On February 20, 2024 Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, reported the publication of promising early clinical data with 177Lu-rhPSMA-10.1 from independent clinical experience by physicians at the University Hospital Augsburg, Germany (Press release, Blue Earth Therapeutics, FEB 20, 2024, View Source [SID1234640308]).

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NOTE: this early clinical experience with 177Lu-rhPSMA-10.1, manufactured by the University Hospital Augsburg and used under German legislation, reflects use of an investigational agent for which safety and efficacy have not been established by the U.S. Food and Drug Administration.

The manuscript, "First Safety and Efficacy Data with the Radiohybrid 177Lu-rhPSMA-10.1 for the Treatment of Metastatic Prostate Cancer," has been published in the Journal of Nuclear Medicine (DOI View Source). In the 4 consecutive patients with metastatic prostate cancer who were evaluated, when looking at radiologic progression free survival (rPFS), 2 patients had not progressed at 24 and 18 months of follow-up. The other 2 patients had a rPFS of 12 and 15 months, respectively. Starting prostate-specific antigen (PSA) levels were reduced by 100%, 99%, 88% and 35% for the 4 individual patients. There were no serious treatment-related adverse events.

177Lu-rhPSMA-10.1 is an investigational radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted radiopharmaceutical for the treatment of prostate cancer, and the lead candidate in Blue Earth Therapeutics’ development of next generation therapeutic radiopharmaceuticals. The Company’s investigational Phase 1/2 clinical trial (NCT05413850) evaluating the safety, tolerability, dosimetry and anti-tumor activity of 177Lu-rhPSMA-10.1 in eligible men with metastatic castrate-resistant prostate cancer (mCRPC) is underway in the United States.

"Although this experience with 177Lu-rhPSMA-10.1 represents a small number of patients, we find the results encouraging, with durable radiologic responses for patients with metastatic castrate resistant prostate cancer, including a complete response to therapy sustained beyond two years," said Prof. Dr. med. Constantin Lapa, Department of Nuclear Medicine, University Hospital, Augsburg, Germany. "This followed our previous dosimetry work with the same patients, which showed that 177Lu-rhPSMA-10.1 achieved a high Therapeutic Index (TI), delivering a high dose to tumors relative to the absorbed dose to the kidneys, and we look forward to the results of Blue Earth Therapeutics’ ongoing Phase 1/2 trial."

"We are pleased that these exciting data, from University Hospital Augsburg’s independent experience with 177Lu-rhPSMA-10.1, have been made available to the physician community," said David Gauden, D. Phil., Chief Executive Officer of Blue Earth Therapeutics. "These promising clinical data give us further optimism in advancing 177Lu-rhPSMA forward in clinical development, with the hope to help treat patients with metastatic prostate cancer. 177Lu-rhPSMA-10.1 is based on innovative radiohybrid PSMA theranostic technology, with a carefully optimized pharmacokinetic profile designed to increase retention in cancer deposits while encouraging clearance from normal tissues as rapidly as possible. We then match these properties with long-lived isotopes to maximize the therapeutic index and dose to tumor."