Oncoinvent Receives FDA Fast Track Designation for Radspherin® as Treatment for Peritoneal Carcinomatosis from Ovarian Cancer
Phase 2b trial of Radspherin® to treat ovarian cancer patients expected to initiate imminently
Oslo, Norway 24, June 2024
Oncoinvent ASA, a clinical stage radiopharmaceutical company advancing alpha emitter therapy
across a variety of peritoneal metastases, today announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation to Radspherin® for the treatment of patients with peritoneal metastases from ovarian cancer.
“Fast Track designation for Radspherin® is a key milestone for Oncoinvent, particularly as we are on
the verge of initiating a Phase 2b trial to evaluate Radspherin® in peritoneal metastases from ovarian
cancer, and later also in peritoneal metastases stemming from colorectal cancer patients,” said Anders Månsson, Chief Executive Officer of Oncoinvent. “Importantly, this designation reinforces the urgent need for safe and effective therapies for patients suffering from peritoneal metastases. These
metastases have a particularly negative impact on life expectancy and effective treatment therefore
has a significant chance of affecting overall survival in these patients. We believe we are well
positioned to execute the clinical development of Radspherin® in our upcoming trial and look forward to advancing this innovative product candidate to benefit patients battling this type of cancer, for whom there are limited treatment options.”
The randomized, controlled Phase 2b trial will assess the efficacy and safety of Radspherin® in
patients with peritoneal metastases 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. Positive data from the Phase 1/2a safety interim analysis demonstrated
that Radspherin® was well tolerated with no dose-limiting toxicity observed with the administration
of the recommended dose of 7MBq.
Fast Track designation is a process that is designed to facilitate the development and expedite the
review of therapies intended to treat serious conditions and address unmet medical needs to
potentially bring important new medicines to patients earlier. Companies whose programs are
granted Fast Track designation are eligible for more frequent interactions with the FDA during clinical development. Provided relevant criteria are met, programs with Fast Track designation are eligible for accelerated approval and priority review as well.
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 have been shown to eliminate 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.
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Oncoinvent’s plans, estimates, or expectations
will be achieved. These forward-looking statements represent Oncoinvent’s expectations as of the
date of this press release, and Oncoinvent disclaims any obligation to update the forward-looking
statements. These forward-looking statements are subject to known and unknown risks and
uncertainties that may cause actual results to differ materially, including with respect to whether the
results of clinical or other studies will support the use of our product offerings, the impact of results
of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the
benefits of our tests and product offerings to patients, providers and payers.
For further information, please contact:
Anders Månsson, Chief Executive Officer
Email: [email protected]
Tore Kvam, Chief Financial Officer
Email: [email protected]
IR enquiries:
Courtney Mogerley, Precision AQ
Email: [email protected]