In February 2023, Beforpharma and University of Bari received national patent (with international extension) for a technology of cold kit based on PSMA ligands for the preparation of radiopharmaceutical, in particular 68Ga-PSMA-11. The invention was developed by group of researchers from University of Bari, Department of Pharmacy and Beforpharma. 68Ga-PSMA-11 radiopharmaceutical is used to conduct PET-CT imaging in patients suspected or suffering from prostate cancer.
68Ga-PSMA-11 radiopharmaceutical is an effective screening tool for detecting localization of prostate cancer cells. In recent years, Gallium-68-PSMA PET/CT demonstrated outstanding diagnostic performance worldwide. The doses are produced in hospital radiopharmacies individually for each patient at the day of PET-imaging procedure. It’s prepared mostly by means of manual or automated synthesis modules, while a sterile cold kit based preparation has been recently introduced to clinical practice. To ensure safety and high quality of doses for injection to patients, cold kit labeling of 68Ga-PSMA-11 radiopharmaceutical adheres to the current Good Manufacturing Practice (cGMP) and European Pharmacopeia.
‘The radiopharmaceutical is injected intravenously and helps diagnose prostate cancer because it is localized at the level of the tumor, highlighting it. The clinical trial phase has been already planned’ explains Nunzio Denora, Professor in Pharmaceutical Technology at the Department of Pharmacy – Pharmaceutical Sciences of the University of Bari.
University of Bari and Beforpharma srl started research and development of the product in 2017. In 2020, Beforpharma srl applied for a national patent. In December 2021, the company requested international extension of its application. Early 2023, the patent was finally granted.
‘The drug can help to overcome some current limits in the radiopharmaceutical sector – says Dr. La Forgia – To use it, a single procedure is enough, it can be kept at room temperature and has a pH that is completely compatible with that of the patients’ concludes CEO of Beforpharma.
The invention describes a novel formulation, based on Prostate-Specific Membrane Antigen (PSMA) ligands, for use as radiopharmaceutical cold kits. The formulation of the invention is designed to allow the radiopharmaceutical to be prepared instantaneously and in a single step by direct addition of radioactive isotopes, to be used both for diagnostic and therapeutic purposes. The advantages of Apulian invention are: simplified production process allowing to produce cold kit without synthesis module that is quite expensive equipment; cold kit can be stored at room temperature; preparation of radiopharmaceutical with a cold kit can reduce expenses of nuclear medicine department.
‘68Ga-PSMA-11 is a radiopharmaceutical agent that continuously broadens its application in PET imaging. We believe that new ‘made in Italy’ technology of 68Ga-PSMA-11 cold kit is able to increase access to innovative imaging technologies not only in Italy but also abroad. At the moment, we are searching for a contract manufacturing partner to develop production part” explains Dr. Maria De Bari, Chief Operating Officer at Beforpharma.
68Ga-PSMA-11 was discovered more than 10 years ago. In 2020, alternative technology of 68Ga-PSMA-11 cold kit has been approved in the USA by the Food and Drug Administration (FDA) as the first 68Ga-radiopharmaceutical for the PET imaging of PSMA-positive prostate cancer. Currently, in Europe there is no 68Ga-PSMA-11, obtained Marketing Authorization. This factor accelerates ‘in-house’ hospital preparations of 68Ga-PSMA-11 radiopharmaceuticals.
Every year in Italy about 40,000 men are diagnosed with prostate cancer, total number of prostate cancer cases in Italy is 564,000, according to the report Number of Cancer in Italy 2022. Early cancer diagnosis ensures prompt treatment, enabling more therapeutic tools, as well as reduces cancer’s financial impact. PET/CT, using radioactive tracer, is a highly sensitive imaging technique capable to identify signs of cancer, heart diseases or brain disorders.