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October 19, 2022 — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced the signing of a data-sharing agreement with Siemens Healthineers and the University Hospital of the Technical University of Munich (TUM) for anonymized 18F-rhPSMA-7.3clinical data and images. Siemens Healthineers plans to evaluate the data to enhance its analytics and artificial intelligence (AI)-based algorithms for prostate cancer across its advanced PET/CT imaging software. 18F-rhPSMA-7.3 is an investigational radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted PET imaging agent in development by Blue Earth Diagnostics for diagnostic imaging of newly diagnosed and biochemically recurrent prostate cancer.
“Blue Earth Diagnostics is committed to helping men with prostate cancer across the care continuum, and we recognize the importance of AI in advancing healthcare,” said David Gauden, D.Phil., Chief Executive Officer, Blue Earth Diagnostics. “AI-based algorithms have the potential to streamline the PET/CT analytical workflow for hospitals and imaging centers, by efficiently providing physicians with information critical to patient management and care, and freeing them to spend more time with patients. Blue Earth has a long-standing relationship with Siemens Healthineers, a leading medical technology company pioneering breakthroughs in healthcare. We are excited to collaborate on this project to facilitate provision of anonymized 18F-rhPSMA-7.3 data from TUM which will be used to enhance the analytical workflows for the Siemens Healthineers Biograph and syngo.via platforms. The project includes evaluation of diagnostic analytical techniques for 18F-rhPSMA-7.3 data as well as exploring their theranostic potential in radiopharmaceutical therapy. Looking forward, we also plan to make analytical data from Blue Earth Diagnostics’ Phase 3 clinical trials for 18F-rhPSMA-7.3 available, which includes robust histopathology data as the gold Standard of Truth.”
The agreement covers use of anonymized 18F-rhPSMA-7.3 PET/CT data from TUM by Siemens Healthineers to evaluate workflow improvements for image acquisition and interpretation; dose optimization; detection of small metastases and recurrent tumors; evaluation of patients in earlier stages of disease progression and stratification by low PSA levels; and, together with histopathology, assessment of the sensitivity of results. The data will also be used to define and optimize 18F-rhPSMA-7.3 workflow prior to PSMA-targeted radioligand therapy in prostate cancer, to assess its theranostic potential in therapeutic dose planning and the likelihood of treatment success.
“The TUM experience with rhPSMA has allowed us to investigate the potential performance of a new class of theranostic PSMA-targeting agents that enable efficient labelling with radioisotopes such as 18F for PET imaging or 177Lu for therapeutic use,” said Matthias Eiber, MD, PhD, Department of Nuclear Medicine, Klinikum rechts der Isar, TUM. “We are happy that 18F-rhPSMA-7.3 PET/CT imaging scans performed at TUM as part of routine patient care in prostate cancer can be part of this project to inform AI-based algorithms for improved PET/CT workflows. The use of AI has the potential to markedly improve the quality of PET/CT as well as enhance the ability to interpret the scans and follow lesions over time. This will hopefully lead to expanded clinical use cases for this valuable technology, leading to better patient care.”
“We are pleased to collaborate with Blue Earth Diagnostics and TUM on this data-sharing agreement for 18F-rhPSMA-7.3,” said Bruce Spottiswoode, Director, Clinical Applications Research, Siemens Healthineers. “These data will help us optimize the acquisition and processing of 18F-based PSMA imaging and therapeutic radiopharmaceuticals across our family of PET/CT scanners and reading solutions.”
About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)
rhPSMA compounds are referred to as radiohybrid (“rh”), as each molecule possesses three distinct domains. The first consists of a Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells. It is attached to two labelling moieties which may be radiolabeled with either 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. They may play an important role in patient management in the future, and offer the potential for precision medicine for men with prostate cancer. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics has completed two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in prostate cancer: (“LIGHTHOUSE,” NCT04186819), in men with newly diagnosed prostate cancer, and “SPOTLIGHT,” NCT04186845), in men with recurrent disease. Currently, rhPSMA compounds have not received regulatory approval.
For more information: www.blueearthdiagnostics.com
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