Blue Earth Therapeutics has broadened its manufacturing collaboration with Seibersdorf Labor to include the production of its investigational 225Ac-based radioligand therapy.
The expansion aims to ensure a future supply of the therapeutic radiopharmaceutical for clinical trial sites in the UK, EU and US.
An investigational radiohybrid (rh) prostate-specific membrane antigen-targeted therapeutic, 225Ac-rhPSMA-10.1 is the second candidate in Blue Earth’s oncology development programme of next-generation therapeutic radiopharmaceuticals.
Blue Earth Therapeutics CEO David Gauden said: “We are very pleased to add manufacture of our 225Ac-based investigational product to our partnership with Seibersdorf Labor.
“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.”
Radiohybrid prostate-specific membrane antigen (rhPSMA) compounds are designed to target and be internalised by prostate cancer cells.
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By GlobalDataThey can be labelled with imaging isotopes for PET [positron emission topography] imaging or therapeutic isotopes such as 177Lu or 225Ac for cancer treatment, offering precision medicine opportunities for men with prostate cancer.
Seibersdorf Labor managing director Dr Markus Neumann stated: “This is our first project using the 225Ac radioisotope and we have implemented dedicated infrastructure and services to support it.
“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.”
The radiohybrid technology and rhPSMA were developed at the Technical University of Munich, Germany.
In 2018, Blue Earth Diagnostics acquired exclusive global rights to rhPSMA diagnostic imaging technology from Scintomics, and in 2020, it secured therapeutic rights.
These rights have been sublicensed to its sister company, Blue Earth Therapeutics.
However, Blue Earth Therapeutics’ rhPSMA compounds are yet to receive regulatory approval.
In July 2024, Blue Earth Therapeutics announced a clinical research partnership with University College London. The collaboration will focus on a Phase I/II trial to assess the safety, tolerability, radiation dosimetry, and anti-tumour activity of 225Ac-rhPSMA-10.1 in men with metastatic castrate-resistant prostate cancer.