Patents expand production of Gallium-68 for prostate cancer

Ariceum Therapeutics has granted US and Canadian patents covering its Gallium-68 (Ga-68) radiopharmaceutical production kit for prostate-specific membrane antigen (PSMA)-PET imaging in prostate cancer, announced Ariceum, the developer of the technology, in a news release.¹

""This technology simplifies the production of Ga-68 PSMA for the benefit of thousands of patients around the world, which is incredibly rewarding to see, says Greg Mullen, PhD.

The Ga-68 production kit will allow for multiple doses of Ga-68 HBED-PSMA-11 to be developed in a single vial via a 1-step process, which is an improvement on the multi-step approach that has been used to date. The patents apply exclusively to the Ga-68 HBED-PSMA-11 production kit (Locametz), developed by Advance Accelerator Applications. The IP was developed by Theragnostics Ltd, which Ariceum acquired earlier this year.

"This technology simplifies the production of Ga-68 PSMA for the benefit of thousands of patients around the world, which is incredibly rewarding to see. The granting of these patents represents another important milestone towards meeting anticipated increased demand for PSMA PET imaging of patients, following the publication of recent positive data demonstrating the benefit of radioligand therapy in prostate cancer,” said Greg Mullen, PhD, Chief Operating Officer of Ariceum Therapeutics and co-inventor of the patent, in the news release.¹

Mullen will present on radiopharmaceuticals during a presentation at the 5th Targeted Radiopharmaceuticals Summit Europe, held December 5-7, 2023 in Berlin, Germany. His presentation, “Understanding radionuclide Auger therapy to examine its use and advantages,” as well as a presentation from Chief Medical Officer of Ariceum Therapeutics Germo Gericke, MD, titled, “Bench to bedside – How to design innovative radiopharmaceuticals for human use,” will be presented on December 7.

Data on Ga-68

Gallium 68 PSMA-11 received FDA approval for PET imaging of PSMA-positive lesions in men with prostate cancer in December 2020.²

The approval was supported by data on the safety and efficacy of Ga-68 PSMA-11 in patients with prostate cancer, which was demonstrated in 2 prospective clinical trials that included a total of 960 men with prostate cancer who each received 1 injection of the agent.

In the first trial, 325 patients who were candidates for surgical removal of the prostate gland and pelvic lymph nodes and were considered at higher risk for metastasis underwent PET/CT or PET/MRI scans performed with Ga-68 PSMA-11. Of the patients who went on to undergo surgery, Ga-68 PSMA-11 PET demonstrated a clinically meaningful rate of metastatic cancer confirmed by surgical pathology in patients with positive readings in the pelvic lymph nodes.

The second trial included 635 patients who had rising serum PSA levels after initial prostate surgery or radiotherapy, of whom 74% had at least 1 positive lesion detected by Ga-68 PSMA-11 PET in at least 1 body region. In total, 91% of patients with positive Ga-68 PSMA-11 PET readings who had correlative tissue pathology from biopsies, who also had results from baseline or follow-up imaging by conventional methods, and serial PSA levels available for comparison, also had local recurrence or metastasis of prostate cancer confirmed.

No serious adverse events (AEs) were attributed to Ga-68 PSMA-11. The most common AEs included nausea, diarrhea, and dizziness.

References

1. Ariceum Therapeutics announces granting of US and Canadian patents for its Gallium-68 radiopharmaceutical production kit. News release. Ariceum Therapeutics. Published online and accessed December 6, 2023. https://www.prnewswire.com/news-releases/ariceum-therapeutics-announces-granting-of-us-and-canadian-patents-for-its-gallium-68-radiopharmaceutical-production-kit-302006798.html

2. FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer. News release. FDA. December 1, 2020. Accessed December 6, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-psma-targeted-pet-imaging-drug-men-prostate-cancer