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
ClickHouse Appoints New Leader for Asia Pacific and Expands Global Go-To-Market Leadership Team9.6.2026 01:45:00 EEST | Press release
ClickHouse, a leader in real-time analytics, data warehousing, observability, and AI/ML, today announced a significant expansion of its global go-to-market (GTM) leadership team, headlined by the appointment of Ed Lenta as Vice President, Asia Pacific and Japan (APJ). The additions build on the momentum established last year with the appointment of Kevin Egan as Chief Revenue Officer, and reflect ClickHouse's strategic investment in scaling its global organization to meet surging customer demand. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260608754768/en/ Ed Lenta, Vice President, Asia Pacific and Japan (APJ), ClickHouse Lenta joins ClickHouse to lead the company's go-to-market efforts across the APJ region. He brings deep experience scaling cloud and data platform businesses across the region, most recently as General Manager of Asia Pacific and Japan at Databricks, where he managed operations across more than twenty co
Money20/20 Europe Celebrates Ten Years of Industry Leadership as AI, Digital Assets and Financial Sovereignty Take Centre Stage8.6.2026 18:37:00 EEST | Press release
Money20/20, the world's leading fintech show and the place where money does business, celebrated a major milestone with its 10th Europe edition, convening more than 7,500 attendees, one in three at C-suite level, and over 2,300 companies from over 105 countries in Amsterdam, for three days of industry-defining announcements, strategic partnerships, and dealmaking that set the agenda for the future of financial services. Featuring more than 450 speakers across six stages, Money20/20 Europe welcomed leaders from banking, fintech, payments, policy, technology and digital assets to explore the forces reshaping the future of money. “This year’s show demonstrated that financial services have entered a new phase of transformation,” said Bryony Naylor, Vice President of Money20/20 Europe. “Across the show floor and on stage, we saw leaders move beyond discussing what’s next to actively building it. From AI and digital identity to financial sovereignty and digital assets, the conversations and
Liberty Latin America Selects BTS as Exclusive A2P Messaging Managed Services Partner Across All Its Markets8.6.2026 18:36:00 EEST | Press release
BTS announced today that it has been chosen as the exclusive provider of managed A2P SMS services for Liberty Latin America (LLA), supporting the company’s efforts to strengthen revenue protection, fraud mitigation, traffic intelligence, and operational visibility across its markets. The agreement reinforces LLA’s A2P messaging strategy throughout a broad regional footprint and establishes a coordinated operating model to improve control, visibility, and monetization of A2P traffic across its markets. The partnership will support revenue maximization, stronger fraud protection and grey-route mitigation, enhanced real-time traffic visibility, operational reporting and analytics, revenue assurance, and 24x7x365 managed services support. The agreement spans 25 markets and reflects a high level of operational trust in BTS’ ability to deliver consistent performance across diverse regulatory, technical, and commercial environments. “This agreement gives us a stronger and more consistent oper
The Estée Lauder Companies Strengthens UK Manufacturing Network as Whitman Facility Celebrates 60 Years of British Craftsmanship8.6.2026 18:14:00 EEST | Press release
As The Estée Lauder Companies’ (NYSE: EL) Whitman manufacturing facility celebrates its 60th anniversary, the company today announced a strategic investment that will strengthen its UK manufacturing network, further reinforcing its long-standing commitment to British craftsmanship, innovation, and growth in prestige fragrance. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260608415843/en/ From left to right: Jo Dancey, Global Brand President, Jo Malone London; Alex Gregorian, SVP, Global Manufacturing & Engineering; Roberto Canevari, Chief Value Chain Officer; Nadine Graf, President, EUKEM; Stéphane de La Faverie, President and Chief Executive Officer; William P. Lauder, Chair of the Board of Directors; Maria Genouzos, VP, EUKEM and APAC Manufacturing; Pernilla Nyberg, SVP, General Manager, UK & Ireland; Jamal Chamariq, SVP, EUKEM & TR Value Chain; and Ben Smith, Whitman Plant Manager, celebrate the 60th anniversary of The
IQM and Real Asset Acquisition Corp. Announce Effectiveness of Registration Statement for Proposed Business Combination8.6.2026 17:16:00 EEST | Press release
IQM Finland Oy, a global leader in full-stack superconducting quantum computers (“IQM”, “IQM Quantum Computers” or the “Company”), and Real Asset Acquisition Corp. (Nasdaq: RAAQ), a special purpose acquisition company (“RAAQ”), announced today that the registration statement on Form F-4 (the “Registration Statement”), relating to their previously announced business combination, has been declared effective by the U.S. Securities and Exchange Commission (“SEC”) on June 5, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260608520188/en/ IQM Radiance quantum computer The extraordinary general meeting of RAAQ’s shareholders in connection with the proposed business combination (the “Extraordinary General Meeting”) will be held on June 25, 2026. The proxy statement/prospectus relating to the Extraordinary General Meeting was mailed to RAAQ’s shareholders of record as of the close of business on June 3, 2026 (the “Record Date”)
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