Development of an alpha-emitting product for cancer treatment

Peritoneal carcinomatosis is one of the most serious complications of gastrointestinal and gynaecological malignancies. Oncoinvents lead product candidate, Radspherin®, is a new alpha-emitting radioactive microsphere designed for treatment of metastatic cancers in body cavities. Radspherin® has in animal models been shown to cause a reduction in tumour cell growth and a significant increased survival. It is anticipated that the product can potentially treat several forms of metastatic cancer. The first clinical indication for Radspherin® will be treatment of peritoneal carcinomatosis originating from ovarian cancer and colorectal cancer. A successful development of Radspherin® will present a novel treatment modality for a group of patients with poor prognosis. Radspherin® is composed of radioactive spheres for injection. The product is a suspension of inorganic microspheres labelled with an alpha-emitting radioisotope for regional administration. The therapeutic goal is to treat cancer metastasis of intracavitary surfaces and liquid volumes without harmful radiation doses to deeper regions of organs and tissues. The goal of the project has been to develop and test a prototype of Radspherin® in a clinical setting. Oncoinvent has since the initiation of the project in 2018 established a lab facility and a GMP approved production process of Radspherin®. Clinical studies of Radspherin® was initiated in 2020 in patients with peritoneal carcinomatosis at the Norwegian Radium Hospital, Oslo University Hospital, and the University Hospital in Leuven, Belgium (UZ Leuven). In the autumn 2021, the trial Safety Monitoring Committee approved the advancement of Radspherin® to the fourth and last dose level in ongoing phase 1 trial in ovarian cancer patients.

The end-goal of this innovation project is to provide improved treatment options for cancer patients with high medical needs. The project has by introducing Radspherin® a novel alpha-emitting cancer treatment to clinical trials been important to maintain and develop internationally leading key expertise in Oslo/Norway in the development of radiopharmaceuticals. The development of another alpha-emitting product in this industry will bolster the confidence in the capacity of this future oriented industry cluster and provide credibility to the ambition of building a robust healthcare industry in Norway. The project has created value for the principal investigator hospitals in gaining competence within the area for alpha-emitting radionuclides and their applicability in the treatment of cancers. Moreover, the knowledge developed during project will allow for further innovation within the field of internal radiation therapy, with potential to improve treatment options for cancer patient.

The goal of this project is to take Radspherin® to the next major value inflection point in its commercialization by demonstrating feasibility and safety in a clinical setting. The project includes research related to development of manufacturing and control procedures, pre-clinical studies and the first in human clinical study. A successful completion of the project will lead to further pivotal clinical studies, regulatory approval and commercial launch of Radspherin®. Peritoneal carcinomatosis (PC) is a collective term for the spreading of cancer into the abdominal cavity from primary cancers in surrounding organs (e.g. ovary, stomach, colon, liver). Current treatments for PC are inadequate and there is a great medical need for new treatments. Radspherin® is a novel therapeutic concept and has been designed for treatment of local metastatic cancer in body cavities. Radspherin® consists of an alpha-particle emitting radionuclide adsorbed to the surfaces of inorganic microparticle. Research results from pre-clinical studies indicate that the product candidate may be effective in treatment of peritoneal carcinomatosis. Peritoneal carcinomatosis in ovarian cancer patients have been chosen as the first target indication for Radspherin®. The partners of the project are Oncoinvent AS, two University Hospitals , Oslo University KU Leuven, Belgium, and a manufacturing partner - CPDC (The Centre for Probe Development and Commercialization) in Canada. Oncoinvent AS is the owner of the Radspherin® intellectual property rights. Oncoinvent will perform major parts of manufacturing and control procedures development, and preclinical testing. The two university hospitals have experience with treating OC patients with PC. These institutions are involved in the planning and conduct of both the pre-clinical and clinical research studies. CPDC, is a developer and commercial supplier of radioactive medical products.