Blue Earth Therapeutics Ltd Announces Expansion of Partnership With Seibersdorf Labor GmbH to Include Manufacture of Therapeutic Radiopharmaceutical, 225Ac-rhPSMA-10.1

− Manufacturing collaboration will support recently announced research collaboration with University College London to progress a Phase 1/2 clinical trial with Actinium (225Ac) rhPSMA-10.1 in treatment of metastatic castrate resistant prostate cancer

− This extends existing arrangements between Seibersdorf and Blue Earth Therapeutics for manufacture of Lutetium (177Lu) rhPSMA-10.1

OXFORD, England--(BUSINESS WIRE)--Blue Earth Therapeutics Ltd, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, today announced an expansion of its manufacturing agreements with Seibersdorf Labor GmbH to include manufacture of its investigational 225Ac-based radioligand therapy. The agreement provides future supply to UK, EU and US clinical trial sites. (225Ac) rhPSMA‐10.1, an investigational radiohybrid (rh) Prostate‐Specific Membrane Antigen‐targeted therapeutic radiopharmaceutical, is the second candidate in Blue Earth Therapeutics’ oncology development program of next generation therapeutic radiopharmaceuticals.

“We are very pleased to add manufacture of our 225Ac-based investigational product to our partnership with Seibersdorf Labor,” said David E. Gauden, DPhil., Chief Executive Officer of Blue Earth Therapeutics Ltd. “It has the potential to be a product of high purity and stability, and this partnership will enable supply of the clinical trial sites in London, and other regions if necessary. Seibersdorf has been an excellent and collaborative partner, and we look forward to working with them on many more projects in the future.”

“This is our first project using the 225Ac radioisotope and we have implemented dedicated infrastructure and services to support it,” said Dr. Markus Neumann, Managing Director of Seibersdorf Labor GmbH. “We are excited to take on the challenge of developing in-house expertise for 225Ac and expand our projects with Blue Earth Therapeutics to include this new agent and look forward to delivering doses to treat patients in clinical trials. Blue Earth Therapeutics has been a very supportive partner as we expand our capabilities, and we are proud to be part of their network.”

About Radiohybrid Prostate‐Specific Membrane Antigen (rhPSMA)

Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds consist of a radiohybrid (“rh”) Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and they may be radiolabeled with imaging isotopes for PET imaging, or with therapeutic isotopes such as 177Lu or 225Ac for therapeutic use. They 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. Currently, Blue Earth Therapeutics’ rhPSMA compounds have not received regulatory approval.

About Blue Earth Therapeutics

Blue Earth Therapeutics, one of the Bracco family of companies, is a clinical stage company dedicated to advancing next generation targeted radiotherapeutics to treat patients who have cancer. With proven management expertise across the spectrum of radiopharmaceutical and oncology drug development, as well as biotechnology start‐up experience, the Company aims to innovate and improve upon current technologies and rapidly advance new targeted therapies for serious diseases. Blue Earth Therapeutics has an emerging pipeline initially focused on prostate cancer. Blue Earth Therapeutics is an indirect subsidiary of Bracco Imaging S.p.A, and based in Oxford, UK. For more information, please visit: https://www.blueearththerapeutics.com.

About Bracco Imaging

Bracco Imaging S.p.A., part of the Bracco Group, is a world‐leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X‐ray imaging (including Computed Tomography‐CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose‐management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting‐edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: www.braccoimaging.com.

About Seibersdorf Laboratories

Seibersdorf Labor GmbH is specialized in high quality laboratory and analysis work, application-oriented research and development as well as consulting and training.

The teams of Seibersdorf Laboratories are service, know-how and technology providers and cover a broad range of scientific expertise: systems development, production and quality control of radiopharmaceuticals, anti-doping and forensic analyses, radiation protection, ionizing and non-ionizing radiation, radio frequency engineering and electromagnetic compatibility. The experts of Seibersdorf Laboratories represent Austria on various international committees.

For more information, visit: www.seibersdorf-laboratories.at