🧪 Theranostics Newsletter | 01.2025 Edition

Here’s your latest dose of Theranostic Insights—a curated snapshot of what’s new and next in the world of theranostics powered by TheranosticTrials.org. From clinical breakthroughs to tech trends, we’ve got the highlights you need to stay ahead.

Latest Theranostics News 📰

Clarity’s 64Cu-SAR-bisPSMA Shows Early, Accurate Prostate Cancer Detection
Clarity Pharmaceuticals has announced that abstracts from its COBRA and CLARIFY trials, focusing on the diagnostic agent ⁶⁴Cu-SAR-bisPSMA, have been accepted for presentation at the 2025 ASCO GU and AUA conferences. The data demonstrate that ⁶⁴Cu-SAR-bisPSMA detects prostate cancer lesions more effectively and earlier than current PSMA PET agents, identifying lesions as small as 2 mm in 14% of participants. This enhanced detection could significantly influence treatment decisions and improve patient outcomes. Continue reading here.

Standardized FAP PET Imaging Guidelines Released by SNMMI
The Journal of Nuclear Medicine has published a new practice guideline for imaging with fibroblast activation protein (FAP) PET, offering standardized protocols for this promising theranostic tool. Developed by the Society of Nuclear Medicine and Molecular Imaging (SNMMI), the guideline outlines recommended procedures for using FAP-targeted radiopharmaceuticals in oncology, including patient preparation, imaging techniques, and interpretation criteria. As FAP PET gains momentum for its ability to visualize cancer-associated fibroblasts across a range of tumors, this guidance aims to ensure consistency and quality in clinical implementation. Continue reading here.

Nusano and Atley Partner to Scale Astatine-211 Supply for Cancer Therapy
Nusano and Atley Solutions have entered into a memorandum of understanding to co-develop astatine-211 (At-211) solutions for oncology therapeutics. Nusano's upcoming facility in Utah, opening in 2025, is set to increase the global supply of At-211 by 100 times, addressing current limitations due to the isotope's short half-life. Atley Solutions brings expertise in scalable manufacturing of At-211 radiolabeled compounds, aiming to standardize production for broader clinical use. This collaboration seeks to establish reliable supply chains for At-211 radiopharmaceuticals, potentially benefiting various patient groups worldwide. Continue reading here.

ITM-11 Surpasses Standard of Care in Phase 3 GEP-NET Trial
ITM Isotope Technologies has announced that ITM-11 significantly outperformed the current standard of care in a pivotal phase 3 trial, marking a major step forward in targeted radiotherapy. The therapy demonstrated superior progression-free survival in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), potentially setting a new benchmark in treatment efficacy. Traditionally known as a radiopharmaceutical manufacturer, ITM’s success in this trial positions the company as a major player in theranostic drug development. The company plans to seek regulatory approval later this year. Continue reading here.