🧪 Theranostics Newsletter | 04.2025 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 Secures Commercial-Scale Copper-64 Supply from Nusano for U.S. Rollout
Clarity Pharmaceuticals has signed a major supply agreement with Nusano to ensure large-scale, cost-effective access to copper-64 (⁶⁴Cu) for its Targeted Copper Theranostics. With Nusano’s Utah facility capable of producing over 18,000 patient doses per day, this deal supports Clarity’s late-stage clinical trials and upcoming U.S. commercialization—especially for its lead product, SAR-bisPSMA, targeting prostate cancer. The partnership also strengthens a resilient, U.S.-based supply chain for radiopharmaceuticals in a growing oncology market. Continue reading here.

Curium Acquires Nucleis to Boost PET Radiopharmaceutical Production Across Europe
Curium has acquired Nucleis to significantly expand its PET manufacturing capabilities and strengthen its radiopharmaceutical supply chain across Western Europe. The move enhances access to life-saving PET diagnostics in the Benelux region and Germany, while also accelerating the development of innovative PET tracers in oncology, neurology, and cardiology. With Nucleis’ expertise and Curium’s infrastructure, this acquisition marks a major step forward in advancing precision diagnostics in nuclear medicine. Continue reading here.

Telix Doses First Patient in ZOLAR Trial for Advanced Soft Tissue Sarcoma
Telix Pharmaceuticals has dosed the first patient in its Phase 1 ZOLAR trial, evaluating TLX300-CDx (⁸⁹Zr-olaratumab) for advanced soft tissue sarcoma at the Melbourne Theranostic Innovation Centre. This first-in-human study uses PET imaging to assess safety, biodistribution, and dosimetry, laying the groundwork for future targeted radionuclide therapy against PDGFRα-expressing tumors. The trial aims to inform the optimal therapeutic dose and radionuclide selection for treating this difficult-to-manage cancer. Continue reading here.

Clarity Begins Phase II SECuRE Trial to Advance Theranostics for Prostate Cancer
Clarity Pharmaceuticals has treated the first patient in the Phase II Cohort Expansion of its SECuRE trial, using 67Cu-SAR-bisPSMA in combination with enzalutamide for metastatic castration-resistant prostate cancer. Backed by strong safety and efficacy signals from the Phase I dose escalation, this next phase will explore higher treatment cycles and earlier use in the disease course. The trial also debuts Clarity’s enhanced formulation, optimized for large-scale theranostics production and commercial rollout. Continue reading here.

AdvanCell Secures $18M MRFF Grant to Advance Targeted Alpha Therapy in Prostate Cancer
AdvanCell has received $18 million from Australia’s Medical Research Future Fund (MRFF) Frontiers Initiative to drive a groundbreaking clinical program in prostate cancer. The funding will support the development of a first-in-field platform trial using AdvanCell’s proprietary Lead-212 (²¹²Pb) alpha therapy, aimed at transforming treatment through innovative combinations and faster clinical translation. Collaborating with top researchers across Australia, this initiative could mark a practice-changing shift in the care of prostate cancer patients. Continue reading here.

PharmaLogic to Acquire Agilera, Creating First Global CDMO for Radiopharmaceutical Therapeutics
PharmaLogic is set to acquire a majority stake in Agilera Pharma AS, positioning itself as the only globally integrated CDMO actively producing radiopharmaceutical therapies. This strategic move expands PharmaLogic’s manufacturing capacity, enhances transatlantic distribution, and boosts access to therapeutic radiopharmaceuticals across the U.S., Europe, and Asia. The acquisition underscores a major milestone in scaling up global production and innovation in nuclear medicine. Continue reading here.

Akiram Launches Eurostars-Funded PRE-CISE Project to Advance Targeted Alpha-Therapy
Akiram Therapeutics has initiated the PRE-CISE project, a Eurostars-funded collaboration with PreTT and TetraKit Technologies, to develop next-generation targeted alpha-therapeutics using a novel pre-targeting strategy. By separating the tumor-targeting step from the delivery of the radioactive payload, the approach aims to enhance precision and reduce off-target effects—unlocking the potential of alpha-emitting radionuclides for cancer treatment. The project leverages Akiram’s CD44v6 antibody platform and is expected to deliver preclinical results by 2026. Continue reading here.

Novel Theranostic Antibody Targets IL13Rα2 for Precision Imaging and Therapy in Solid Tumors
A breakthrough radiolabeled antibody targeting IL13Rα2 has shown high specificity for cancer cells while sparing healthy tissue, paving the way for a new theranostics approach to treating solid tumors like glioblastoma and melanoma. Developed and validated in preclinical models, the lead candidate KLG-3 delivered high-contrast PET imaging and promising therapeutic potential with low off-target effects. This innovation marks a major step toward precise, low-toxicity radioimmunotherapy. Continue reading here.

Telix Reports Promising Theranostics Results for TLX101 in Recurrent Glioma
Telix Pharmaceuticals has announced encouraging Phase 2 results from the IPAX-Linz study, showing that its theranostic candidate TLX101 is well tolerated and may improve survival in patients with recurrent high-grade glioma. The study reported a median overall survival of 12.4 months from treatment initiation—outperforming typical outcomes with radiation alone. These findings support TLX101’s continued development and its potential to redefine glioma care through targeted radiotherapy guided by companion imaging. Continue reading here.

Radiopharm Theranostics Doses First Patient in U.S. Phase 2b Brain Metastasis Imaging Study
Radiopharm Theranostics has dosed the first patient in its U.S. Phase 2b trial evaluating 18F-RAD101, a novel theranostics imaging agent targeting fatty acid synthase (FASN) in recurrent brain metastases. The study aims to enhance diagnostic precision compared to standard MRI, helping distinguish true tumor recurrence from treatment effects. Positive early results could transform care for the over 300,000 patients diagnosed with brain metastases annually in the U.S. Continue reading here.

SPECT/CT Plus PSA Shows Strong Theranostics Potential for Monitoring Pluvicto Response
A new study highlights that SPECT/CT imaging combined with PSA levels offers a reliable, cost-effective alternative to PET/CT for evaluating early responses to Lu-177 PSMA (Pluvicto) therapy in prostate cancer patients. Researchers found that SPECT/CT using RECIP 1.0 criteria effectively predicted overall survival, supporting its use in routine theranostics practice without compromising care quality. These findings could simplify and expand access to critical treatment monitoring globally.
Continue reading here.