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MELBOURNE - Telix Pharmaceuticals Limited (ASX: TLX; NASDAQ: TLX), a pharmaceutical company with a market capitalization of $5.58 billion and strong financial health according to InvestingPro metrics, has initiated the Phase 1 ZOLAR1 trial, dosing the first patient with TLX300-CDx (89Zr-olaratumab) for advanced soft tissue sarcoma (STS) treatment at the Melbourne Theranostic Innovation Centre (MTIC), the company announced on Monday. This trial marks the first-in-human study of olaratumab as a therapeutic radiopharmaceutical targeting platform, leveraging positron emission tomography (PET) for evaluation.
The purpose of the ZOLAR trial is to assess the safety, pharmacokinetics, biodistribution, and dosimetry of TLX300-CDx and to determine the optimal dose for patients with advanced STS. This trial is expected to inform the selection of a therapeutic radionuclide for future studies based on the theranostic approach, which combines therapy and diagnostics.
Olaratumab, a monoclonal antibody, targets the platelet-derived growth factor receptor alpha (PDGFRα), which is often over-expressed in STS. The drug was originally developed by Eli Lilly and Company and had received "Accelerated Approval" in the U.S. and "Conditional Approval" in the EU before being voluntarily withdrawn from the market after failing to improve survival in the Phase 3 ANNOUNCE clinical trial. Telix secured exclusive worldwide rights to develop and commercialize radiolabelled forms of olaratumab in April 2022.
Professor Rodney Hicks, Founder, Chair, and Chief Medical Officer at MTIC, and Principal ZOLAR Investigator, highlighted the challenges of treating sarcomas, particularly once they have spread, and expressed optimism about the potential of targeted radionuclide therapy to treat disseminated disease. Dr. David N. Cade, Telix Group Chief Medical Officer, emphasized the importance of the trial in determining the candidate’s potential efficacy and safety profile.
STS is a group of rare cancers with over 50 malignant histological subtypes. In the U.S., it is estimated that there will be approximately 13,520 new diagnoses and 5,420 deaths from STS in 2025. Standard treatments include surgery, radiation therapy, and chemotherapy, but the prognosis for patients with advanced, unresectable, or metastatic disease remains poor. Telix’s strong financial position, with a healthy current ratio of 2.78 and impressive revenue growth of 55.85% over the last twelve months, positions it well to advance this clinical program. InvestingPro analysis reveals 15+ additional insights about Telix’s financial strength and market position.
Telix Pharmaceuticals, headquartered in Melbourne, focuses on developing therapeutic and diagnostic radiopharmaceuticals to address unmet medical needs in oncology and rare diseases. With a robust gross profit margin of 61.79% and a unanimous Strong Buy rating from analysts, the company demonstrates solid operational efficiency. The information provided is based on a press release statement from Telix Pharmaceuticals Limited and financial data from InvestingPro, which indicates the stock is currently trading slightly above its Fair Value.
In other recent news, Telix Pharmaceuticals Limited announced the U.S. Food and Drug Administration’s approval of its new prostate cancer imaging agent, Gozellix®. This agent, designed for PET scanning, is intended to detect PSMA-positive lesions in men with suspected metastatic prostate cancer. The approval is expected to improve access to cutting-edge PSMA-PET imaging in the United States, with Telix anticipating full reimbursement for Gozellix®. Additionally, Telix Pharmaceuticals has completed the acquisition of ImaginAb’s biologics technology platform and therapeutic candidates for an upfront cost of $45 million. This acquisition includes a research facility in Los Angeles and aims to enhance Telix’s position in precision medicine. The deal involves an initial cash payment and equity, with potential additional payments based on milestone achievements. Telix’s acquisition is expected to expand its therapeutic pipeline and research capabilities, particularly in cancer targeting.
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