Radspherin

OSLO, Norway--( BUSINESS WIRE )--Oncoinvent ASA, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, today announced an interim data readout of the Phase 1/2a studies of Radspherin® for the treatment of peritoneal carcinomatoses. The studies were closed for recruitment at the end of 2023, and patients are currently in long-term follow-up. The readout confirmed the previously published results on efficacy and adds further confidence in the ongoing randomized controlled Phase 2 clinical trial for Radspherin® in patients with ovarian cancer. In the first interim readout from the Phase 1 study in ovarian cancer, only 1 patient out of the 10 receiving the selected dose (10%) had peritoneal recurrence at the 12-month interim readout, compared to an expected recurrence rate of 25% in similar populations [1-3]. Correspondingly, in the second intermediate readout of the colorectal cancer study, only 3 of 20 patients (15%) receiving the selected dose of 7 MBq had peritoneal recurrence after the full 18 months follow-up period. With current standard therapy, the expected peritoneal recurrence rate is approximately 50% after 18 months [4]. 36 patients with colorectal cancer have received the selected dose, with results from the final 16 patients still pending full follow-up. “We are excited to announce the interim results of our Phase1/2a studies of Radspherin®, confirming a positive efficacy signal and demonstrating Radspherin’s® ability to enable local control in the peritoneum, thus ensuring patients remain in remission after surgery,” said Oystein Soug, Chief Executive Officer of Oncoinvent. “These positive results increase confidence in the further development of Radspherin® as an effective treatment option for patients suffering from peritoneal carcinomatoses, a condition that is notoriously difficult to treat effectively with systemic therapy.” “Patients with ovarian cancer often have peritoneal carcinomatoses already at diagnosis, giving them higher recurrence rate and worse prognosis - so an effective treatment targeted specifically at these carcinomatoses could reduce recurrence and prolong survival,” says Yun Wang, MD PhD, Department of Gynecologic Oncology, The Norwegian Radium Hospital, Oslo University Hospital, principal investigator in the RAD-18-001 study. 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 calcium carbonate microparticles containing the radioactive material radium-224. The mode of action is the decay of radium-224 emitting alpha-particles, a highly potent form of ionizing radiation. Radspherin® is investigated in ongoing clinical studies to treat peritoneal carcinomatoses from ovarian and colorectal cancer and it is administered intraperitoneally after surgical resection with removal of all macroscopic tumors. About the RAD-18-001 and RAD-18-002 study Two early phase studies with Radspherin® in patients with peritoneal carcinomatoses have completed recruitment at the end of 2023 with 68 patients treated. One study in patients with peritoneal carcinomatoses from platinum sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma (RAD-18-001, n=21, phase 1) scheduled for secondary cytoreduction, and one in patients with peritoneal carcinomatoses from colorectal cancer (RAD-18-002, n=47, phase 1/2a) scheduled for cytoreduction and HIPEC. The two studies were designed to evaluate the dose, safety and tolerability, dosimetry, and signal of efficacy of Radspherin®. About Oncoinvent Oncoinvent ASA 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 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. 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. References [1] Coleman, R. L., Spirtos, N. M., Enserro, D., Herzog, T. J., Sabbatini, P., Armstrong, D. K., ... & Mannel, R. S. (2019). Secondary surgical cytoreduction for recurrent ovarian cancer. New England Journal of Medicine , 381 (20), 1929-1939. [2] Harter, P., Sehouli, J., Vergote, I., Ferron, G., Reuss, A., Meier, W., ... & Du Bois, A. (2021). Randomized trial of cytoreductive surgery for relapsed ovarian cancer. New England Journal of Medicine , 385 (23), 2123-2131. [3] Shi, T., Zhu, J., Feng, Y., Tu, D., Zhang, Y., Zhang, P., ... & Zang, R. (2021). Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): a multicentre, open-label, randomised, phase 3 trial. The Lancet Oncology , 22 (4), 439-449. [4] Quénet, F., Elias, D., Roca, L., Goéré, D., Ghouti, L., Pocard, M., ... & Patrick, R. A. T. (2021). Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy versus cytoreductive surgery alone for colorectal peritoneal metastases (PRODIGE 7): a multicentre, randomised, open-label, phase 3 trial. The Lancet Oncology , 22 (2), 256-266.

OSLO, Norway--( BUSINESS WIRE )--Oncoinvent AS, a clinical stage company advancing alpha emitter therapy across a variety of solid cancers, today announced the publication of data from the Phase 1/2a study of Radspherin® in colorectal cancer patients in the peer-reviewed Journal of Surgical Oncology . The results, previously presented at the 2023 Peritoneal Surface Oncology Group International (PSOGI) Congress in Venice, show encouraging 18 months safety and efficacy data from the 23 patients enrolled in the Phase 1 part of the RAD-18-002 study in colorectal cancer patients. “We are pleased to see our data published in such a well-recognized scientific journal,” commented Professor Emeritus Oyvind Bruland, MD, PhD, senior author on the manuscript, co-founder and member of Oncoinvent’s scientific advisory board. "The data in the publication highlights the potential of Radspherin® in treating patients with peritoneal metastases from colorectal cancer, a condition for which there is an urgent unmet need for novel treatment options." “Patients with liver and lung metastases benefit considerably from several other new treatment options, but not those with peritoneal metastases,” commented Stein G. Larsen, MD, PhD, principal investigator of the study and chief gastrosurgeon, the Norwegian Radium Hospital, Oslo University Hospital. The publication concludes that Radspherin® was well tolerated following cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). At 18 months, none of the patients receiving the recommended dose (7 MBq) had peritoneal recurrences. Radspherin® also showed a promising signal of efficacy warranting further clinical evaluation. Results from 24 more patients treated with Radspherin® in the RAD-18-002 study are pending. The Journal of Surgical Oncology publication is available online at: https://onlinelibrary.wiley.com/doi/full/10.1002/jso.27897 About the RAD-18-002 Study RAD-18-002 is a Phase 1/2a open-label study designed to select the clinical dose, and evaluate the safety, tolerability, and signal of efficacy of intraperitoneally administered Radspherin® in patients with peritoneal metastases from colorectal cancer scheduled for cytoreduction and HIPEC. The study was closed for recruitment at the end of 2023. 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 calcium carbonate microparticles containing the radioactive material radium-224. The mode of action is the decay of radium-224 emitting alpha-particles, a highly potent form of ionizing radiation. Radspherin® is investigated in ongoing clinical studies to treat peritoneal metastases from ovarian and colorectal cancer and it is administered intraperitoneally after surgical resection with removal of all macroscopic tumors. 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 www.oncoinvent.com . 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.