News & Views | Telix Pharmaceuticals Limited

Positive Topline Results from Phase II OPALESCENCE Study of TLX250-CDx in Triple Negative Breast Cancer Presented at SABCS

Telix announces positive topline results from the Phase II OPALESCENCE investigator-initiated trial (IIT) of its carbonic anhydrase IX (CAIX)-targeting positron emission tomography (PET) imaging candidate, TLX250-CDx (89Zr-DFO-girentuximab), in patients with triple negative breast cancer (TNBC). Results will be presented today at the 2023 San Antonio Breast Cancer Symposium® (SABCS).

First Patient Dosed in European 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 a named patient (early access) program in the Netherlands for its investigational positron emission tomography (PET) imaging agent TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer.

Phase II OPALESCENCE Study of TLX250-CDx in Triple Negative Breast Cancer to be Presented at SABCS

Telix today advises that the completed Phase II OPALESCENCE investigator-initiated trial (IIT) of its carbonic anhydrase IX (CAIX)-targeting positron emission tomography (PET) imaging candidate, TLX250-CDx (89Zr-DFO-girentuximab), in patients with triple-negative breast cancer (TNBC), will be presented at the 2023 San Antonio Breast Cancer Symposium® (SABCS) taking place from December 5-9, 2023.

First Patient Dosed in Phase III ProstACT GLOBAL Study of Antibody-based Prostate Cancer Therapy Candidate, TLX591

Telix today announces that the first patient has been dosed in the Company’s Phase III ProstACT GLOBAL study of its investigational prostate-specific membrane antigen (PSMA) targeting radio-antibody drug conjugate (rADC) therapy, TLX591 (177Lu-rosopatamab tetraxetan). TLX591 is a rADC composed of a high-specificity PSMA-targeting antibody, chelator linker, and cytotoxic lutetium (177Lu) payload. The PSMA-targeted monoclonal antibody (mAb) approach offers significantly different targeting and pharmacology to anti-PSMA small molecules.

ProstACT SELECT Study of TLX591 Interim Readout: Positive Results Confirm Safety and Tolerability

Telix today announces positive preliminary results from the Phase I ProstACT SELECT study of its rADC therapy candidate TLX591 (Lutetium (177Lu) rosopatamab tetraxetan) for prostate-specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer (mCRPC).

Telix to Showcase New ZIRCON Phase III Kidney Cancer Imaging Data and Theranostic Pipeline at EANM

Telix today announces presentations featuring the Company’s theranostic programs at the 36th Annual Congress of the European Association of Nuclear Medicine (EANM) to be held in Vienna from 9 – 13 September 2023.

First Patient Dosed in Pivotal Phase III Study of TLX591-CDx (Illuccix®) for Prostate Cancer Imaging in Chinese Patients

Telix today announces that a first patient has been dosed in China in the pivotal Phase III registration study of TLX591-CDx (Illuccix®, Kit for the preparation of 68Ga-PSMA-11), for the imaging of prostate cancer using positron emission tomography (PET).

First Patient Dosed in IPAX-2 Study of TLX101 Brain Cancer Therapy Candidate in Patients with Newly Diagnosed Glioblastoma

Telix today announces that a first patient has been dosed in a Phase I study of the Company’s investigational therapy TLX101 (4-L-[131I] iodo-phenylalanine, or 131I-IPA) in combination with post-surgical standard of care treatment in patients with newly diagnosed glioblastoma, the most common and aggressive form of primary brain cancer.

First Patient Dosed in STARSTRUCK Study

Telix today announces that the first patient has been dosed in a Phase I study of the Company’s investigational targeted radiation therapy, TLX250, in combination with a Merck KGaA, Darmstadt, Germany (Merck) DNA-dependent protein kinase (DNA-PK) inhibitor candidate, peposertib (M3814). The study is being conducted in patients with solid tumours expressing carbonic-anhydrase IX (CAIX), a potential pan-cancer target.

New ZIRCON Phase III Data Presented at SNMMI: Potential Utility of TLX250-CDx in Staging and Monitoring ccRCC

today announces further details of the positive results from its completed pivotal Phase III ZIRCON study of TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) (ClinicalTrials.gov Identifier: NCT03849118).