AOP-HEALTH
10.6.2024 13:15:26 CEST | Business Wire | Press release
AOP Orphan Pharmaceuticals GmbH (AOP Health) continues a successful clinical research program in hematology/oncology with two abstracts accepted for presentation at the European Hematology Association (EHA) 2024 hybrid congress in Madrid, Spain. One results in an oral presentation of the latest results from the PROUD-PV and CONTINUATION-PV-trials. The outcomes show a correlation between the changes at genetic level (molecular response) and event-free survival (EFS) among patients with a rare blood cancer (polycythemia vera /PV) who received a certain interferon (ropeginterferon alfa-2b/BESREMi®) or best available treatment.1 A second accepted abstract reports on AOP Health’s recently initiated phase III clinical study extending investigation of ropeginterferon alfa-2b to patients with another rare blood cancer, essential thrombocythemia (ET).2 In a further signal of AOP Health’s commitment to innovative research, early development of a first-in-class investigative oncology drug is progressing towards clinical trials.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240610730599/en/
Professor Jean-Jacques Kiladjian, University of Paris, France Photo credit: AOP Health/Lorenz Paulus
Reduction of mutated cells improves event free survival in patients with PV and is effectively achieved by ropeginterferon alfa-2b
The latest findings of the large randomized controlled PROUD-PV trial and its extension CONTINUATION-PV3 showed that ropeginterferon alfa-2b reduced the amount of cells that carried a mutation of a certain gene (JAK2V617F, a gene, which regulates cellular growth) in the patient population studied.3 Analysis of all patients included in the trial over at least 6 years showed significantly prolonged event free survival (period in which patients remain free from events that the treatment was intended to prevent or delay) among patients in which the amount of mutated cells were reduced at the last available assessment.
Professor Jean-Jacques Kiladjian from the University of Paris, France and first author of the paper emphasizes: “This new evidence supports the clinical relevance of reducing the load resulting of JAK2V617F mutations to improve long-term outcomes in patients with PV, which should be considered as an aim of treatment. Ropeginterferon alfa-2b targets mutated blood-forming stem cells and is highly effective in decreasing the burden resulting from the mutation of JAK2V617F gene.”
Phase III clinical study of ropeginterferon alfa-2b in ET underway in Europe
With the aim of examining the potential utility of ropeginterferon alfa-2b in ET patients with significant unmet need, AOP Health has rolled out the ROP-ET trial, a prospective, multicenter, single-arm phase III study to assess the long-term safety and efficacy of ropeginterferon alfa-2b in ET patients unable to receive available cytoreductive therapies.4 The trial is being conducted at 36 sites in 10 countries in Europe. Almost 50 % of the required number of patients have already been enrolled in the study. This fast recruitment underlines the importance of the clinical trial.
New drug candidate: official start of clinical development imminent
Building on proven success in the development of cancer stem cell targeting therapies, AOP Health is expanding into a new area of research with a first-in-class investigational oncology drug candidate. This orally available, highly selective serotonin receptor 1B antagonist was discovered and initially developed by Leukos Biotech based on research performed at the Josep-Carreras Leukemia Research Institute and licensed by AOP Health for further development and commercial rights. SERONCO-1, a phase I, first-in-human trial in patients with solid tumors and lymphomas will be conducted in collaboration with Leukos Biotech at the Vall d’Hebron Institute of Oncology (VHIO) with partial funding from the Spanish Ministry of Science and Innovation through the Public-Private Partnership Program (CPP2021-008715). A subsequent trial in acute myeloid leukemia is expected to commence in 2026.
References
- Kiladjian J-J, Klade C, Georgiev P, et al. JAK2V617F MOLECULAR RESPONSE CORRELATES WITH EVENT-FREE SURVIVAL IN AN EARLY POLYCYTHEMIA VERA POPULATION. 2024. https://library.ehaweb.org/eha/2024/eha2024-congress/422323 Last accessed 27 May 2024.
- Kiladjian J-J, Ferrer Marín F, Al-Ali FK et al. ROP-ET: A PROSPECTIVE PHASE III TRIAL INVESTIGATING THE EFFICACY AND SAFETY OF ROPEGINTERFERON ALFA-2B IN ESSENTIAL THROMBOCYTHEMIA PATIENTS WITH LIMITED TREATMENT OPTIONS. 2024. https://library.ehaweb.org/eha/2024/eha2024-congress/421616. Last accessed 27 May 2024.
- Gisslinger H, Klade C, Georgiev P, et al. Event-free survival in patients with polycythemia vera treated with ropeginterferon alfa-2b versus best available treatment. Leukemia. 2023 Oct;37(10):2129-32.
- Kiladjian JJ, Marin FF, Al-Ali HK, et al. ROP-ET: a prospective phase III trial investigating the efficacy and safety of ropeginterferon alfa-2b in essential thrombocythemia patients with limited treatment options. Annals of Hematology. 2024 Mar 4:1-2.
About BESREMi®
BESREMi® is a long-acting, mono-pegylated proline interferon (ATC L03AB15). Its unique pharmacokinetic properties offer a new level of tolerability. BESREMi® is designed to be conveniently self-administered subcutaneously with a pen once every two weeks, or up to monthly after stabilization of hematological parameters. This treatment schedule is expected to lead to overall better safety, tolerability and adherence compared to conventional pegylated interferons.
Approximately 7800 patients are currently treated or have been treated with BESREMi®.
For the EMA Summary of Product Characteristics please visit: BESREMi®
Link: https://www.ema.europa.eu/en/documents/product-information/besremi-epar-product-information_en.pdf
Ropeginterferon alfa-2b was discovered by PharmaEssentia, a long-term partner of AOP Health. In 2009, AOP Health in-licensed the exclusive rights for clinical development and commercialization of Ropeginterferon alfa-2b in PV and other MPNs such as chronic myelogenous leukemia (CML) for European, Commonwealth of Independent States (CIS), and Middle Eastern markets.
About AOP Health
The AOP Health Group incorporates several companies including AOP Orphan Pharmaceuticals GmbH with its seat in Vienna, Austria (“AOP Health”). The AOP Health Group is the European pioneer for integrated therapies for rare diseases and in critical care. Over the past 25 years, the Group has become an established provider of integrated therapy solutions operating from its headquarters in Vienna, its subsidiaries and representative offices throughout Europe and the Middle East, as well as through partners worldwide. This development has been made possible by a continually high level of investment in research and development on the one hand and a highly consistent and pragmatic orientation towards the needs of all its stakeholders on the other – especially the patients and their families as well as also the healthcare professionals treating them.
Needs. Science. Trust.
AOP Orphan Pharmaceuticals GmbH
Member of the AOP Health Group
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240610730599/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
SES and Air Astana Introduce Multi-orbit Inflight Connectivity on A321LR Fleet30.10.2026 18:35:00 CET | Press release
First aircraft is now delivering a new generation of onboard Wi-Fi experiences for business and leisure travelers SES was selected by Air Astana, the award-winning flag carrier of Kazakhstan, to introduce next-generation inflight connectivity services across its Airbus A321LR fleet. The first connected aircraft entered commercial service on 29 October 2026. Fleet-wide deployment will continue across the remaining A321LR fleet. Equipped with SES’s new electronically steered array (ESA) antenna, the aircraft delivers reliable connectivity over the SES multi-orbit network. SES will provide a fully managed inflight connectivity service across the fleet, enabling Air Astana passengers to enjoy a seamless online experience throughout their journey. “Airlines are increasingly looking for connectivity solutions that deliver a seamless passenger experience while providing the flexibility to evolve with changing customer expectations,” said Blane Boynton, Senior Vice President, Aviation at SES.
CIRCOR to Expand Industrial Portfolio with Acquisition of Green Silence Group S.p.A.30.10.2026 17:06:00 CET | Press release
Acquisition adds complementary pump, electric motor and control technologies to strengthen CIRCOR's industrial solutions portfolio CIRCOR, a KKR portfolio company and global manufacturer of flow control products for industrial and naval markets, today announced that it has signed a definitive agreement to acquire Green Silence Group S.p.A., an Italian provider of hydraulic pumps, electric motors and advanced engineering solutions. The acquisition will bring together the complementary capabilities of Settima, Motive and Spin expanding CIRCOR’s Industrial portfolio with three-screw and ultra-low-noise hydraulic pumps, Motive electric motors, high-efficiency rare-earth-free motor technologies, power electronics and advanced engineering capabilities. Together, these technologies will broaden CIRCOR’s ability to deliver integrated solutions that improve system efficiency, reduce energy consumption and critical raw materials dependency, and address evolving customer needs across industrial a
QuectelSues Telit, Alleging False Statements, Cybersquatting and Unfair Competition30.10.2026 16:41:00 CET | Press release
Quectel Wireless Solutions, a global end-to-end IoT solutions provider, today announced that it has filed legal action in the United States District Court for the Southern District of Florida against Telit IoT Solutions Inc. The lawsuit seeks to bring an end to Telit’s campaign of false and misleading claims about Quectel and its products. Quectel alleges that, rather than competing on the strength of its products and technology, Telit engaged in a coordinated campaign to undermine Quectel’s reputation by exploiting geopolitical concerns surrounding Chinese technology companies. According to the complaint, Telit funded, promoted, and amplified false and misleading claims about Quectel’s products while positioning itself to customers as a safer “Western” alternative. The lawsuit further alleges that Telit engaged in cybersquatting involving Quectel’s U.S. domain name to advance its campaign. Quectel maintains that these alleged actions have caused substantial harm to its sales, customer
TestMu AI Launches Kane CLI Exploration, an AI Agent That Maps an Entire Web App From a Single URL and Turns It Into Tests30.10.2026 15:00:00 CET | Press release
The exploration agent walks every page and flow of a web app on its own, flags UX, security and accessibility issues, and builds the map Kane CLI uses to write, run and ship tests to CI, even when no requirements exist TestMu AI, the Full Stack Agentic AI Quality Engineering platform, announced Kane CLI Exploration, an autonomous agent that learns a web application before anyone writes a test. Given a single URL, it walks the entire app on its own, flags problems along the way and gives Kane CLI the context it needs to generate and run tests, even when no requirements, user stories or acceptance criteria exist. Every test plan starts from something written down, and many apps never had it. Legacy products lose their specs when the people who wrote them move on, and apps a coding agent built in a week often have no record of intended behavior beyond the prompt history. With nothing to test against, a testing agent ends up grading the app against itself. Starting from the URL a developer
The Estée Lauder Companies and Microsoft Announce a New Strategic Partnership to Power Enterprise Efficiency and Consumer-Centric Growth30.10.2026 14:22:00 CET | Press release
The new collaboration will strengthen the company’s cloud, data, and AI capabilities to accelerate innovation and enhance productivity The Estée Lauder Companies Inc. (NYSE: EL) today announced a new strategic partnership with Microsoft Corp. to advance its cloud and data foundation and support the responsible adoption of AI-enabled capabilities across the enterprise. The collaboration will help connect data and intelligent tools to support faster innovation, more efficient operations, and more relevant consumer experiences. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261030616823/en/ This new partnership is a critical part of The Estée Lauder Companies’ One Operating Ecosystem, which brings together shared platforms, connected data, and best-in-class partners to enable consistent, scalable, and effective execution across the enterprise. A key initiative of this expanded partnership is harnessing the Microsoft platform to
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom