Oncoinvent AS

OSLO, Norway, Oct. 10, 2024 /PRNewswire/ -- Oncoinvent, a clinical stage, radiopharmaceutical company developing innovative treatments for solid cancers, today announced that the first patient has been dosed in its Phase 2 study of Radspherin® in patients with peritoneal carcinomatosis from ovarian cancer. Radspherin® is a novel alpha-radiation therapy candidate designed for targeted, local treatment of cancers that have spread to body cavities. The Phase 2 trial is a randomized controlled study designed to assess progression-free survival (PFS) in primary advanced ovarian cancer patients treated with Radspherin® following complete surgical resection and pre-operative chemotherapy. "We are pleased to announce the dosing of the first patient in our Phase 2 study of Radspherin® in ovarian cancer patients, representing another pivotal achievement that underscores the potential of our clinical program," said Oystein Soug, Chief Executive Officer of Oncoinvent. "This milestone builds upon the highly encouraging data from our Phase 1/2a trials in ovarian and colorectal cancer patients, where Radspherin® demonstrated promising safety and efficacy. This follows the FDA's recently granted Fast Track designation, bringing us closer to demonstrating the therapeutic potential of Radspherin®. We look forward to advancing this clinical study as part of our mission to improve outcomes for patients suffering from peritoneal carcinomatosis." The Phase 2 trial (NCT06504147) is a randomized controlled study assessing the efficacy and safety of Radspherin® in patients with peritoneal metastasis from ovarian cancer. The primary objective is to compare PFS between patients who receive Radspherin® after complete surgical resection following pre-operative chemotherapy, and patients who only undergo pre-operative chemotherapy and surgery. The study is being conducted at six centers in the US, UK, Norway, Spain and Belgium. Positive Phase 1/2a data from the safety interim analysis demonstrated that Radspherin® was well tolerated with no dose-limiting toxicity observed at the recommended dose of 7MBq. About Oncoinvent Oncoinvent AS is a clinical stage, radiopharmaceutical company developing innovative treatments for solid cancers. The technology platform is focused on the use of alpha-emitting radionuclides to deliver powerful radiation directly to cancer cells. The Company's lead product candidate, Radspherin®, is being advanced through clinical development by a carefully composed team with experience from all stages of radiopharmaceutical development. Internal manufacturing and supply chain capabilities have been established, which now have the capacity to supply Radspherin® for multi-center phase 2 clinical studies. For additional information, please visit About Radspherin® Radspherin® is an investigational radiopharmaceutical designed for the local treatment of cancer that has spread to body cavities. It consists of billions of tiny calcium carbonate microparticles containing the radioactive material radium-224. The mode of action is the targeted delivery of alpha-particles, a highly potent form of radiation. Radspherin® is being investigated in ongoing clinical studies to treat peritoneal metastases from ovarian and colorectal cancer; it is administered intraperitoneally after surgical resection and removal of all macroscopic tumors. 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: Oystein Soug, Chief Executive Officer Email: [email protected] Tore Kvam, Chief Financial Officer Email: [email protected] IR enquiries: Courtney Mogerley, Precision AQ Email: [email protected] This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

A Phase IIb trial is assessing the safety and efficacy of the asset in patients with ovarian cancer-derived peritoneal metastases. Credit: Tattoboo/ Shutterstock. Oncoinvent has received fast-track designation from the US Food and Drug Administration (FDA) for its therapy, Radspherin, to treat peritoneal metastases from ovarian cancer. The process expedites the development and review of products targeting serious conditions with unmet medical needs, potentially enabling earlier patient access to new medicines. Fast-track status will offer Oncoinvent the advantage of more frequent interactions with the FDA throughout the clinical development of Radspherin. The designation makes it a candidate for accelerated approval and priority review. A lead candidate of the company, Radspherin is currently being evaluated in two active clinical studies for the treatment of peritoneal carcinomatosis resulting from both ovarian and colorectal cancer. See Also: Pharma M&A: The top high value deals in 2023 Medical packaging companies in pharmaceutical contract manufacturing An ongoing controlled, randomised Phase IIb clinical trial is assessing the safety and efficacy of Radspherin in patients with ovarian cancer-derived peritoneal metastases. The trial’s primary goal is to compare progression-free survival rates between patients receiving Radspherin post-surgical resection after pre-operative chemotherapy and those who receive the chemotherapy and surgery alone. Interim analysis from the Phase I/IIa safety study demonstrated promising results, with Radspherin offering a good tolerability profile. No dose-limiting toxicity was seen at the recommended 7MBq dose. Oncoinvent CEO Anders Månsson stated: “Fast track designation for Radspherin is a key milestone for Oncoinvent, particularly as we are on the verge of initiating a Phase IIb trial to evaluate Radspherin in peritoneal metastases from ovarian cancer, and later also in peritoneal metastases stemming from colorectal cancer 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.”

Phase 2b trial of Radspherin® to treat ovarian cancer patients expected to initiate imminently OSLO, Norway--(BUSINESS WIRE)-- Oncoinvent AS, 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.