31 October 2023

Oncoinvent Announces U.S. FDA Clearance of Investigational New Drug (IND) Application for Radspherin® in Ovarian Cancer Patients

Progressing to study Radspherin® in the first-line treatment setting for ovarian cancer
IND clearance is now obtained for both lead indications for Radspherin®


Oncoinvent AS, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for the phase 2 study for Radspherin® in patients with peritoneal carcinomatosis from ovarian cancer. This represents the second U.S. FDA IND clearance for Radspherin®, as last week, the company also announced an IND acceptance for Radspherin® in patients with peritoneal carcinomatosis from colorectal cancer.

“We are thrilled to announce the IND clearance for this phase 2b study of Radspherin®, allowing for inclusion of patients in the first-line treatment setting of ovarian cancer,” said Anders Månsson, Chief Executive Officer of Oncoinvent. “This IND clearance comes in succession to the IND clearance of Radspherin® in colorectal cancer patients, announced recently. With the initiation of two U.S. clinical trials, we look forward to broadening the clinical reach of Radspherin® to include both U.S. and Europe. With compelling data supporting Radspherin® from both clinical programs, we remain steadfast in our mission and eagerly anticipate moving forward to the next stages of development.”

In the phase 1 clinical trial of Radspherin® in recurrent ovarian cancer patients, a recommended dose of 7MBq was selected following the completion of dose escalation. Oncoinvent recently presented initial safety data from the ongoing RAD-18-001 study evaluating the dose, safety and tolerability of Radspherin® in patients with recurrent ovarian cancer at the 24th Congress of the European Society of Gynaecological Oncology (ESGO). The trial’s safety interim analysis demonstrated that Radspherin® was well tolerated with no dose-limiting toxicity observed.

The trial, for which we have now received U.S. FDA clearance, is planned to start in Q2 of 2024. It is a randomized controlled phase 2b trial, assessing efficacy and safety of Radspherin® in patients with peritoneal metastasis from ovarian cancer. The primary objective is to compare progression-free survival (PFS) between patients who receive Radspherin® after complete surgical resection following pre-operative chemotherapy and patients who only undergo pre-operative chemotherapy and surgery.


About Oncoinvent

Oncoinvent AS is a clinical stage company developing innovative radiopharmaceutical technology that delivers precise, alpha-emitting particles across solid cancers. By leveraging internal manufacturing and supply chain capabilities to enable a clinical supply of radioisotopes, the company is advancing a pipeline of novel products that use alpha particles, a higher Linear Energy Transfer (LET) form of radiation, that can potentially eradicate cancer cells. Oncoinvent’s lead candidate, Radspherin®, is designed for treatment of metastatic cancers in body cavities, and its versatility allows it to be deployed for the treatment of a variety of cancer indications. Radspherin® is in two ongoing clinical studies to treat peritoneal carcinomatosis from both ovarian cancer and colorectal cancer.


For further information, please contact:
Anders Månsson, Chief Executive Officer
Email: mansson@oncoinvent.com

Tore Kvam, Chief Financial Officer
Email: kvam@oncoinvent.com

IR enquiries:

Courtney Turiano, Stern Investor Relations
Email:  Courtney.Turiano@sternir.com


Anders Månsson

Chief Executive Officer


Anders Månsson is a business executive with over 25 years of experience from management roles in the pharmaceutical industry, focusing on commercialisation and M&A + licensing. Mr. Månsson has held leading roles in the industry both in his native Sweden and in other European countries, and he has worked extensively with the USA and Asia as focus markets in global roles.

Mr. Månsson holds a B.Sc. degree in Business & Economics from Lund’s University in Sweden as well as an MBA from Business School Lausanne in Switzerland. He has a broad-based industrial experience, featuring both large multinational companies such as Meda, Ferring & LEO Pharma, and including leading roles in start-ups and smaller biotech companies. On top of his executive role in Oncoinvent, Mr. Månsson holds two non-executive director positions serving on the board of EQL Pharma AB as well Immetric AB, the latter being an investment company focusing on life science.