Expansion of Clinical Development of RVU120 in Low-Risk Myelodysplastic Syndromes (LR-MDS)

KRAKOW, Poland, Oct. 20, 2023 /PRNewswire/ -- Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies addressing emerging targets in oncology, announced today that it entered into a Clinical Trial Financial Support agreement for an investigator initiated clinical trial (IIT) with the European EMSCO network.

EMSCO was founded in 2012 by Prof. Uwe Platzbecker from the University Hospital Leipzig and head of the German MDS study group, and Prof. Pierre Fenaux from Hôpital Saint Louis in Paris and head of the French MDS study network GFM. Since then, the EMSCO network has been extended to other European countries and has carried out 9 common trials in MDS, of which 3 are ongoing.  

The so-called REMARK study is a Phase II RVU120 study in Low-Risk Myelodysplastic Syndromes (LR-MDS) and it will be conducted through the EMSCO network, in cooperation with GCP-Service International West.  

• The REMARK study aims at the development of RVU120 as a monotherapy for the treatment of patients with LR-MDS.
• Prof. Uwe Platzbecker, a globally renowned expert in the field of LR-MDS, will take on the role of Coordinating Principal Investigator (CPI).
• The study is an essential element of implementing Ryvu's Development Plans for 2022-2024.
• Ryvu will host a virtual webinar on further RVU120 development plans on Monday, October 23 at 9.00 am CEST.

Prof. Uwe Platzbecker, Coordinating Principal Investigator of the REMARK study, said:

- I am very pleased to conduct this study investigating RVU120 in patients with LR-MDS. This approach is supported by a strong preclinical rationale, and the currently available clinical data from the AML and HR-MDS study demonstrating hematologic improvement in many patients. I am confident that RVU120 offers potential to treat this chronic disease, and once its effectiveness is clinically validated, we will have the opportunity to greatly improve the quality of life and survival of patients in need.

- We plan to initiate the study in the first half of 2024. With our extensive expertise and the support of our broader scientific and clinical network, we are well-prepared to efficiently conduct this project.

 Hendrik Nogai, MD, Chief Medical Officer at Ryvu Therapeutics, said:

- We are delighted that Professor Uwe Platzbecker is aiming to validate the effectiveness of RVU120 in the treatment of LR-MDS. We strongly believe in the concept of this study and in the potential of RVU120 to address the existing unmet medical need. Considering Professor Platzbecker's experience as a leading expert in the field and his successful track record in designing and executing clinical programs leading to the approval of new drugs for the treatment of myelodysplastic syndromes, we expect smooth progress and generation of high-quality clinical data, which will bring us another step closer in helping patients.

- The study will be conducted as an investigator-initiated trial designed to provide clinical validation of RVU120's efficacy in treating LR-MDS, while maintaining a high level of cost-effectiveness. The study results will inform decisions about the future development of RVU120 for this indication.

As an IIT, REMARK will be a study with scientific and medical merit, developed and coordinated by the Investigator. The Clinical Trial Financial Support agreement for the REMARK study is a tripartite arrangement involving Professor Uwe Platzbecker as the Coordinating Principal Investigator, GCP-Service International West (a German Contract Research Organization sponsoring and conducting the study on behalf of the EMSCO network), and Ryvu as the financier. Ryvu will also be responsible for providing the study drug. The estimated Ryvu's financial contribution to the study is approx. EUR 4 million.

The REMARK study is planned to take place at approximately 25 clinical sites in the EU, with the primary goal of enrolling about 40 patients to generate exploratory clinical data. Start-up activities for the study are scheduled to commence later this year, and patient enrollment is planned to start in the first half of 2024.

More about Prof. Uwe Platzbecker:

Prof. Platzbecker is the Director of the Department for Hematology, Cellular Therapy, Hemostaseology and Infectious Diseases at the University Hospital Leipzig, Germany. He is the co-founder and chairman of the European MDS Studies Coordination Office (EMSCO) and co-chairman of the European Hematology Association Scientific Working Group on MDS.

Prof. Platzbecker's research interests primarily focus on myelodysplastic syndromes (MDS) and its treatment. Specifically, Prof. Platzbecker's team has worked on trials assessing luspatercept (Reblozyl) and imetelstat in patients with low-risk MDS.

More about LR-MDS:

Myelodysplastic Syndromes (MDS) are classified into high and low-risk categories. This is a group of bone marrow cancers with the potential for progression to Acute Myeloid Leukemia (AML). In the United States, more than 20,000 cases of MDS are reported annually, with approximately two-thirds falling into the low-risk category (LR-MDS). Effective therapeutic options for this chronic disease are limited, necessitating ongoing clinical research.

Webinar on RVU120 development plans

Ryvu will host a webinar on Monday, October 23, at 9:00 am CEST to discuss further RVU120 development plans. To join the webcast, please register here: https://ryvu.clickmeeting.com/ryvu-esmo-2023-results-rvu120-development-plans/register.  

About Ryvu Therapeutics   

Ryvu Therapeutics is a clinical-stage drug discovery and development company focused on novel small-molecule therapies that address emerging targets in oncology. Internally discovered pipeline candidates use diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules directed at kinases, synthetic lethality and immuno-oncology targets.

Ryvu's most advanced programs are RVU120 — a selective CDK8/CDK19 kinase inhibitor with potential for the treatment of hematological malignancies and solid tumors currently in phase I clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndromes, and phase I/II for the treatment of  r/r metastatic or advanced solid tumors — and SEL24 (MEN1703), a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group. Ryvu Therapeutics has signed multiple partnering and licensing deals with global companies, including BioNTech, Exelixis, Menarini and Merck.

The Company was founded in 2007 and is headquartered in Kraków, Poland. Ryvu is listed on the Warsaw Stock Exchange and is a component of the mWIG40 index.

More information: www.ryvu.com, Twitter, Linkedin

SOURCE Ryvu Therapeutics