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

By Investor Empires On Jun 10, 2024

VIENNA — AOP Orphan Pharmaceuticals GmbH (AOP Health) continues a successful clinical research program in hematology/oncology by accepting two abstracts for presentation at the 2024 European Hematology Association (EHA) Hybrid Congress in Madrid, Spain. One leads to an oral presentation of the latest results from the PROUD-PV and CONTINUATION-PV trials. Results show an association between changes at the genetic level (molecular response) and event-free survival (EFS) among patients with a rare leukemia (polycythemia vera/PV) who received a specific interferon (ropeginterferon alfa-2b/BESREMi®). . Or the best treatment available¹ A second abstract reports on a phase III clinical study recently initiated by AOP Health to expand the investigation of robeginterferon alfa-2b for patients with another rare blood cancer, essential thrombocytosis (ET), has been accepted.²In furtherA sign of AOP Health's commitment to innovative research, early development of a first-in-class investigational oncology drug is progressing toward clinical trials.

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Reduction of transformed cells improves event-free survival in patients with PV and is effectively achieved by robeginterferon alfa-2b.

Latest findings from the large randomized controlled trial PROUD-PV and its extension CONTINUATION-PV³ showed that ropiginterferon alfa-2b reduced the amount of cells carrying a mutation in a specific gene (JAK2V617F, a gene that regulates cellular growth) in the group of patients studied.³ Analysis of all patients included in the trial over at least 6 years showed prolonged event-free survival (the period during which patients remain free of the events that treatment was intended to prevent or delay) among patients in whom the amount of transformed cells decreased at Latest rating available.

Professor Jean-Jacques Kiladjian from the University of Paris, France, first author of the paper, confirms: “This new evidence supports the clinical importance of reducing pregnancy-related stress.” JAK2V617F mutations to improve long-term outcomes in patients with PV, which should be considered as a target for treatment. Ropeginterferon alfa-2b targets transformed hematopoietic stem cells and is highly effective in reducing mutation burden. JAK2“V617F gene.”

A phase III clinical study of robeginterferon alfa-2b in ET is underway in Europe

With the goal of examining the potential benefit of robeginterferon alfa-2b in ET patients with high unmet need, AOP Health launched the ROP-ET trial, a prospective, multicenter, single-arm phase III study to evaluate long-term safety. and the efficacy of robeginterferon alfa-2b in ET patients unable to receive available cellular therapies.⁴ The trial is being conducted at 36 sites in 10 countries in Europe. Nearly 50% of the required number of patients have already been enrolled in the study. This rapid recruitment underscores the importance of the clinical trial.

New drug candidate: official start of clinical development imminent

Building on proven success in developing cancer stem cell targeting therapies, AOP Health is expanding into a new area of research with a first-in-class investigational oncology drug candidate. The highly selective, orally available serotonin 1B receptor antagonist was discovered and initially developed by Leukos Biotech based on research conducted at the Josep-Carreras Institute for Leukemia Research and has been licensed by AOP Health for further development and commercial rights. SERONCO-1, Phase 1, a first-in-human trial in patients with solid tumors and lymphomas, will be conducted in collaboration with Leukos Biotech at the Vall d'Hebron Oncology Institute (VHIO) with partial funding from the Spanish Ministry of Science. and Innovation through the Public-Private Partnership Program (CPP2021-008715). A subsequent trial for acute myeloid leukemia is expected to begin in 2026.

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References

Kiladjian JG, Kled C, Georgiev P, et al. JAK2V617F molecular response is associated with event-free survival in an early-onset population of polycythemia. 2024. https://library.ehaweb.org/eha/2024/eha2024-congress/422323 Last accessed May 27, 2024.
Kiladjian JJ, Ferrer-Marin F, Al-Ali FK, et al. ROP-ET: A prospective phase III trial examining the efficacy and safety of ROPEGINTERFERON ALFA-2B in patients with primary thrombocythemia with limited treatment options. 2024. https://library.ehaweb.org/eha/2024/eha2024-congress/421616. Last accessed May 27, 2024.
Geislinger H, Kled C, Georgiev P, et al. Event-free survival in patients with polycythemia vera treated with robeginterferon alfa-2b versus best available therapy. blood cancer. 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 robeginterferon alfa-2b in patients with essential thrombocythemia who have limited treatment options. Annals of Hematology. 2024 Mar 4: 1-2.

About BESREMi®

BESREMi® is a long-acting monoproline interferon (ATC L03AB15). Its unique pharmacological properties provide a new level of tolerability. BESREMi® is designed to be conveniently self-administered subcutaneously with a pen once every two weeks, or even monthly after hematological parameters have stabilized. This treatment schedule is expected to improve overall safety, tolerability, and adherence compared with conventional interferons.

Nearly 7,800 patients are currently being treated or have been treated with BESREMi®.

For an EMA summary of product characteristics, please visit: Pressremi®

connection: https://www.ema.europa.eu/en/documents/product-information/besremi-epar-product-information_en.pdf

Ropeginterferon alfa-2b was discovered by PharmaEssentia, a long-standing partner of AOP Health. In 2009, AOP Health licensed the exclusive rights to clinical development and commercialization of Ropeginterferon alfa-2b in PV and other MPNs such as chronic myelogenous leukemia (sml) For European, CIS and Middle East markets.

About the validity of AOP

the AOP Health Group It includes several companies including AOP Orphan Pharmaceuticals GmbH headquartered in Vienna, Austria (“AOP Health“). AOP Health Group is a European leader in integrated treatments for rare diseases and critical care. Over the past 25 years, the Group has become an established provider of integrated treatment solutions operating from its headquarters in Vienna, its subsidiaries and representative offices across Europe and the Middle East, as well as through partners around the world. This development has been made possible thanks to the continuous high level of investment in R&D on the one hand and a consistent and very practical orientation towards the needs of all stakeholders on the other hand – especially patients and their families but also healthcare professionals who. They treat them.

needs. Sciences. trust.
AOP Orphan Pharmaceuticals GmbH
Member of AOP Health Group