Telix Pharmaceuticals (ASX:TLX) has been granted Human Research Ethics Committee (HREC) approval and received Clinical Trial Notification (CTN) clearance by the Therapeutic Goods Administration (TGA) to commence its first-in-human Phase I study of the company’s next generation prostate cancer therapy product TLX592, in patients with advanced prostate cancer.
TLX592 has been developed using Telix’s proprietary RADmAb engineered antibody technology. Like the company’s existing TLX591 antibody development programme, TLX592 targets prostate specific membrane antigen (PSMA), a target that is almost ubiquitously expressed by prostate cancer cells.
TLX592 has been engineered to clear far more rapidly from a patient’s circulation, making it suitable for use as a targeting agent for 225Ac (actinium-225). Actinium is a potent therapeutic alpha (α) emitting radionuclide and treatment with α-emitting radionuclides is commonly referred to “Targeted Alpha Therapy” or “TAT”.
CEO, Dr Chris Behrenbruch, said the Phase I “CUPID” study is a single centre, open-label trial that will evaluate the safety and tolerability, pharmacokinetics, biodistribution and radiation dosimetry of TLX592 in patients with advanced prostate cancer.
We are delighted to have been granted approval to commence the Phase I CUPID study for TLX592,” Dr Behrenbruch said.
“Telix’s proprietary RADmAb technology fundamentally underpins our ability to develop new TAT treatments for patients with metastatic cancer.
“In the case of TLX592, the clinical objective is to treat patients with prostate cancer that have a low disease burden for which alpha therapy is ideally suited, as well as potentially treating patients that no longer respond to conventional lutetium PSMA therapy (177Lu-PSMA).
“Telix has one of the broadest TAT pipelines in the industry and we are pleased to see our R&D efforts heading into the clinic.”
Prostate cancer is the second most common cancer in men following skin cancer and, in 2018, 1.3 million men were diagnosed with prostate cancer for the first time. Despite advances in treatment, prostate cancer still accounts for a large number of deaths and in 2018 more than 365,000 men died from their disease.
Rates of diagnosis are increasing, with the highest incidences of prostate cancer occurring in Europe, the United States, Europe and Australia and New Zealand.