Blue Earth Therapeutics Announces Promising Results of Preclinical Biodistribution and Efficacy Evaluation of 177Lu-rhPSMA-10.1 in Treatment of Prostate Cancer

− ¹⁷⁷Lutetium-labelled radiohybrid Prostate-Specific Membrane Antigen (¹⁷⁷Lu-rhPSMA-10.1) is in development as a highly optimized, next generation therapeutic radiopharmaceutical –

− ¹⁷⁷Lu‑rhPSMA-10.1 demonstrated favorable tumor:kidney ratio and statistically significant tumor growth suppression in preclinical studies −

− Phase 1/2 clinical trial of ¹⁷⁷Lu-rhPSMA-10.1 in men with metastatic castrate‑resistant prostate cancer recently cleared to proceed in United States −

Excerpt from the Press Release:

June 14, 2022 08:30 AM Eastern Daylight Time

OXFORD, England & BURLINGTON, Mass.–(BUSINESS WIRE)–Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, today announced results from a series of preclinical analyses designed to evaluate the biodistribution and potential therapeutic efficacy of ¹⁷⁷Lu-rhPSMA-10.1 and ¹⁷⁷Lu-PSMA-I&T in the treatment of prostate cancer preclinical models. Results from preclinical biodistribution studies demonstrated that ¹⁷⁷Lu‑rhPSMA-10.1 performed favorably when compared with ¹⁷⁷Lu-PSMA-I&T, with an improved tumor:kidney uptake ratio. Therapeutic efficacy was evaluated in a preclinical prostate cancer xenograft model which showed that ¹⁷⁷Lu‑rhPSMA‑10.1 significantly suppressed tumor growth relative to control, and to a greater extent than ¹⁷⁷Lu-PSMA-I&T. The data were presented in an oral presentation at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting. ¹⁷⁷Lu-rhPSMA-10.1 is an investigational radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted therapeutic radiopharmaceutical, and the lead candidate in Blue Earth Therapeutics’ oncology development program of next generation therapeutic radiopharmaceuticals.

“Radioligand therapy targeting prostate-specific membrane antigen (PSMA) has been shown to be an effective therapy in men with metastatic castration-resistant prostate cancer,” said Caroline Foxton, Ph.D., Vice President R&D Strategy and Collaboration at the Blue Earth Group. “However, optimizing tumor uptake and accelerating renal clearance for this class of compounds could improve the therapeutic index, achieve better clinical outcomes and effectively manage radiation exposure to patients. Blue Earth Therapeutics’ next generation therapeutic rhPSMA compound has been optimized for favorable biodistribution properties to enhance delivery of therapeutic radiation to tumors while minimizing kidney uptake and retention. Supported by these preclinical data, ¹⁷⁷Lu‑rhPSMA-10.1 was selected as our lead therapeutic candidate for progression to the clinic.”

“We are pleased that the first presentation of preclinical results from Blue Earth Therapeutics’ rhPSMA-10.1 program in prostate cancer is being made to the nuclear medicine community at the SNMMI 2022 Annual Meeting,” said David E. Gauden, D.Phil., Chief Executive Officer of the Company. “Radiohybrid PSMA technology enables utility as a theranostic because the molecule may be modified and deployed for either diagnostic PET imaging or therapeutic applications. This optimized rhPSMA technology can also be developed with both beta- and alpha-emitting therapeutic radioisotopes, with the potential to deliver personalized, targeted therapy specific to each patient’s condition. We are closely collaborating in the development of ¹⁷⁷Lu-rhPSMA-10.1 with our sister company, Blue Earth Diagnostics, by incorporating its investigational ¹⁸F-rhPSMA-7.3 PET agent into our clinical development program.”

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