TLX250 RENAL CANCER
TLX250 targets clear cell renal cell cancer, the most common and aggressive form of kidney cancer.
In 2020, more than 430,000 people worldwide were diagnosed with kidney cancer and nearly 180,000 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 investigational diagnostic imaging agent (TLX250-CDx) and therapeutic candidate (TLX250) are being developed to target a cell-surface antigen called carbonic anhydrase IX (CA9), a cancer target that is overexpressed in ccRCC due to a mutation of the von Hippel-Lindau (VHL) protein. CA9 is present on 90+% of ccRCC cells but is absent from normal kidney tissues and is therefore an attractive target for both imaging and therapy.
TLX250-CDx (89Zr-DFO-girentuximab) is an investigational radiopharmaceutical for the imaging of renal cancer with positron emission tomography (PET). Many patients are diagnosed with an indeterminate renal mass through routine imaging procedures and TLX250-CDx has the potential to non-invasively determine whether those incidental findings are cancerous or not. This could reduce the need for renal biopsy and the proportion of partial or radical nephrectomies performed to remove localized renal masses that are subsequently shown to have benign or indolent histopathology.
Current clinical activity
TLX250-CDx (imaging) is currently the subject of a global Phase III clinical trial (NCT03849118) and is expected to complete enrolment in early 2022.
TLX250 (177Lu-DOTA-girentuximab) is an investigational therapeutic radiopharmaceutical that uses anti CA9 girentuximab (just like the imaging application) to deliver a therapeutic dose of targeted radiation to ccRCC. This therapy candidate may also be used in combination with other oncology treatments to increase the overall efficacy of these treatments.
Current clinical activity
TLX250 (therapy), Telix has recently commenced the first of two Phase II clinical trials (STARLITE 1 and 2) to assess the efficacy of TLX250 in combination with current immuno-oncology therapies for ccRCC.
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With the exception of Telix’s 68Ga PSMA-11 imaging agent in Australia and the United States, none of Telix’s products have received a marketing authorisation in any jurisdiction. Any use of Telix products is on an investigational basis only.