News & Views | Telix Pharmaceuticals Limited

First Patient Dosed in Phase II ‘CA-NINE’ Trial of TLX250-CDx for Detection of Recurrent Kidney Cancer After Surgery

Telix 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.

‘Highly Accurate’: Telix’s Phase III ZIRCON Trial for Kidney Cancer Imaging Published in The Lancet Oncology

Telix today announces that primary results from its Phase III ZIRCON trial have been published in The Lancet Oncology, reporting that Telix’s first-in-class investigational PET agent, TLX250-CDx (Zircaix®, 89Zr-girentuximab), is highly accurate in detecting and characterising clear cell renal cell carcinoma (ccRCC) in patients with indeterminate renal masses (IRMs).

Telix Completes TLX250-CDx (Zircaix®) BLA Submission for Kidney Cancer Imaging

Telix today announces that it has completed the submission of a Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for its investigational radiodiagnostic PET agent, TLX250-CDx (Zircaix®, 89Zr-DFO-girentuximab), for the characterisation of renal masses as clear cell renal cell carcinoma (ccRCC).

Telix Announces Positive rPFS Data from ProstACT SELECT Trial of TLX591 rADC Therapy Candidate in Prostate Cancer

Telix today announces additional positive data from the ProstACT SELECT trial (“SELECT”) of TLX591 (177Lu rosopatamab tetraxetan), a lutetium-labelled rADC therapy for the treatment of adult patients with PSMA-positive metastatic castrate-resistant prostate cancer (mCRPC). SELECT is a radiogenomics study intended to evaluate lesion concordance between 68Ga (gallium)-based PSMA-PET[4] imaging and TLX591 dosimetry for the purpose of validating PET imaging for patient selection for rADC therapy. The Company has previously reported final safety data from this study[3].

World First Use of Lightpoint’s SENSEI® Drop-In Gamma Probe in Bladder Cancer Surgery Performed in Spain

Lightpoint Surgical Limited (Lightpoint), an affiliate of Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces a world-first bladder cancer sentinel lymph node (SLN) procedure with SENSEI®, Telix's miniature robotic-assisted gamma probe used to detect radiation in patients and guide surgery. The patient was operated on at Hospital del Mar in Barcelona, Spain.

First Patient Dosed in Italian Named Patient (Early Access) Program for TLX250-CDx, Telix’s Kidney Cancer Imaging Agent

Telix today announces that the first patient has been dosed in its named patient program in Italy for TLX250-CDx (89Zr-DFO-girentuximab, Zircaix®). TLX250-CDx is the Company’s investigational non-invasive carbonic anhydrase IX (CAIX) targeting positron emission tomography (PET) imaging agent for clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer.

QDOSE® Platform Partnership for Personalised Dosimetry in Radiopharmaceutical Therapy

QDOSE® Platform Partnership for Personalized Dosimetry in Radiopharmaceutical Therapy

Telix Highlights Presentations at Upcoming ASCO Genitourinary Cancers Symposium (ASCO GU 2024)

Telix today announces presentations featuring the Company’s theranostic programs at the upcoming American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU 2024) to be held in San Francisco, CA (US) from 25 – 27 January 2024.

Telix Submits Biologics License Application (BLA) for TLX250-CDx (Zircaix™) for Imaging of Kidney Cancer

Telix today announces that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for its investigational positron emission tomography (PET) imaging agent TLX250-CDx (Zircaix™, 89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC).

First Patient Dosed in U.S. Expanded Access Program for TLX250-CDx, Telix’s Breakthrough Kidney Cancer Imaging Agent

Telix today announces that the first patient has been dosed in a United States (U.S.) expanded access program (EAP, ClinicalTrials.gov ID: NCT06090331) for TLX250-CDx (89Zr-DFO-girentuximab). TLX250-CDx is the Company’s first-in-class, non-invasive investigational positron emission tomography (PET) imaging agent in clear cell renal cell carcinoma (ccRCC).