Development of an alpha-emitting product for cancer treatment

Peritoneal karsinomatose er en av de mest alvorlige komplikasjonene til gastrointestinale og gynekologiske maligniteter. Oncoinvents ledende produktkandidat, Radspherin®, er en ny alfa-emitterende radioaktiv mikropartikkel, designet for behandling av metastaserende kreft i kroppshuler. Radspherin® har i dyremodeller vist seg å forårsake en reduksjon i tumorcellevekst og en betydelig økt overlevelse. Det er forventet at produktet potensielt kan behandle flere former for metastatisk kreft. Den første kliniske indikasjonen for Radspherin® vil være behandling av peritoneal karsinomatose som stammer fra eggstokkreft og tykktarmskreft. En vellykket utvikling av Radspherin® vil presentere en ny behandlingsmodalitet for en gruppe pasienter med dårlig prognose. Radspherin® består av radioaktive mikropartikler for injeksjon. Produktet er en suspensjon av uorganiske mikropartikler merket med en alfa-emitterende radioisotop for regional administrasjon. Det terapeutiske målet er å behandle kreftmetastaser av intrakavitære overflater og væskevolumer uten skadelige stråledoser til dypere områder av organer og vev. Målet med prosjektet har vært å utvikle og teste en prototype av Radspherin® for kliniske studier. Oncoinvent har siden starten av prosjektet i 2018 etablert et laboratorieanlegg og en GMP-godkjent produksjonsprosess av Radspherin®. Kliniske studier av Radspherin® ble igangsatt i 2020 hos pasienter med peritoneal karsinomatose ved Radiumhospitalet, Oslo Universitet Sykehus i Oslo og Universitet sykehuset i Leuven, Belgia (UZ Leuven). Høsten 2021 annonserte Oncoinvent at studiet Sikkerhetskomitéen godkjente at utprøving av Radspherin® kunne fortsette til fjerde og siste dosenivå i pågående fase 1-studie hos pasienter med eggstokkreft.

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.