une preuve de concept clinique pour leur candidat à la thérapie alpha pour le cancer de la prostate.
L'entreprise présentera des mises à jour sur ProstACT GLOBAL, leur essai de Phase 3 évaluant TLX591 chez des patients mCRPC positifs au PSMA. De plus, des mises à jour seront fournies sur les essais STARLITE-1 et STARLITE-2, qui étudient TLX250 en combinaison avec l'immunothérapie pour le traitement du cancer du rein. TLX250 est positionné pour être le premier rADC ciblant CAIX sur le marché et progresse vers un essai pivot dans le carcinome à cellules rénales claires.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) kündigt vier Präsentationen auf dem ASCO GU 2025 in San Francisco an, die ihre therapeutische urologische Pipeline präsentieren. Die Präsentationen umfassen vorläufige Daten aus der CUPID-Studie zu TLX592, die einen klinischen Nachweis des Konzepts für ihren Alpha-Therapiekandidaten bei Prostatakrebs zeigen.
Das Unternehmen wird Updates zu ProstACT GLOBAL präsentieren, ihrer Phase-3-Studie zur Bewertung von TLX591 bei PSMA-positiven mCRPC-Patienten. Darüber hinaus werden Aktualisierungen zu den Studien STARLITE-1 und STARLITE-2 bereitgestellt, die TLX250 in Kombination mit Immuntherapie zur Behandlung von Nierenkrebs untersuchen. TLX250 ist positioniert, um der erste CAIX-zielgerichtete rADC auf dem Markt zu sein, und schreitet auf eine entscheidende Studie bei klarzelligem Nierenzellkarzinom zu.
- Clinical proof-of-concept achieved for TLX592 alpha therapy candidate in prostate cancer
- Phase 3 trial ProstACT GLOBAL actively dosing patients in US and Asia Pacific
- TLX250 positioned to be first CAIX-targeting rADC to market
- None.
MELBOURNE, Australia and INDIANAPOLIS, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces presentations featuring the Company’s late-stage and next generation therapeutic programs at the upcoming American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU 2025) to be held in San Francisco, CA (US) from 13 – 15 February 2025.
Dr. David N. Cade, Telix Group Chief Medical Officer, said, “Telix will feature in four presentations at this year’s ASCO GU, which showcase the depth and differentiation of our therapeutic urologic pipeline, alongside our industry-leading precision medicine portfolio. For the first time at a medical congress, preliminary data will be presented from the CUPID study of TLX592, which was successful in demonstrating clinical proof-of-concept of Telix’s alpha therapy candidate for prostate cancer1.”
ProstACT GLOBAL, the first Phase 3 trial to evaluate Telix’s lead rADC2 therapy candidate, TLX591, in patients with PSMA3-positive mCRPC4 who have progressed while receiving a prior androgen receptor pathway inhibitor (ARPI) drug, is actively dosing patients in the United States and the Asia Pacific region and will be highlighted during a ‘Trials In Progress’ presentation.
In kidney cancer, Principal Investigators of the STARLITE-1 and -2 investigator-initiated trials will provide an update on design and status of these trials in progress. These groundbreaking studies are investigating Telix’s therapeutic candidate TLX250 in combination with immunotherapy in treatment-naïve and late-stage patients, respectively. TLX250 is positioned to be the first carbonic anhydrase IX (CAIX)- targeting rADC to market and is progressing toward a pivotal trial in clear cell renal cell carcinoma (ccRCC).
ASCO GU 2025 presentation details are listed below:
Title: A Phase 3 Study of 177Lu-rosoptamab Tetraxetan Plus Standard of Care vs. Standard of Care Alone in Patients with Metastatic Castration-Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT06520345
Date and Time: February 13, 2025 | 11:25 AM – 12:45 PM (PST)
Presenter: Oliver Sartor, MD, Mayo Clinic
Type: Trials in Progress Poster Session
Location: Level 1, West Hall | On Demand
Abstract: TPS303
Poster Bd: M22
Title: CUPID (64Cu-TLX592 Phase 1 PK, Biodistribution & Dosimetry): A Proof-of-Concept Study of TLX592 Targeted Alpha Therapy in Prostate Cancer
ClinicalTrials.gov ID: NCT04726033
Date and Time: February 13, 2025 | 11:25 AM – 12:45 PM (PST)
Presenter: David N. Cade, MD, Telix Pharmaceuticals
Type: Poster Session
Location: Level 1, West Hall | On Demand
Abstract: 177
Poster Bd: E16
Title: STARLITE-2: Phase 2 Study of Nivolumab plus 177Lutetium-labeled Anti–Carbonic Anhydrase IX (CAIX) Monoclonal Antibody Girentuximab (177Lu-girentuximab, TLX250) in Patients with Advanced ccRCC
ClinicalTrials.gov ID: NCT05239533
Date and Time: February 15, 2025 | 7:10 AM – 8:10 AM (PST)
Presenter: Darren Feldman, MD, Memorial Sloan Kettering Cancer Center
Type: Trials in Progress Poster Session
Location: Level 1, West Hall | On Demand
Abstract: TPS608
Poster Bd: K9
Title: STARLITE-1: Phase 1b/2 Study of Combination 177Lu Girentuximab (TLX250) Plus Cabozantinib and Nivolumab in Treatment Naive Patients with Advanced ccRCC
ClinicalTrials.gov ID: NCT05663710
Date and Time: February 15, 2025 | 7:10 AM – 8:10 AM (PST)
Presenter: Eric Jonasch, MD, The University of Texas, MD Anderson Cancer Center
Type: Trials in Progress Poster Session
Location: Level 1, West Hall | On Demand
Abstract: TPS614
Poster Bd: K15
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).
Telix’s lead prostate 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)5, by the Australian Therapeutic Goods Administration (TGA)6, by Health Canada7, by the Danish Medicines Agency8 and by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA)9. Illuccix is currently in national approval review in 18 European countries following a positive decentralized procedure (DCP) opinion by BfArM10.
Telix’s osteomyelitis (bone infection) imaging agent, technetium-99m (99mTc) besilesomab, marketed under the brand name Scintimun®, is approved in 32 European countries and Mexico. Telix’s miniaturized surgical gamma probe, SENSEI®, for minimally invasive and robotic-assisted surgery, is registered with the FDA for use in the U.S. and has attained a Conformité Européenne (CE) Mark for use in the European Economic Area. No other Telix product has received a marketing authorization in any jurisdiction.
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 Telix ASX disclosure 21 May 2024.
2 Radio antibody-drug conjugate.
3 Prostate-specific membrane antigen.
4 Metastatic castrate-resistant prostate cancer.
5 Telix ASX disclosure 20 December 2021.
6 Telix ASX disclosure 2 November 2021.
7 Telix ASX disclosure 14 October 2022.
8 Telix media release 11 February 2025.
9 Telix ASX disclosure 13 February 2025.
10 The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte). Telix ASX disclosure 17 January 2025.
FAQ
What are the key findings from Telix's CUPID study of TLX592 presented at ASCO GU 2025?
What is the current status of Telix's ProstACT GLOBAL Phase 3 trial for TLX591?
How is Telix's TLX250 being evaluated in kidney cancer treatment?
What makes TLX250 significant in Telix's pipeline?
