Hematology/Oncology: AOP Health’s Expanding Clinical Research Program Delivers New Results
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
Geoswift Launches Visa Direct to Enhance Cross-Border Payment Offers in Over 30 Countries30.4.2025 04:00:00 EEST | Press release
Geoswift announced today the integration of Visa Direct with Geoswift's cross-border payments platform. Visa Direct facilitates payouts to more than 140 countries and territories. The integration will enable payouts in 32 countries and territories, across 13 currencies, covering major markets in Asia Pacific, North America, Europe and Middle East, with plans for more in the future. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250423288249/en/ Bryan Ma, SVP, Head of Geoswift Global Payments, and Swapnil Mhasde, Head of Visa Direct Commercialization and Solutions, Asia Pacific, celebrating the launch in Singapore. Geoswift is a leading provider of cross-border payment services and solutions globally. With over two decades of innovation, it has become a trusted name in B2B, education, eCommerce, remittance, and travel payment use cases. Raymond Qu, Group CEO of Geoswift, stated, "At Geoswift, our vision has always been to del
Logitech Announces Q4 and Full Fiscal Year 2025 Results29.4.2025 23:03:00 EEST | Press release
SIX Swiss Exchange Ad hoc announcement pursuant to Art. 53 LR — Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the fourth quarter and full Fiscal Year 2025 ended March 31, 2025. For Fiscal Year 2025: Sales were $4.55 billion, up 6 percent in US dollars and 7 percent in constant currency, compared to the prior year. GAAP operating income was $655 million, up 11 percent compared to the prior year. Non-GAAP operating income was $775 million, up 11 percent compared to the prior year. GAAP earnings per share (EPS) was $4.13, up 7 percent compared to the prior year. Non-GAAP EPS was $4.84, up 14 percent compared to the prior year. Cash flow from operations was $843 million. The year-ending cash balance was $1.5 billion. The Company returned $797 million of cash to shareholders through its annual dividend payment and share repurchases. For Q4 Fiscal Year 2025: Sales were $1.01 billion, flat in US dollars and up 2 percent in constant currency, compared
U.S. Patent and Trademark Office Invalidates Pharmacyclics Patent Asserted Against BeiGene29.4.2025 22:32:00 EEST | Press release
BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced that the U.S. Patent and Trademark Office (USPTO) rendered a Final Written Decision invalidating all claims of Pharmacyclics LLC’s (Pharmacyclics) U.S. Patent No. 11,672,803 (the ‘803 patent) that were challenged by BeiGene in a post-grant review (PGR) proceeding. On November 1, 2023, BeiGene filed a PGR petition with the USPTO challenging the validity of certain claims of the ‘803 patent, in response to a patent infringement lawsuit Pharmacyclics brought against BeiGene concerning BRUKINSA® (zanubrutinib). On May 1, 2024, the USPTO granted BeiGene’s petition to institute the PGR. The USPTO’s Final Written Decision is appealable by Pharmacyclics. Commenting on the ruling, BeiGene General Counsel Chan Lee said: “We are pleased that the USPTO invalidated all challenged claims of the ‘803 patent. Today’s decision reinforces our belief th
One out of Three Secure Civil IDs Delivered Each Year Is Powered by Thales29.4.2025 17:50:00 EEST | Press release
Each year, Thales powers one in three smart civil IDs (official electronic documents) issued worldwide, highlighting the company’s key role in shaping the future of identities and helping governments and citizens transition smoothly to digital. With its Civil Identity Suite, Thalesenables the issuance and management of both physical and digital identities, as well as all means of enrolling citizens and enabling seamless ID verification for access to services, both in-person and online. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250429687137/en/ Thales Civil Id Suite (Photo: Thales Shutterstock) Thales, a global leader in advanced technologies and #1 global leader in ID documents, has recently earned the new title of #1 provider of Digital ID solutions as recognized by Juniper Research (2024). With unmatched experience and scale, Thales empowers governments to modernise their identity systems, ensuring they meet the deman
Andersen Global Enhances European Valuation Capabilities through Collaboration with Value & Risk Valuation Services29.4.2025 16:30:00 EEST | Press release
Andersen Global continues to strengthen its valuation capabilities through a Collaboration Agreement with Value & Risk Valuation Services, a prominent European valuation firm headquartered in Germany with offices in Luxembourg and Austria. Founded in 1996, Value & Risk Valuation Services is a management-owned firm specializing in the valuation of financial assets across diverse asset classes and varying complexities. The firm also provides complementary services, including independent price verification (IPV), risk analysis, and transaction cost analysis. Since 2009, the company has been led by Gil Bender, who is dedicated to delivering high-quality, client-centric valuation solutions. As one of the few European providers offering external valuation services in compliance with the European Alternative Investment Fund Managers Directive (AIFMD), Value & Risk upholds the highest industry standards for regulatory compliance and service excellence. “Since our inception, we have focused on
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