225Ac-rhPSMA-10.1 / Bracco, Blue Earth Therapeutics - LARVOL DELTA

ACT-RESoLUTE: A Phase I/II trial of ACTinium225 rhPSMA-10.1 in castration-RESistant prostate cancer after LUTEtium-PSMA (ESMO 2026) - No abstract available

P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Actinium-225-rhPSMA-10.1 as a novel, alpha-particle-emitting therapy for prostate cancer: results of a preclinical evaluation. (PubMed, Front Oncol) - "There were no significant differences in tumour growth suppression or survival between the radiopharmaceuticals, and both were well tolerated. [225Ac]Ac-rhPSMA-10.1 displayed similar in vivo properties to [177Lu]Lu-rhPSMA-10.1 and similar efficacy in prostate cancer xenografts at lower administered radioactivity."

Journal • Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Blue Earth Therapeutics announces first participant dosed in Phase 1 clinical trial investigating Actinium (²²⁵Ac) rhPSMA-10.1 Injection in metastatic castration-resistant prostate cancer (PRNewswire) - "The study is sponsored by UCL and is being conducted at UCL Hospital, London....This Phase 1 study is designed to evaluate the safety and anti-tumour activity of Actinium (225Ac) rhPSMA-10.1 Injection in participants with PSMA‑positive mCRPC whose disease has progressed following prior therapy. Results from the study are expected to characterise the side effects of Actinium (225Ac) rhPSMA-10.1 Injection and to inform dose selection for subsequent research."

Trial status • Castration-Resistant Prostate Cancer

Blue Earth Therapeutics Ltd announces completion of $76.5M Series A financing to accelerate development of next generation targeted radioligand therapies (PRNewswire) - "Blue Earth Therapeutics Ltd...announced closing of a $76.5M Series A financing. The round was led by Soleus Capital and co-led by Sands Capital Management with existing investor Bracco Imaging SpA also participating. Woodline Partners and PBM Capital also joined in the financing as new institutional investors....Resources support Phase 2 studies for Lutetium (177Lu) rhPSMA-10.1 and Actinium (225Ac) rhPSMA-10.1, and development of differentiating data compared to 1st generation prostate cancer radioligand therapies."

Financing • Prostate Cancer

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

Licensing / partnership • Prostate Cancer

Blue Earth Therapeutics Announces Clinical Research Collaboration with UCL to Develop Innovative Alpha-labelled Radioligand Therapy (RLT) for Prostate Cancer (Businesswire) - "Blue Earth Therapeutics...today announced the signing of a clinical research collaboration with University College London (UCL). The collaboration is centered on a Phase 1/2 trial designed to evaluate the safety, tolerability, radiation dosimetry and anti-tumour activity of the company’s 225Ac-rhPSMA-10.1 in men with metastatic castrate-resistant prostate cancer who have previously responded to lutetium 177 (177Lu)-PSMA therapy. The work will be conducted at the UCL Cancer Institute in London, UK, by the Treatment Resistance Group under the leadership of Professor Gerhardt Attard, MD PhD FRCP. "

Licensing / partnership • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Blue Earth Therapeutics Announces Promising Results of Preclinical Evaluation of 225Ac-rhPSMA-10.1 for Potential Targeted Alpha Therapy of Prostate Cancer (Businesswire) - "Blue Earth Therapeutics...announced results from a series of preclinical analyses designed to evaluate the binding affinity, lipophilicity, cellular internalization and therapeutic efficacy of 225Ac-rhPSMA-10.1 in preclinical models for the treatment of prostate cancer, using 177Lu-rhPSMA-10.1 as a comparator. Results showed that both 225Ac-rhPSMA-10.1 and 177Lu-rhPSMA-10.1 demonstrated excellent PSMA binding affinity, high cellular internalization and similar lipophilicity. Therapeutic response and efficacy were evaluated in a preclinical prostate cancer model which showed that 225Ac-rhPSMA-10.1 significantly suppressed tumor growth relative to control."

Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor