Telix Initiates First-in-Human Study of TLX300-CDx in Advanced Soft Tissue Sarcoma

Telix Announces First Patient Dosed in First-in-Human ZOLAR Trial of TLX300-CDx in Advanced Soft-Tissue Sarcoma

MELBOURNE, Australia, April 1, 2025 - Telix Pharmaceuticals Limited (Telix), a global biopharmaceutical company, today announced that the first patient has been dosed in the ZOLAR (Zoledronate and Telix's Lymph Node Assessment by Radionuclide) trial, a first-in-human study evaluating the company's TLX300-CDx in patients with advanced soft-tissue sarcoma.

The ZOLAR trial is a Phase 1, open-label, multi-center study designed to assess the safety, tolerability, and efficacy of TLX300-CDx, a novel radiolabeled antibody-drug conjugate (ADC) targeting CD73, in patients with advanced soft-tissue sarcoma. The trial will enroll up to 20 patients with unresectable or metastatic soft-tissue sarcoma who have progressed on or are intolerant to standard therapies.

TLX300-CDx is a next-generation ADC that combines a proprietary antibody targeting CD73 with a novel small molecule payload. The compound has shown promising preclinical data, demonstrating potent anti-tumor activity and a favorable safety profile.

"We are thrilled to announce the first patient dosed in the ZOLAR trial, marking an important milestone in our efforts to bring TLX300-CDx to patients with advanced soft-tissue sarcoma," said Dr. Tyler Golino, Chief Medical Officer at Telix. "This trial will provide valuable insights into the safety and efficacy of TLX300-CDx, and we look forward to sharing the results with the scientific community and regulatory authorities."

The ZOLAR trial is being conducted at multiple sites in the United States and Australia, and is expected to be completed in 2025. The primary endpoint of the trial is to assess the safety and tolerability of TLX300-CDx, with secondary endpoints evaluating efficacy and overall survival.

About Telix Pharmaceuticals Limited Telix Pharmaceuticals Limited (ASX: TLX) is a global biopharmaceutical company focused on the development and commercialization of innovative radiopharmaceuticals and companion diagnostics for the treatment of cancer and rare diseases. The company's pipeline includes TLX250-CDx, a radiolabeled antibody-drug conjugate targeting CD244, and TLX300-CDx, a novel radiolabeled antibody-drug conjugate targeting CD73. For more information, visit www.telix.com.