TLX250 RENAL CANCER
TLX250 targets clear cell renal cell cancer, the most common and aggressive form of kidney cancer.
In 2018 more than 400,000 people worldwide were diagnosed with kidney cancer and more than 175,000 people died from their disease. Kidney cancer is about twice as common in men than women and the risk of developing kidney cancer is also increased by smoking, obesity, high blood pressure and diabetes. There are different types of kidney cancer and Telix’s program is focused on the most common – clear cell renal cell carcinoma (ccRCC), 70-85% of kidney cancers are ccRCC and it has a high risk of metastasis (spreading to other sites in the body). Telix’s kidney cancer companion diagnostic imaging agent (TLX250-CDx) and therapeutic (TLX250) are being developed to improve the detection and treatment of ccRCC.
TLX250-CDx (89Zr-DFO-girentuximab) is an imaging radiopharmaceutical for the imaging of renal cancer with Positron Emission Tomography (PET). TLX250-CDx targets a cell- surface antigen called Carbonic Anhydrase IX (CAIX), a target that is over-expressed in ccRCC. CAIX antigen is present on 90+% of ccRCC cells but is absent from normal kidney tissues. Many patients are diagnosed with an indeterminate renal mass through routine imaging procedures and TLX250-CDx is able to non-invasively determine whether those incidental findings are cancerous or not. Additionally, TLX250-CDx is sensitive to metastatic disease (which also expresses CAIX) and is therefore potentially enormously beneficial to correctly staging patients with ccRCC.
Current clinical activity
TLX250-CDx (imaging) is currently being studied in an international Phase III clinical trial (NCT03849118) and is expected to complete enrolment in late 2019 or early 2020.
TLX250 (177Lu-DOTA-girentuximab) is a therapeutic radiopharmaceutical that uses anti-CAIX girentuximab (just like the imaging application) to deliver a therapeutic dose of targeted radiation to ccRCC. This therapy may also be used in combination with other oncology treatments to increase the overall efficacy of these treatments.
Current clinical activity
TLX250 (therapy), Telix is preparing to commence two Phase II clinical trials to assess the efficacy of TLX250 in combination with current immuno-oncology therapies for ccRCC.
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None of Telix’s product pipeline has received marketing authorization in any jurisdiction. Any use of Telix products is on an investigational basis or for use in approved clinical trials.