Aus Qu3- Bericht Telix vom 20.10.
Finale Daten zu Phase III in der ersten November-Woche!
Renal cancer / CAIX program
The Company expects to report top line data from the ZIRCON Phase III study of TLX250-CDx (89Zr-DFO-girentuximab), an investigational product for the imaging of clear cell renal cell carcinoma (ccRCC) with positron emission tomography (PET) around the first week of November 2022.
The Company is preparing to launch an Expanded Access Program (EAP) to enable eligible patients to access TLX250- CDx to address unmet need and requests for access under the healthcare professional responsibility prior to marketing authorisation. This is in accordance with Telix’s Compassionate Use Policy subject to jurisdictional regulatory requirements1 in selected countries, dependent on local regulatory requirements.
Subsequent to quarter (17 October 2022), Telix announced a collaborative development and reseller agreement with GE Healthcare to supply two of its PET imaging radiotracers (TLX250-CDx and [18F]-FLac (18F-3-fluoro-2-hydroxypropionate)) for use in third party pharmaceutical company clinical research and development activities.2 The agreement will see
these two investigational agents added to GE Healthcare’s immuno-diagnostic portfolio. GE Healthcare’s Pharmaceutical Diagnostics business is an established global supplier of PET imaging tracers to the global clinical research market. This partnership will enable these investigational imaging agents to be used more widely in third-party clinical trials, separate to Telix’s commercialisation of TLX250-CDx.
The Company also reported that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) approved a pivotal Phase III registration study that will bridge to Telix’s global Phase III ZIRCON trial.3 The bridging study is required to provide "supplementary" data obtained in a Chinese population to establish that the diagnostic efficacy of this investigational product is equivalent in Chinese and Western populations. A dosimetry study enrolling 10 patients will precede the multi-centre Phase III bridging study, which is expected to enrol 100 patients. The investigational new drug (IND) application was submitted by Telix’s partner in the Greater China region, Grand Pharma.
TLX250-CDx potential for indication expansion
Positive preliminary data from two separate investigator-initiated studies in triple negative breast cancer (TNBC) (OPALESCENCE study) and non-muscle-invasive bladder cancer (NMIBC) (PERTINENCE study), were presented at the European Association of Nuclear Medicine (EANM) Annual Congress held in Barcelona, Spain from 15-19 October 2022.4 These studies evaluating carbonic anhydrase IX (CAIX) expression in cancers other than ccRCC, support Telix’s goal to rapidly expand the CAIX program into other indications beyond kidney cancer.
OPALESCENCE (NCT04758780) a Phase II study of TLX250-CDx is investigating how carbonic anhydrase IX (CAIX) targeting imaging with PET can be utilised for the diagnosis and staging of TNBC and its potential as a therapeutic
target in this patient population. Preliminary data demonstrates the feasibility of girentuximab to target CAIX expression
in TNBC. Early results suggest potential for girentuximab as an imaging agent and therapeutic in this poor prognosis disease: 83% patient lesions had a CAIX strong expression allowing TLX250-CDX immunoPET detection, showing promise for further investigation.
Based on these results, TLX250-CDx is an attractive novel investigative targeting agent for TNBC and potential alternative to biopsy and immunohistochemistry (IHC) for staging metastatic disease and targeted radioligand therapy. Should
the targeting properties of this PET/CT imaging tracer be established in TNBC, Telix’s intention is to broaden future applications for lutetium-177 and actinium-225 based CAIX therapies.
PERTINENCE (NCT04897763), an open-label, proof of concept study to evaluate safety profile, biodistribution and tumour targeting properties of TLX250-CDx given directly into the bladder in patients with NMIBC and to establish CAIX as a potential therapeutic target in this condition. Preliminary data from this feasibility, dosimetry and imaging study at Institut de Cancérologie de l’Ouest (ICO), shows encouraging tumour targeting and biodistribution with TLX250-CDx, and no systemic distribution of radiation. Based on these results, Telix’s partner ATONCO intends to progress TLX250 labelled with the alpha-emitter astatine-211 (211At) into a first-in-human Phase I targeted alpha therapy (TAT) study.
1. Telix Compassionate Use Policy, accessible at: telixpharma.com/wp-content/uploads/Policy-on-Offerin…