Telix (ASX:TLX) has announced the successful completion of CUPID, a first-in-human Phase 1 dose escalation study of TLX592 in patients with advanced prostate cancer.
TLX592 is the company's investigational next-generation targeted alpha therapy (TAT) for the treatment of prostate cancer.
It is the first clinical program to utilise Telix's RADmAb-engineered antibody technology. The company said the RADmAb approach accelerates blood clearance and reduces bone marrow residence time compared with standard monoclonal antibodies (mAbs) while retaining target selectivity, internalisation, and retention. The RADmAb platform is currently under pre-clinical and clinical evaluation for multiple cancer targets.
The CUPID study is a 3+3 mass dose escalation study with four patient cohorts intended to evaluate the safety, tolerability, pharmacokinetics, biodistribution and radiation dosimetry of TLX592. Preliminary results in 11 evaluable enrolled patients demonstrated accelerated blood kinetics compared to the standard antibody TLX591 while demonstrating similar on-target and off-target biodistribution and hepatic clearance. There were no serious adverse events observed in the study.
Telix said it expects to advance TLX592 into a therapeutic Phase I/II study with 225Ac in the second half of 2024, subject to regulatory approval.
Telix group chief medical officer Dr David Cade said, "The CUPID study demonstrated clearly how theranostic approaches can be used to streamline novel radiopharmaceutical drug development. In this case, PET imaging was used to dose-find a targeting agent for future use with an alpha emitter, while establishing basic safety and utility parameters that will greatly inform ongoing development of this product candidate.
"There is a significant unmet need for novel targeting platforms that may be used with alpha emitting isotopes and avoid renal toxicity and other off-target effects, such as the exocrine gland uptake typical of PSMA small molecule agents. We are excited to progress TLX592 into therapeutic studies where our aim is to develop this agent for both early metastatic prostate cancer and late-stage patients who are no longer responding to lutetium therapy. We would like to thank all participants for their commitment to the CUPID study."
