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

On October 31, 2023 Oncoinvent AS, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, reported 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 (Press release, Oncoinvent, OCT 31, 2023, View Source [SID1234636591]). 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.

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"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.