Blue Earth Therapeutics Progresses Lutetium (177Lu) rhPSMA-10.1 Injection with Positive Phase 1 Results

Blue Earth Therapeutics Ltd, a pioneering company in therapeutic radiopharmaceuticals, has announced significant advancements in its novel investigational radioligand therapies. The Phase 1 trial of Lutetium (177Lu) rhPSMA-10.1 Injection concluded patient enrolment in July, showcasing promising early data. The trial's initial findings indicate a favorable safety profile, with radiation dosimetry for up to three cycles demonstrating high tumor absorbed radiation doses relative to the dose delivered to critical normal organs like the kidneys and salivary glands. Although the final analysis is ongoing, the ratio between radiation dose to tumors versus dose to kidneys and salivary glands is compelling compared to existing data for first-generation radioligand therapies.

This positive data paves the way for the Phase 2 portion of the Phase 1/2 trial, expected to commence later this year. Blue Earth Therapeutics has shared the planned Phase 2 study design with regulators. Subject to the trial safety committee's approval, the study aims to test innovative dosing regimens. Based on the advantageous results observed in Phase 1 regarding absolute tumor and normal organ uptake, Phase 2 will explore several key concepts:

1. Administration of significantly higher overall injected radioactivity compared to recent Phase 3 clinical trials of other agents.
2. Front loading of administered radioactivity.
3. Extending the duration of radioactivity administration to provide a longer treatment period.

Coupled with the positive radiation dosimetry results from Phase 1, these factors are expected to support the ultimate goal of achieving better patient outcomes.

David Gauden, CEO of Blue Earth Therapeutics, expressed enthusiasm about the new data, which supports their best-in-class thesis and provides a clear path to transition from Phase 1 to Phase 2 in developing their leading therapy. The company remains on track to initiate Phase 2 in the upcoming months, with comprehensive Phase 1 results anticipated to be presented at a scientific meeting in 2025.

Dr. Daniel Stevens, Head of Clinical Development and Medical at Blue Earth Therapeutics, highlighted the evolving science which suggests that fixed dosing at fixed intervals may not be optimal. By front loading radioactivity and extending therapy duration, the time to disease progression could be lengthened. These dosing concepts will be explored in Phase 2, with the aim of optimizing dosing to achieve the best possible patient outcomes in future pivotal trials. He emphasized the importance of adapting dosing based on individual patient data for improved results.

The Phase 2 clinical trial of Lutetium (177Lu) rhPSMA-10.1 Injection is planned to be conducted at approximately 15 sites across the US and Europe, enrolling around 70 patients.

The company also discussed the concept of Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds. These compounds are termed "radiohybrid" due to their structure, which includes a Prostate-Specific Membrane Antigen-targeted receptor ligand attached to two labeling moieties. These can be radiolabeled with diagnostic isotopes such as 18F or 68Ga for PET imaging, or with therapeutic isotopes like 177Lu or 225Ac for radioligand therapy. A modifiable linker joins these components, allowing modulation of critical pharmacokinetic characteristics. Radiohybrid PSMA offers potential targeted treatment for men with prostate cancer and originated at the Technical University of Munich, Germany. Blue Earth Diagnostics acquired the exclusive worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018 and therapeutic rights in 2020, later sublicensing the therapeutic application to its sister company, Blue Earth Therapeutics.

Blue Earth Therapeutics is dedicated to advancing next-generation targeted radiotherapeutics for cancer treatment. As part of the Bracco family of companies, it leverages proven management expertise in radiopharmaceutical and oncology drug development to innovate and improve upon current technologies, advancing new targeted therapies for serious diseases, initially focusing on prostate cancer.