Two New Studies to Explore Telix Assets in Breast Cancer Theranostics

Melbourne (Australia) – 18 August 2021. Telix announces two new studies to evaluate the potential utility of TLX591-CDx and TLX250-CDx in breast cancer.

Telix today announces the initiation of two new investigator-led studies to evaluate the potential utility of the Company’s late-stage imaging portfolio in women’s health, initially in two sub-types of breast cancer with a significant unmet medical need. Both TLX591-CDx and TLX250-CDx have potential utility in breast cancer imaging, particularly for specific phenotypes that are not consistently well imaged using existing techniques.

A first patient has been dosed in a Proof-of-Concept study using TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11 injection) for the detection of occult metastases of lobular breast cancer (also called invasive lobular carcinoma, or ILC). The study is led by Dr. David Schuster at Winship Cancer Institute of Emory University and will recruit 20 patients over two years.

TLX591-CDx targets glutamate carboxypeptidase II (GCPII), also more generally known as prostate specific membrane antigen (PSMA), a protein that is highly expressed in many cancers, including ILC. While Telix has filed for regulatory approval of TLX591-CDx in prostate cancer imaging (investigational product illuccix® kit), this study marks the first formal clinical investigation of TLX591-CDx in another indication of interest. ILC is the second most common form of breast cancer, affecting about 10 percent of people with invasive breast cancer. Currently, there are no accurate imaging techniques for staging lobular breast cancer, adversely impacting clinicians’ ability to inform decisions about optimal treatment and management of the disease.

Principal Investigator of the study, Dr. David Schuster said, “Ga-PSMA imaging is being used increasingly for prostate cancer assessment, but it also has potential to be utilized in areas such as ILC where PSMA is expressed but patients are under-served by current imaging techniques.”

OPALESCENCE study in triple negative breast cancer, now recruiting patients

‘OPALESCENCE’, is a Phase II study of Telix’s TLX250-CDx (89Zr-DFO-girentuximab) in patients with triple negative breast cancer (TNBC).

The objective of this study is to evaluate the feasibility of using TLX250-CDx PET/CT to detect CA9 expression as the basis of a potential future therapeutic strategy for TNBC. TNBC is a subtype of breast cancer that has poorer prognosis than other breast cancer subtypes. Identifying new targets and treatment strategies for TNBC is a major unmet need, given the aggressive behaviour and distinct patterns of metastasis that characterise this cancer, and the lack of targeted therapies. The study will be led by Dr. Caroline Rousseau at the Institut de Cancérologie de l’Ouest in St Herblain, France, and will recruit 12 patients.

OPALESCENCE is the second of a comprehensive series of studies that will evaluate CA9 expression in cancers other than clear cell renal cell carcinoma (ccRCC), currently the focus of the ZIRCON (imaging) and STARLITE  (therapy) studies. The goal of these studies is to evaluate how CA9 imaging can be utilised in cancer diagnosis and staging, and to develop a deeper understanding of the utility of CA9 as a therapeutic target in this patient population. It follows a first patient being dosed in June in the ZiP-UP study of patients with urothelial carcinoma or bladder cancer, with other collaborations being developed for head and neck, lung, and pancreatic cancers in order to develop CA9-targeted radiation as a truly pan-cancer approach.

Telix Chief Medical Officer, Dr. Colin Hayward added, “We are privileged to be working with these leading institutions to expedite the evaluation of our technologies in women’s health, and in particular in areas where there is an urgent need to provide better options for patients. Both ILC and TNBC can be extremely aggressive and there are unmet needs in both accurate staging and therapeutic delivery. These investigator-led studies support our goal of rapid indication expansion, alongside executing our near term commercial and clinical goals for TLX591-CDx and TLX250-CDx. We would like to express our gratitude to Dr. Schuster, Dr. Rousseau and their respective clinical teams, as well as the patients that will contribute to these ground-breaking studies.”

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