Telix Pharmaceuticals Limited (ASX: TLX) has announced the successful completion of the CUPID Phase I dose escalation study of TLX592, marking a significant advancement in targeted alpha therapy (TAT) for prostate cancer. This milestone is especially noteworthy as TLX592 incorporates Telix’s proprietary RADmAb engineered antibody technology, promising a new era in cancer treatment efficacy and safety.

Breakthrough in Prostate Cancer Therapy

The study named CUPID (64Cu PSMA Imaging and (Bio) Distribution) is a crucial step in the development of TLX592, which is designed to treat advanced prostate cancer using a next-generation approach. The 3+3 mass dose escalation study involved four patient cohorts to evaluate the safety, tolerability, pharmacokinetics, biodistribution, and radiation dosimetry of TLX592. Utilizing copper-64 detectable by Positron Emission Tomography (PET), the study served as a proof-of-targeting and helped in predictive dosimetry calculations for future studies with actinium-225 (225Ac).

Preliminary results from the 11 evaluable patients have shown that TLX592 demonstrates accelerated blood kinetics compared to standard monoclonal antibodies, while maintaining favorable on-target and off-target biodistribution and hepatic clearance. Importantly, the study reported no serious adverse events, indicating a promising safety profile for TLX592.

Next Steps for TLX592

Encouraged by these positive outcomes, Telix Pharmaceuticals is planning to transition TLX592 into a therapeutic Phase I/II study with 225Ac in the second half of 2024, pending regulatory approval. This progression is not only a testament to the potential of TLX592 but also enhances Telix’s prostate cancer therapy portfolio, which includes its lead investigational radio antibody-drug conjugate (rADC) TLX591, currently under investigation in the ProstACT GLOBAL Phase III study.

Dr. David N. Cade, Group Chief Medical Officer at Telix, emphasized the significance of the CUPID study’s theranostic approach, which streamlined the novel radiopharmaceutical drug development. He highlighted the potential of TLX592 to address the unmet need for novel targeting platforms that minimize renal toxicity and other off-target effects commonly associated with PSMA small molecule agents.

The success of TLX592 could revolutionize treatment for both early metastatic and late-stage prostate cancer patients who are no longer responding to lutetium therapy. Telix’s commitment to advancing prostate cancer treatment is evident in their plans to publish and present the supporting non-clinical and clinical data at several upcoming symposia.

As Telix Pharmaceuticals prepares to further develop TLX592, the oncology community watches closely, hopeful for a new tool in the fight against prostate cancer that combines efficacy with enhanced safety profiles.

  cancer research, Phase I study, Prostate cancer, prostate cancer treatment, targeted alpha therapy, Telix Pharmaceuticals, TLX592