First Patient Dosed in CUPID Study of Telix’s Targeted Alpha Therapy Candidate for Prostate Cancer

Melbourne (Australia) – 5 August 2021. Telix announces the first patient has been dosed in its ‘CUPID’ Phase I study of TLX592 in patients with advanced prostate cancer.

Telix is pleased to announce today that the first patient has been dosed in its ‘CUPID’ first-in-human Phase I study of the Company’s next generation prostate cancer therapy candidate TLX592 in patients with advanced prostate cancer.

The objective of the CUPID (⁶⁴Cu PSMA Imaging and (Bio)Distribution) study is to evaluate the safety, tolerability, pharmacokinetics, biodistribution and radiation dosimetry of TLX592. This investigational agent will become Telix’s first targeted alpha therapy (“TAT”) for the treatment of patients with advanced prostate cancer. The CUPID study, which is being conducted in collaboration with GenesisCare, will recruit up to 15 patients and will initially use copper-64 (⁶⁴Cu) to evaluate biodistribution and dosing, before proceeding to studies with actinium-225 (²²⁵Ac) TAT.

TLX592 targets prostate specific membrane antigen (PSMA), as does the Company’s existing TLX591 (¹⁷⁷Lu-rosapatamab) prostate cancer therapy program. However, TLX592 has been engineered with Telix’s proprietary RADmAb^® antibody technology to clear far more rapidly from a patient’s circulation than unmodified antibodies, while maintaining TLX591’s specificity for tumour-expressed PSMA and hepatic (liver) clearance, rendering it potentially more suitable for use as a targeting agent for ²²⁵Ac, a potent therapeutic alpha emitting radionuclide.

Principal Investigator for the CUPID study and GenesisCare Group Clinical Director (Theranostics) Clinical Professor Nat Lenzo stated, “The initiation of the Phase I CUPID PET imaging study represents a significant milestone in the development of next generation alpha particle treatments, a promising new frontier in nuclear medicine, with the potential to significantly improve outcomes for patients. The very high energy, short range properties of targeted alpha therapy have the potential to offer a potent and highly selective anti-cancer therapy to patients with advanced prostate cancer.”

Founder and Chief Executive Officer of GenesisCare, Dan Collins, said: “As one of the largest global providers of integrated cancer care, GenesisCare is uniquely positioned to partner with leading research institutions and pharmaceutical companies on bold new solutions to bring patients world-class cancer care, closer to home. We are proud to partner with Telix Pharmaceuticals on the CUPID trial which may bring new hope to thousands of men living with prostate cancer in Australia and around the globe.”  

Telix CEO, Dr. Christian Behrenbruch added, “One of Telix’s key objectives is to establish category leadership in urologic oncology, thereby being able to offer patients with prostate cancer a broad suite of state-of-the-art diagnostic imaging and therapeutic options. With this objective in mind, TLX592 represents Telix’s most significant proprietary antibody development to date. It is our aim to develop this program for both the early stages of metastatic prostate cancer, as well as for later stage patients no longer responding to lutetium therapy, in tandem with the ¹⁷⁷Lu-based TLX591. We wish to express our gratitude to Professor Nat Lenzo and his clinical collaborators, as well as the patients who have made this important milestone possible.”

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