Radspherin / Oncoinvent - LARVOL DELTA

First experience with intraperitoneal 224Ra-labeled microparticles after cytoreductive surgery in patients with peritoneal recurrence of platinum-sensitive epithelial ovarian cancer. (PubMed, Gynecol Oncol) - P1 | "All dose levels were well tolerated, with no DLT observed. The highest activity dose of 7 MBq was selected as recommended dose for an expansion cohort. No grade ≥ 3 adverse events related to Radspherin were reported."

Journal • Platinum sensitive • Epithelial Ovarian Cancer • Hematological Disorders • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Oncoinvent Reports Positive Final Data from Phase 1 Trial of Radspherin® to Treat Ovarian Cancer (Oncoinvent Press Release) - "In this Phase 1 trial, 10 out of 21 patients received the highest and recommended intraperitoneal dose of 7 MBq Radspherin after dose escalation (1, 2, 4 and 7 MBq).The final 24-month data still reports that only 1 of these 10 patients had peritoneal recurrence, and peritoneal recurrence rate remains at 10%. Two additional patients were reported with lymph node metastases outside of the peritoneum, giving an overall recurrence rate of 30%. In similar populations, approximately 55-60% of patients receiving best standard of care would expect disease recurrence at this time point."

P1 data • Platinum resistant • Ovarian Cancer • Peritoneal Cancer

Oncoinvent Presents Final Safety and Efficacy Results from the Phase 1/2a Trial of Radspherin to Treat Colorectal Cancer at the 15th PSOGI International Congress on Peritoneal Surface Malignancies (Oncoinvent Press Release) - "The final 18-month data reported that only 10 of these 36 patients (27.8 %) had peritoneal recurrence. Remarkably, only 2 out of the 36 patients experienced peritoneal metastases as the only site of disease recurrence. Further, at 18 months 61.1% (22 of 36) patients had experienced new metastases overall, giving a median disease-free survival of 13.5 months....The results strengthen the potential for Radspherin as a novel treatment option for patients with peritoneal metastases from colorectal cancer, demonstrating both clinical promise, as well as being well tolerated and safe to use..."

P1/2 data • Colorectal Cancer

Oncoinvent Reports Positive Final Data from Phase 1 Trial of Radspherin to Treat Ovarian Cancer (PRNewswire) - "The final 24-month data still reports that only 1 of these 10 patients had peritoneal recurrence, and peritoneal recurrence rate remains at 10%. Two additional patients were reported with lymph node metastases outside of the peritoneum, giving an overall recurrence rate of 30%....'We...look forward to interim results from our Phase 2 study next year'."

Clinical data • Platinum sensitive • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Peritoneal Cancer

Thor Medical ASA…and Oncoinvent ASA…have entered into a strategic agreement for Thorium-228 radioisotopes to supply the Phase 3 clinical program for Radspherin, Oncoinvent’s lead product candidate. (Oncoinvent Press Release)

Commercial • Ovarian Cancer

RAD-18-002: Study of Radspherin® in Colorectal Carcinoma Subjects With Peritoneal Carcinomatosis Treated With HIPEC (clinicaltrials.gov) - P1/2 | N=47 | Completed | Sponsor: Oncoinvent AS | Active, not recruiting ➔ Completed | Trial completion date: Feb 2025 ➔ May 2025 | Trial primary completion date: Feb 2025 ➔ May 2025

Trial completion • Trial completion date • Trial primary completion date • Colorectal Cancer • Oncology • Peritoneal Cancer • Solid Tumor

Oncoinvent…advancing Phase 2 program in ovarian cancer (Oncoinvent Press Release) - "Regulatory approvals for additional sites for the randomized Phase 2 trial in ovarian cancer, with expected onboarding before end of 2025."

Trial status • Ovarian Cancer

BerGenBio and Oncoinvent, a rising innovator in radiopharmaceutical cancer therapies, announce proposed merger and a fully underwritten rights issue (PRNewswire) - "BerGenBio ASA...and Oncoinvent ASA...announce that they have entered into a merger agreement (the 'Agreement') to combine the two companies through a statutory merger (the 'Merger'), where BerGenBio will be the acquiring entity....The Merger puts BerGenBio's capital and listing to productive use by strengthening Oncoinvent's ability to execute on its clinical strategy and advance potentially life-changing treatments for patients with cancer in the abdominal cavity (peritoneal carcinomatosis)....The merged company will carry out a fully underwritten rights issue of NOK 130 million (the 'Rights Issue'). The proceeds from the Rights Issue is expected to provide the merged company with a cash runway into 2027, beyond the interim readout from Oncoinvent's ongoing Phase 2 trial in ovarian cancer, expected H2 2026."

Financing • M&A • P2 data • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Peritoneal Cancer

Oncoinvent Announces Positive Final Data from Phase 1/2a Trial of Radspherin in Patients with Colorectal Peritoneal Metastases (Oncoinvent Press Release) - P1/2a | N=67 | RAD-18-002 (NCT03732781) | Sponsor: Oncoinvent AS | "Oncoinvent ASA...is thrilled to announce positive topline data from the Phase 1/2a clinical trial (RAD-18-002) evaluating Radspherin in patients with peritoneal metastases originating from colorectal cancer....Only 27.8%(10 of 36) experienced peritoneal disease recurrence at 18 months, a marked reduction compared to published data for standard of care, where approximately 50% of patients typically see peritoneal recurrence at this stage; At 18 months, 61.1%(22 of 36) of patients had experienced any recurrence, but notably, just 22.7% (5 of 22) had peritoneum as the first site of recurrence."

P1/2 data • Colorectal Cancer • Peritoneal Cancer

Oncoinvent (ONCIN): Invitation to Presentation of Positive Final Data from Phase 1/2a Trial of Radspherin in Patients with Colorectal Peritoneal Metastases (Oncoinvent Press Release) - "Oncoinvent ASA...invites for a presentation of the top-line results from the Phase 1/2a clinical trial (RAD-18-002) evaluating Radspherin in patients with peritoneal metastases originating from colorectal cancer."

P1/2 data • Colorectal Cancer

Oncoinvent Reports updated 18-Month Data from Phase 1 Ovarian Cancer Trial with Radspherin: No new recurrences Demonstrate Continued Promise of Preventing Disease Progression (PRNewswire) - P1 | N=49 | NCT03732768 | Sponsor: Oncoinvent AS | "Oncoinvent ASA...announced the 18-month follow-up results from its Phase 1 clinical trial (RAD-18-001) evaluating Radspherin in patients with platinum-sensitive recurrent ovarian cancer and peritoneal carcinomatosis....At the 18-month follow-up, no further patient had experienced recurrence. i.e., only 10% of patients treated have so far had a recurrence. In similar populations, receiving best standard of care, it is expected that approximately 40% of patients would have had disease recurrence at this time point."

P1 data • Platinum sensitive • Ovarian Cancer • Peritoneal Cancer

Oncoinvent ASA Announces Positive Safety Review of Lead-In Cohort, Advances to Randomised Part of Ongoing Phase 2 Trial of Radspherin in Ovarian Cancer Patients (Oncoinvent Press Release) - P2 | N=114 | NCT06504147 | Sponsor: Oncoinvent AS | "Oncoinvent...announced that the safety data from the patients in the safety lead-in cohort of its ongoing Phase 2 trial evaluating Radspherin for the treatment of peritoneal carcinomatosis from ovarian cancer has been reviewed by the company and study investigators. No safety concerns were identified, and based on this review, the company is pleased to confirm that the randomised part of the trial is now initiated, with the first patient successfully enrolled."

P2 data • Trial status • Ovarian Cancer • Peritoneal Cancer

Oncoinvent ASA announces oversubscribed private placement (PRNewswire) - "Oncoinvent ASA...is pleased to announce that it has today successfully completed the bookbuilding process for a private placement of new shares and that gross proceeds of NOK 130 million is being raised by the issuance of 65,000,000 new shares (the 'Offer Shares') at a subscription price of NOK 2 per share...'This funding will enable us to accelerate the development of Radspherin for patients with peritoneal carcinomatosis and create more value for our shareholders.'...The net proceeds from the Private Placement will be used to reach important Phase 1/2a clinical milestones in H2 2025, advancement of Phase 2 study in peritoneal metastases originating from ovarian cancer as well as for general corporate purposes."

Financing • Ovarian Cancer • Peritoneal Cancer

Oncoinvent Announces Promising Interim Results for Radspherin as a Potential Treatment for Peritoneal Carcinomatoses (Businesswire) - P1 | N=49 | NCT03732768 | Sponsor: Oncoinvent AS | "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."

