Business Wire

Hematology/Oncology: AOP Health’s Expanding Clinical Research Program Delivers New Results

Share

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/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

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

  1. 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.
  2. 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.
  3. 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.
  4. 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.

Contact information

DI Isolde Fally
Isolde.Fally@aop-health.com
+43-676-500 4048

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.com

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

Carestream Secures Crucial Business Partner Agreement in Peru17.6.2024 18:14:00 CEST | Press release

Carestream Health recently secured an agreement with Distribuidora Diagnostica Medica SAC (DMD), a leading distributor of radiology solutions in Peru, to convert the latter’s customers and install base to Carestream products. Additionally, under the terms of the agreement, DMD will become an exclusive Carestream distributor in the region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240617561378/en/ Carestream DRYVIEW 5700C (Photo: Business Wire) As part of the deal, DMD purchased 80 DryView printers, which together have a projected print volume of more than 60,000 square feet in 2024 and over 100,000 square feet in 2025 and beyond. “We are excited to be joining forces with a strong organization like DMD,” said Miguel Nieto, Carestream’s Director of the Americas Region & General Manager of LATAM Consumables Business. “Not only are they one of the leading providers in Peru, but they have a strong track record of taking care

Cognite Atlas AI™ Delivers Specialized Industrial Agents, Virtual Employees Tailored to Provide Domain-Specific Insights and Automate Complex Industrial Tasks17.6.2024 15:00:00 CEST | Press release

Cognite, the globally recognized authority in Data and AI for industry, today announced Cognite Atlas AI™, an industrial agent workbench that extends Cognite’s Industrial DataOps platform, Cognite Data Fusion®. This strategic offering is a culmination of Cognite’s extensive Industrial DataOps and innovative generative AI capabilities. Cognite Atlas AI’s low-code industrial agent builder will enable industrial organizations to use generative AI to carry out more complex operations with greater accuracy, including workflow automation and decision-making support, accelerating efficiencies that can generate tens of millions of dollars in business impact. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240613136987/en/ Cognite Atlas AI enables low-code development of AI agents that increase the accuracy of industrial AI, accelerate efficiencies, and drive business impact (Graphic: Cognite) Cognite Atlas AI provides domain-specific

Takeda Announces Phase 3 Topline Results for Soticlestat (TAK-935) in Patients with Dravet Syndrome and Lennox-Gastaut Syndrome17.6.2024 12:45:00 CEST | Press release

Takeda (TSE:4502/NYSE:TAK) today announced topline data from its SKYLINE and SKYWAY studies. SKYLINE (TAK-935-3001) was a multicenter, randomized, double-blind Phase 3 study that evaluated soticlestat (TAK-935) plus standard of care versus placebo plus standard of care in patients with refractory Dravet syndrome (DS).1 Soticlestat narrowly missed the primary endpoint of reduction from baseline in convulsive seizure frequency as compared to placebo (p-value = 0.06). Among the six key secondary endpoints, soticlestat showed clinically meaningful and nominally significant results in the responder rate, measures of caregiver and clinician global impression of improvement, and seizure intensity and duration scales over the 16-week treatment period (all p-values ≤ 0.008). SKYWAY (TAK-935-3002) was a multicenter, randomized, double-blind Phase 3 study that evaluated soticlestat plus standard of care versus placebo plus standard of care in patients with refractory Lennox-Gastaut syndrome (LGS)

Dubai becomes the world metropolis for artificial intelligence17.6.2024 11:13:00 CEST | Press release

Dubai is increasingly becoming a global center for artificial intelligence. To this end, the metropolis of the day after tomorrow on the Gulf has pledged to train one million people in AI prompting over the next three years with Dubai Future Foundation overseeing the AI prompt program.. It is the first program of its kind in the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240613025960/en/ Omar Al Olama, the UAE´s Minister of State for AI, Digital Economy, and Remote Work Applications. (Photo: Business Wire) “We want to be the most future-ready city and continue to prepare for the AI era by developing expertise and skills that support global technological change and put Dubai at the forefront of innovation,” said the Chairman of the Board of Trustees of the Dubai Future Foundation (DFF), Crown Prince Sheikh Hamdan bin Mohammed bin Rashid Al Maktoum, at the launch of the 'One Million AI Prompters' initiative in Dubai

KAYTUS Support for Intel ® Xeon ® 6 Processors - Unmatched AI Performance and Eco-Efficiency17.6.2024 09:02:00 CEST | Press release

KAYTUS, a leading IT infrastructure provider, announces that its servers now support the newly released Intel® Xeon® 6 Processors, which offer outstanding performance and energy efficiency, setting a new standard in the industry. Compared to servers equipped with 3rd Gen Intel® Xeon® Scalable Processors, the updated KAYTUS servers deliver a 200% performance boost and a 230% improvement in performance per watt, rigorously verified in virtualization scenarios and tasks such as decompression, video transcoding, and pgbench. The significant enhancement in performance per watt provides greener and more powerful computing support for diverse applications, including AI, cloud-native environments, and data analytics. KAYTUS continues to ensure that its clients benefit from the latest advancements in technology, achieving exceptional efficiency and performance. With the continuous development of artificial intelligence, particularly the rapid expansion and widespread application of AI technolog

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
HiddenA line styled icon from Orion Icon Library.Eye