University of Navarra

OSLO, Norway, April 28, 2025 /PRNewswire/ -- Oncoinvent ASA, a clinical-stage radiopharmaceutical company developing innovative treatments for solid cancers, today 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. The trial was closed for recruitment at the end of 2023 and patients are currently in long-term follow-up. In this trial, 10 patients received a single intraperitoneal dose of 7 MBq Radspherin®. Oncoinvent reported 12-month data in November 2024, where only 1 out of the 10 receiving the selected dose had peritoneal recurrence. 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[1],[2],[3]. "Ovarian cancer's characteristic peritoneal metastasis lead to frequent recurrences despite a comprehensive treatment approach," commented Dr. Luis Chiva, Principal Investigator and Director of Department of Obstetrics and Gynecology, Clinica Universidad de Navarra, Spain. "I am proud to be part of a study program exploring whether Radspherin® may become a novel therapy that can prevent disease progression, offering hope for a better and longer life for my patients." "These compelling results underscore Radspherin®'s potential to significantly reduce peritoneal recurrence in ovarian cancer patients," said Øystein Soug, CEO of Oncoinvent. "The data not only reinforce our confidence in Radspherin® but also support its advancement in Phase 2 trials, including the ongoing randomized controlled Phase 2 trial assessing progression-free survival in patients with peritoneal metastasis from ovarian cancer." To discuss these promising clinical results, provide an update on operations, and discuss the ongoing Phase 2 trial, Oncoinvent has decided to move up its Quarterly Update from the previously announced May 27 to April 30 at 11:00 CEST. About Oncoinvent Oncoinvent is a clinical-stage biotechnology company developing novel radiopharmaceutical therapies against cancer. The lead product candidate, Radspherin®, uses the alpha-emitting radionuclide radium-224, directly targeting micro-metastases post-surgery, harnessing the benefits of modern radiopharmaceuticals without the complexities of biological targeting. Oncoinvent is investigating the safety and efficacy of Radspherin® in a clinical development program in two indications. Currently one Phase 1 trial, one Phase 1/2a trial and one randomized Phase 2 trial are ongoing in the US, UK and Europe. Preliminary clinical efficacy data are highly encouraging, and no serious toxicity or safety concerns have been reported to date. The Oncoinvent team consists of approx. 30 employees and runs a state-of-the-art manufacturing facility to produce drug products for clinical trials in Nydalen, Oslo. Oncoinvent is listed on the Euronext Growth Oslo. 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. 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: Øystein Soug, Chief Executive Officer Email: [email protected] Tore Kvam, Chief Financial Officer Email: [email protected] [1] Coleman et al. N Engl J Med. 2019 Nov 14;381(20):1929-1939 [2]Harter et al. N Engl J Med. 2021 Dec 2;385(23):2123-2131 [3] Shi et al. Lancet Oncol. 2021 Apr;22(4):439-449 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

Among 84 patients evenly split in each study arm, HexaBody-CD38 elicited an objective response rate of 55% compared to 52% in the Darzalex arm.\n Johnson & Johnson is dropping a partnership with Genmab centered around a CD38 monoclonal antibody, prompting the latter company to discontinue development of the program.Back in 2019, the companies teamed up to develop a successor to their multiple myeloma blockbuster Darzalex, an anti-CD38 antibody. The deal gave J&J the option to license HexaBody-CD38—which was designed using Genmab tech that aims to dial up the cancer-killing power of therapeutics—after a proof-of-concept study for $150 million, plus potential milestones and royalties. Now, the Big Pharma has determined that it won’t exercise that option, according to a March 10 release. Furthermore, Genmab has decided that it won’t continue development of the monoclonal antibody.Genmab credited the discontinuation to a “thorough evaluation of the data, the market landscape and Genmab’s rigorous portfolio prioritization.”In 2020, Sanofi\'s Sarclisa (isatuximab-irfc), a CD38-directed cytolytic antibody, snared FDA approval to treat patients with relapsed or refractory multiple myeloma. Since then, the FDA has also granted the immunotherapy approval for newly treated myeloma. Under the terms of Genmab\'s agreement with J&J, the Danish company provided data from a clinical proof-of-concept study in multiple myeloma, including a head-to-head comparison with Darzalex (daratumumab).The phase 2 expansion part of the trial assessed the objective response rate (ORR) of intravenous HexaBody-CD38 versus subcutaneous daratumumab in patients with anti-CD38 antibody-naïve relapsed or refractory multiple myeloma.Among 84 patients evenly split in each arm, HexaBody-CD38 elicited an ORR of 55% compared to 52% in the daratumumab arm.The complete response rate was 7% for HexaBody-CD38 and 2% for daratumumab.Duration of response, progression-free survival and overall survival were not yet reached at the time of data cutoff. Genmab expects to share more mature data at a future medical conference. Treatment-emergent adverse events affecting more than 20% of patients in the HexaBody-CD38 arm were neutropenia, infusion-related reactions, anemia and thrombocytopenia. One patient died from a TEAE in the HexaBody-CD38 arm, while two patients died in the daratumumab arm; the three deaths were not related to the study treatment, according to Genmab.  “While we are disappointed that J&J has decided not to advance HexaBody-CD38, the data confirms the clinical potential of the HexaBody platform, reinforcing its value for future applications,” Genmab CEO Jan van de Winkel, Ph.D., said in the release.The leader instead pointed to later-stage opportunities in Genmab’s pipeline, such as rinatabart sesutecan (Rina-S)—a potential challenger to AbbVie’s Elahere that Genmab gained in its $1.8 billion ProfoundBio buyout—and PD-L1x4-1BB bispecific antibody acasunlimab. Both assets are currently undergoing phase 3 testing.   The pipeline discontinuation and J&J’s decision not to take up the option for HexaBody-CD38 do not impact Genmab’s 2025 financial guidance, according to the company. Analysts at William Blair called the opt-out \"unfortunate but largely expected\" in a March 10 note, adding that \"getting past the highly anticipated JNJ decision and expected share pullback now allows investors to focus on the company’s pipeline and potential blockbusters including Epkinly, Rina-S and acasunlimab.\"Since the company’s announcement, which was made around 10 a.m. ET, Genmab’s stock has dropped more than 8% from its market open price of $23.93 per share, settling at $21.98 as of 4 p.m. ET on March 10.Editor\'s note: This story was updated at 5:30 p.m. ET on March 10 to include analysis from William Blair.

THURSDAY, Feb. 27, 2025 -- Higher adherence to the Mediterranean diet (MedDiet) is associated with a modest reduction in the risk for obesity-related cancers (ORCs), according to a study published online Feb. 25 in JAMA Network Open . Inmaculada Aguilera-Buenosvinos, Ph.D., from the University of Navarra in Spain, and colleagues examined the association between adherence to the MedDiet and the risk for ORCs. The analysis included data from 450,111 participants (mean age, 51.1 years) in the European Prospective Investigation Into Cancer and Nutrition study. The researchers found that during a median 14.9 years of follow-up, 4.9 percent of participants experienced an ORC (rates, 0.053, 0.049, and 0.043 per person-year in the low, medium, and high MedDiet adherence groups, respectively). Compared with low MedDiet adherence (0 to 3 points), participants with high adherence to the MedDiet (7 to 9 points) had a lower risk for ORC (hazard ratio, 0.94). A similar inverse association was seen for participants with medium adherence (4 to 6 points) compared with low adherence. "Our mediation analysis did not show waist-to-hip ratio or body mass index as mediators between MedDiet and ORC risk, possibly due to the low prevalence of obesity in our cohort and the distinct contribution of general versus abdominal obesity to metabolic disruptions," the authors write. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.