P1 data • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Oncoinvent Announces Promising Interim Results for Radspherin as a Potential Treatment for Peritoneal Carcinomatoses (Businesswire) - P1/2a | N=67 | NCT03732781 | Sponsor: Oncoinvent AS | "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."

P1/2 data • Colorectal Cancer • Oncology • Peritoneal Cancer • Solid Tumor

Oncoinvent Announces Publication of 18-Month Safety and Efficacy Data from the Phase 1/2a Study of Radspherin in Colorectal Cancer (Businesswire) - P1/2a | N=67 | NCT03732781 | Sponsor: Oncoinvent AS | "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."

P1/2 data • Colorectal Cancer

Eighteen-Months Safety and Efficacy Following Intraperitoneal Treatment With 224Radium-Labeled Microparticles After CRS-HIPEC in Patients With Peritoneal Metastasis From Colorectal Cancer. (PubMed, J Surg Oncol) - "Radspherin was well tolerated. At 18 months, median disease-free survival has not been reached, and none of the patients receiving the recommended dose (7 MBq) had peritoneal recurrences. The results are encouraging and warrant further clinical evaluation."

Journal • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Peritoneal Cancer • Solid Tumor

Oncoinvent Announces First Patient Dosed in its Phase 2 Clinical Trial of Radspherin in Ovarian Cancer Patients (PRNewswire) - "Oncoinvent...announced that the first patient has been dosed in its Phase 2 study of Radspherin in patients with peritoneal carcinomatosis from ovarian cancer....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."

Trial status • Fallopian Tube Cancer • Ovarian Cancer • Peritoneal Cancer

A Study of Radspherin® in Patients With Primary Advanced Epithelial Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery (clinicaltrials.gov) - P2 | N=114 | Recruiting | Sponsor: Oncoinvent AS

Metastases • New P2 trial • Surgery • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Oncoinvent Receives FDA Fast Track Designation for Radspherin as Treatment for Peritoneal Carcinomatosis from Ovarian Cancer (Businesswire) - "Oncoinvent AS...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'....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 • New P2b trial • Colorectal Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Study of Radspherin® in Recurrent Ovarian Cancer Subjects With Peritoneal Carcinomatosis (clinicaltrials.gov) - P1 | N=49 | Active, not recruiting | Sponsor: Oncoinvent AS | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Study of Radspherin® in Colorectal Carcinoma Subjects With Peritoneal Carcinomatosis Treated With HIPEC (clinicaltrials.gov) - P1/2 | N=67 | Active, not recruiting | Sponsor: Oncoinvent AS | Recruiting ➔ Active, not recruiting

Enrollment closed • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Peritoneal Cancer • Solid Tumor

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

IND • New P2b trial • Ovarian Cancer • Peritoneal Cancer

Oncoinvent Announces U.S. FDA Clearance of Investigational New Drug (IND) Application for Radspherin in Colorectal Cancer Patients (Businesswire) - "Oncoinvent AS...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 2b study for Radspherin in patients with peritoneal carcinomatosis from colorectal cancer....The planned trial, for which we have now received FDA clearance, is a randomized controlled phase 2b trial, assessing efficacy and safety of Radspherin in patients with peritoneal carcinomatosis from colorectal carcinoma following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The primary objective for the trial, planned to start in Q2 of 2024, is to compare progression-free survival (PFS) between patients following CRS and HIPEC and Radspherin versus CRS and HIPEC."

IND • New P2b trial • Colorectal Cancer

Oncoinvent To Present Initial Safety Data from the Phase 1 Trial of Radspherin in Ovarian Cancer Patients at the 24th Congress of the European Society of Gynaecological Oncology (ESGO) (Businesswire) - P1 | N=49 | NCT03732768 | Sponsor: Oncoinvent AS | "The ongoing Phase 1 study is designed to evaluate the recommended dose, safety and tolerability of Radspherin® injected intraperitoneally following secondary cytoreductive surgery. The safety interim analysis after completion of the dose-limiting toxicity (DLT) period demonstrated that Radspherin® was well tolerated. The highest dose of 7 MBq was recommended following the completion of dose escalation of 1-2-4-7 MBq, as no DLT was observed."

P1 data • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor