Hematology/Oncology: AOP Health’s Expanding Clinical Research Program Delivers New Results
10.6.2024 14:14:00 EEST | 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 furthersignal 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/
Contact information
DI Isolde Fally
Isolde.Fally@aop-health.com
+43-676-500 4048
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Klarna Expands Partnership With Mollie, Bringing Enhanced Dispute Management and Consumer FX to Merchants Across Europe3.11.2026 11:00:00 EET | Press release
Klarna, the everyday finance network, announced today an expanded agreement with Mollie, one of Europe’s leading payment service providers. Building on their existing partnership, the new contract brings additional Klarna capabilities, including enhanced dispute management and consumer FX, to Mollie’s more than 350,000 merchants. The new features will roll out across all Mollie’s integrations, via direct API, hosted payment page and via their extensive Platform partner plug in ecosystem. Merchants already offering Klarna through Mollie will gain access to these features through their existing integration. Merchants new to Klarna can offer Pay in Full, Pay in 3 interest-free installments and Financing at checkout, and can enable it within minutes. With Mollie’s recent acquisition of GoCardless and coverage across all EEA markets, the expanded agreement extends Klarna’s reach and product offering across the region. “This deepened agreement with Mollie opens up Klarna to merchants across
Bizzmine Unveils More Than 40 Quality, EHS and Compliance Solutions Alongside Major Advances in AI and User Experience3.11.2026 10:47:00 EET | Press release
Bizzmine has announced a major expansion of its intelligent QHSE platform at Digital Summit 2026. The company presented more than 40 ready to use solutions spanning Quality, Environment, Health and Safety (EHS) and Compliance, together with advances in artificial intelligence and a fundamentally renewed user experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261102147396/en/ Bizzmine summit panel discussion The latest developments give organisations a broader range of operational processes to manage in one environment, with connected information, common governance and a clear view of responsibilities and completed work across locations. “What impresses me most is how quickly we can now turn innovation into value for our customers,” said Mark Abbas, CEO of Bizzmine. “In just one year, we have expanded from around 15 solutions to more than 40, got recognized by leading industry analysts for our EHS capabilities, introd
Hightouch Launches Match Booster in Europe, Raising Match Rates Without Compromising Compliance3.11.2026 10:02:00 EET | Press release
Hightouch, the leading agentic marketing platform, today launched Match Booster in the UK, Germany, France, Spain, and Italy. Match Booster helps brands, agencies, media networks, and publishers reach more of their customers on more than 50 ad platforms, including Google, Meta, Amazon, TikTok, and The Trade Desk, by adding to their consented first-party data instead of replacing it. Until now, European advertisers have had two options. They could send first-party data to ad platforms alone and accept the match rates they got. Or they could hand it to a traditional onboarding provider that swaps it for a proprietary ID and drops any customer its graph can’t find, sometimes leaving audiences smaller than they started. Global companies also end up running separate US and EU workflows to meet data residency rules. “Better match rates shouldn’t depend on where your customers live,” said Matthew Lubeck, General Manager, EMEA at Hightouch. “European companies have been told that more reach me
Building on Netherlands NextGen Momentum, Trilliant Showcases Why the Next Generation of AMI is Being Defined by Choice at Enlit Europe 20263.11.2026 10:00:00 EET | Press release
Trilliant, a technology platform partner enabling utilities to gain real-time visibility and optimize performance across an increasingly dynamic energy landscape, will showcase its Power of Choice approach at Enlit Europe 2026, taking place 10–12 November in Vienna, Austria. The company will highlight how intelligent software and device-independent technologies help utilities modernize infrastructure and prepare for evolving grid demands. Trilliant’s participation at Enlit Europe follows its recent selection by Dutch distribution system operators to support the Netherlands’ NextGen smart metering programme. Trilliant’s role includes developing and delivering gateways supported by its transformed UnitySuite® platform, which will be demonstrated during the conference. At Enlit Europe, Trilliant will spotlight its Power of Choice approach, enabling utilities to integrate multiple vendors and technologies without proprietary lock-in while building a foundation for next-generation AMI and g
Cambridge International AS & A Level June Series Results to Be Released Earlier From 20273.11.2026 09:05:00 EET | Press release
Students taking Cambridge International AS & A Levels will receive their June series exam results almost two weeks earlier from 2027. Results for the June 2027 series will be released on 28 July 2027, the International Education group at Cambridge University Press & Assessment (Cambridge) announced today. The change responds to feedback from schools, students and families that earlier results would make a practical difference. Earlier results give students more time to confirm university places, complete enrolment, apply for visas and arrange travel. Bringing the date forward will allow students to take up a university place in the same calendar year in some countries, where previously they could not. Earlier results will also give universities more time to review applications, confirm offers and resolve queries, and give them greater certainty when planning their international intake. University admissions processes and academic calendars vary between countries, so the benefits of an
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