Blue Earth, Seibersdorf expand radiopharmaceutical production deal

Blue Earth Therapeutics has expanded its manufacturing partnership with Seibersdorf Labor to include the production of its investigational 225 Ac-based radioligand therapy. This collaboration aims to guarantee a future supply of the therapeutic radiopharmaceutical for clinical trial sites across the UK, EU, and US.

The investigational radiohybrid (rh) prostate-specific membrane antigen-targeted therapeutic, 225 Ac-rhPSMA-10.1, is the second candidate in Blue Earth’s oncology development program. This program focuses on next-generation therapeutic radiopharmaceuticals designed to target and treat prostate cancer.

David Gauden, CEO of Blue Earth Therapeutics, expressed his satisfaction with the expanded partnership. “We are very pleased to add the manufacture of our 225 Ac-based investigational product to our collaboration with Seibersdorf Labor. This product has the potential to achieve high purity and stability. Our partnership will ensure the supply of clinical trial sites in London and potentially other regions. Seibersdorf has proven to be an excellent and cooperative partner, and we look forward to future projects with them,” Gauden stated.

Radiohybrid prostate-specific membrane antigen (rhPSMA) compounds are engineered to target and be internalized by prostate cancer cells. These compounds can be labeled with imaging isotopes for PET (positron emission tomography) imaging or therapeutic isotopes such as 177Lu or 225Ac for cancer treatment. This offers precision medicine opportunities for men with prostate cancer.

Dr. Markus Neumann, managing director of Seibersdorf Labor, highlighted the significance of the project. “This is our first project utilizing the 225 Ac radioisotope, and we have established dedicated infrastructure and services to support it. We are eager to develop in-house expertise for 225 Ac and expand our projects with Blue Earth Therapeutics to include this new agent. We look forward to delivering doses to treat patients in clinical trials. Blue Earth Therapeutics has been a supportive partner as we expand our capabilities, and we are proud to be part of their network,” Neumann commented.

The radiohybrid technology and rhPSMA were developed at the Technical University of Munich in Germany. In 2018, Blue Earth Diagnostics acquired exclusive global rights to rhPSMA diagnostic imaging technology from Scintomics, followed by securing therapeutic rights in 2020. These rights have been sublicensed to its sister company, Blue Earth Therapeutics. However, Blue Earth Therapeutics’ rhPSMA compounds have yet to receive regulatory approval.

In July 2024, Blue Earth Therapeutics announced a clinical research partnership with University College London. This collaboration aims to conduct a Phase I/II trial to evaluate the safety, tolerability, radiation dosimetry, and anti-tumor activity of 225 Ac-rhPSMA-10.1 in men with metastatic castrate-resistant prostate cancer. This trial represents a significant milestone in assessing the potential of 225 Ac-rhPSMA-10.1 as a therapeutic option for this patient population.

The expansion of Blue Earth Therapeutics’ manufacturing partnership with Seibersdorf Labor underscores the commitment to advancing innovative cancer treatments and ensuring the availability of necessary therapeutic agents for clinical trials worldwide. The collaboration also highlights the ongoing efforts to harness cutting-edge technology for precision medicine in prostate cancer treatment.