First Patient Dosed in ProstACT Program for Prostate Cancer Therapy

Melbourne (Australia) – 27 January 2022. Telix announces that the first patient has been dosed in the Company’s PSMA-targeting ‘ProstACT’ therapeutic program.

Telix is pleased to announce that the first patient has been dosed in the Company’s prostate-specific membrane antigen (PSMA) targeting ‘ProstACT’ therapeutic program, which is exploring TLX591 in areas of unmet medical need across the full prostate cancer treatment journey.

Telix’s ProstACT study program is evaluating the efficacy of Telix’s lutetium-177 (¹⁷⁷Lu)-labelled therapeutic antibodies in all stages of prostate cancer, from first recurrence to advanced metastatic disease (known as metastatic castrate-resistant prostate cancer, or mCRPC).

The first patient, dosed at Princess Alexandra Hospital in Brisbane, Queensland, was treated as part of the ProstACT SELECT clinical trial, a Phase I radiogenomics study running concurrently to the pivotal Phase III study, ProstACT GLOBAL.

The goal of ProstACT SELECT is to compare ⁶⁸Ga-PSMA (gallium-based imaging) and ¹⁷⁷Lu-PSMA (lutetium-based therapy), specifically exploring the biodistribution and tumour uptake of small molecule and antibody-based targeting in men with PSMA-expressing mCRPC. Demonstrating the “theranostic” approach, the study is designed to inform optimal patient selection for ¹⁷⁷Lu antibody therapy, with the goal of enabling indication expansion for Telix’s PSMA therapeutic portfolio. ProstACT SELECT is a multi-centre study and will enrol up to 50 patients and is expected to take approximately 12 months to complete.

Principal Investigator for the ProstACT SELECT study and Consultant Medical Oncologist at Princess Alexandra Hospital, Professor Kenneth O’Byrne said, “PSMA-targeting is widely considered to be the vanguard of prostate cancer treatment and we are therefore excited to have dosed a first patient in this important series of studies of Telix’s lead candidate for prostate cancer therapy.  The ProstACT study builds on an already significant body of clinical data for TLX591, which has potential to transform patient outcomes across the full prostate cancer treatment journey.”

Along with ProstACT TARGET, the third study in the program to run concurrently to the SELECT and GLOBAL studies, the program will inform the Company’s clinical and commercialisation strategies for the TLX591 therapeutic candidate and generate multiple opportunities for near-term data readouts throughout the program duration. Proceeds from the recent capital raise will be applied to the completion of the ProstACT studies.

Telix Chief Medical Officer Dr. Colin Hayward added, “Dosing a first patient in the ProstACT program is a significant milestone for Telix. SELECT is part of the Company’s clinical and commercial strategy to develop TLX591 across multiple points from early-stage, localised disease all the way through to advanced metastatic disease. This study will add value and clinical insight to the platform, whilst also supporting potential indication expansion based on a ‘theranostic’ approach. We wish to express our gratitude to Professor Kenneth O’Byrne and his clinical team, as well as the patients who will contribute to the study.”

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