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 (
64
Cu-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
177
Lutetium-labeled Anti–Carbonic Anhydrase IX (CAIX) Monoclonal Antibody Girentuximab (
177
Lu-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
177
Lu 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: [email protected]
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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.
