News & Views

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).

Telix today announces that the first patient has been dosed in a global Phase II study of the Company’s carbonic anhydrase- (CAIX)-targeting PET/CT[1] imaging agent TLX250-CDx (89Zr-DFO-girentuximab), exploring this potential target across a broad range of cancer indications.

Telix today announces that it has entered into an agreement with Bayer AG (Bayer) to supply Illuccix® (TLX591-CDx, kit for the preparation of gallium Ga 68 gozetotide injection)[1] for the Phase III ARASTEP study (ClinicalTrials.gov Identifier: NCT05794906). This global study is investigating the efficacy of Bayer’s androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence who have no evidence of metastatic disease by conventional imaging and a positive PSMA-PET/CT[2] at baseline.

Telix today announces successful preclinical development of radiolabelled olaratumab, an antibody licensed from Eli Lilly and Company (Lilly). Telix has demonstrated proof-of-concept (PoC) of using olaratumab to selectively deliver both diagnostic and therapeutic radiation to tumours as a radiopharmaceutical moiety and has produced a candidate for clinical translation. Telix will now progress to first-in-human clinical studies based on these highly encouraging results.

Telix today announces the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved a Phase I study of TLX101 investigational therapy (4-L-[131I] iodo-phenylalanine, or 131I-IPA) in Chinese patients with newly diagnosed glioblastoma (GBM).

Telix today announces detailed positive results from its completed pivotal Phase III ZIRCON trial (ClinicalTrials.gov Identifier: NCT03849118)1. The study met primary and secondary endpoints, with TLX250-CDx demonstrating the ability to reliably characterise and detect the clear cell phenotype and provide a non-invasive method of diagnosing the presence and spread of ccRCC, delivering on an unmet medical need in this disease setting.

Telix today announces the successful completion of its joint research project conducted with Heidelberg University Hospital (UKHD) under the Research Cooperation Agreement announced in February 2021.1 The aim of this project was to create and validate a generator-based theranostic compound for urologic oncology targeting PSMA2 and utilising the beta-emitting isotope rhenium-188 (188Re).

Telix today announces that the completed pivotal Phase III ZIRCON study (ClinicalTrials.gov Identifier: NCT03849118) of TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC) has been selected for oral presentation at the upcoming 2023 ASCO GU Symposium to be held in San Francisco, CA, from February 16-18 2023.   ASCO GU, the leading specialised event for GU cancer care worldwide, will be the forum at which the Company will present the complete results of the ZIRCON trial in detail, including all trial primary and secondary end-points as well as specific grading criteria related to lesion size and detection.

Telix today announces that a first patient has been dosed in a Phase II investigator-initiated study of TLX101 in combination with external beam radiation therapy (EBRT) in patients with recurrent high-grade gliomas (HGG), including glioblastoma multiforme (GBM).

Telix today announces preliminary data from two separate investigator-initiated studies of TLX250-CDx (89Zr-DFO-girentuximab) in triple negative breast cancer (TNBC) and non-muscle-invasive bladder cancer (NMIBC), part of a comprehensive series of studies evaluating CAIX expression in cancers other than clear cell renal cell carcinoma (ccRCC), supporting Telix’s goal to rapidly expand the CAIX program into other indications beyond kidney cancer.