Investigational Therapeutic Radiopharmaceutical Shows Promise in Treating Prostate Cancer

Blue Earth Therapeutics announced highlights from early clinical and preclinical studies of its investigational therapeutic radiopharmaceutical 177Lutetium-labeled radiohybrid (rh) Prostate-Specific Membrane Antigen (177Lu-rhPSMA-10.1) at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting this month in Chicago.

The preclinical efficacy results in prostate cancer xenografts support a promising therapeutic profile for this investigational medicine. Researchers have observed an average 3.3-fold higher tumor absorbed radiation dose compared to PSMA-I&T in a direct intra-patient comparison, without a proportional increase in radiation dose to the kidney. 

177Lu-rhPSMA-10.1 is an investigational radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted therapeutic radiopharmaceutical for the treatment of prostate cancer. In the presentations, Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, included results from an independent clinical study conducted by the University of Augsburg that investigated dosimetry and the therapeutic index for 177Lu-rhPSMA-10.1. Also being presented were results of Blue Earth Therapeutics’ preclinical studies that examined the therapeutic dose response of 177Lu-rhPSMA-10.1 and the therapeutic efficacy of 177Lu-rhPSMA-10.1 as compared to several other compounds.

177Lu-rhPSMA-10.1 is the first clinical candidate in Blue Earth Therapeutics’ oncology development program of advanced targeted therapeutic radiopharmaceuticals. An 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.

“We are pleased to share these initial results from Blue Earth Therapeutics’ rhPSMA-10.1 program in prostate cancer with the nuclear medicine community at the SNMMI 2023 Annual Meeting,” said David E. Gauden, D.Phil., Chief Executive Officer of the company. “Our goal at Blue Earth Therapeutics is to deliver precise, targeted therapy specific to the patient’s condition. The radiohybrid PSMA theranostic technology platform enables molecules within the class to be modified and deployed for either diagnostic PET imaging or therapeutic applications, and can also be developed with both beta- and alpha-emitting therapeutic radioisotopes. Our lead therapeutic compound, 177Lu-rhPSMA-10.1, was carefully optimized during development with the aim of maximizing its therapeutic index by delivering high radiation doses to prostate cancer lesions while sparing normal tissues as far as possible. The preclinical efficacy results in prostate cancer xenografts reported here support a promising therapeutic profile for 177Lu-rhPSMA-10.1. They are further supported by the early clinical experience of our collaborators in Augsburg, where the team observed an average 3.3-fold higher tumor absorbed radiation dose compared to PSMA-I&T in a direct intra-patient comparison, without a proportional increase in radiation dose to the kidney.”