KRAKOW, Poland, September 09, 2025 / Biotech Newswire / -- Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focused on novel therapies targeting emerging oncology indications, announces its involvement in the MEDWAY project with a new non-commercial academic Phase I study to evaluate the CDK8/19 inhibitor RVU120 in combination with everolimus in children with recurrent or progressive Group 3 or 4 medulloblastoma.
The MEDWAY project will be executed by the Children’s Memorial Health Institute (IPCZD) under the grant awarded in the Medical Research Agency call (ABM/2024/2) for non-commercial clinical trials and research experiments in oncology. At IPCZD, the study is led by Prof. Bożenna Dembowska-Bagińska and the clinical team from Department of Pediatric Oncology in collaboration with Prof. Wiesława Grajkowska’s and Prof. Joanna Trubicka’s research group. The project will be supported by the Clinical Trial Support Center and Regional Center for Digital Medicine at IPCZD.
Medulloblastoma, one of the most common and aggressive forms of childhood brain cancer, has limited treatment options, especially for recurrent or progressive cases. These challenging relapses are often resistant to standard therapies, highlighting the urgent need for innovative, targeted treatment strategies. This trial will investigate the safety and potential efficacy of RVU120, in combination with everolimus, targeting the disease's unique molecular mechanisms.
Prof. Bożenna Dembowska-Bagińska, M.D., pediatric oncologist, Deputy Director for Clinical Affairs, IPCZD said: "We are enthused to receive this grant from ABM and work with Ryvu to bring RVU120 as a potentially life-saving treatment to children with brain tumor. There is a high unmet need in recurrent pediatric medulloblastoma, and the awarding of this grant reflects the clinical rationale and potential benefit of RVU120 in combination with everolimus in these patients. The teams at IPCZD and Ryvu are both dedicated to improving the lives of children with cancer, and we are looking forward to working together on this clinical study."
Hendrik Nogai, M.D., Chief Medical Officer of Ryvu Therapeutics said: "We are honored to contribute to this important clinical trial, and we’re excited to see RVU120 being tested in pediatric patients with medulloblastoma. This unique partnership is a potentially significant step forward in addressing a high unmet need in pediatric oncology. We would like to express our deep appreciation to all the project partners, especially the Children’s Memorial Health Institute, for their trust and commitment to this important collaboration."
The total grant awarded to IPCZD amounts to PLN 40,151,060.47. Within this budget, approximately PLN 2 million has been allocated specifically to cover the direct costs associated with the manufacturing, preparing, and releasing the investigational medicinal product RVU120 for use in the planned clinical trial (production expenses only, with no additional margin or commercial markup included). The first shipment of the drug is expected in Q2 2026. The MEDWAY project is expected to run from July 1, 2025, to June 30, 2033 with the potential for earlier completion. Ryvu will work closely in collaboration with the IPCZD team throughout the study.
The use of RVU120 in the MEDWAY trial underscores Ryvu's ongoing commitment to advancing innovative therapies for patients with high unmet medical needs. Medulloblastoma, particularly its recurrent or progressive forms, continues to have poor long-term survival rates due to the limited effectiveness of current treatment options.
About Ryvu Therapeutics
Ryvu Therapeutics is a clinical-stage drug discovery and development company focused on novel oncology therapies that address emerging targets in oncology. Internally discovered pipeline candidates at Ryvu use diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules and antibody-drug conjugates directed at kinases, synthetic lethality, and immuno-oncology targets.
Ryvu’s most advanced program is RVU120, a selective CDK8/CDK19 kinase inhibitor with the potential to treat hematological malignancies. RVU120 is currently in Phase II development (i) in combination with venetoclax for the treatment of patients with r/r AML – the RIVER-81 study, (ii) as a monotherapy for the treatment of patients with lower-risk myelodysplastic syndromes (LR-MDS) – the REMARK study, (iii) as a monotherapy and in combination with ruxolitinib for the treatment of patients with myelofibrosis (MF) – the POTAMI-61 study. Dapolsertib (MEN1703, SEL24) is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group that is currently being investigated in a Phase II study in diffuse large B-cell lymphoma (DLBCL) – the JASPIS-01 study. RVU305, a potentially best-in-class, brain-permeable PRMT5 inhibitor aiming to treat multiple solid tumors, is currently in IND/CTA-enabling studies. Ryvu Therapeutics is also engaged in oncology collaborations with BioNTech and Exelixis.
Ryvu was founded in 2007 and is headquartered in Kraków, Poland. It is listed on the Warsaw Stock Exchange and is a component of the sWIG80 index.
Contact
Ryvu Therapeutics
Anna Wilk
+48 532 698 425
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Keywords: Clinical Trials, Phase I as Topic; Medulloblastoma; Everolimus; Brain Neoplasms; Brain; Cerebellar Neoplasms; Ryvu Therapeutics; RVU120; CDK8/19 inhibitor; Phase I study; pediatric patients; medulloblastoma; MEDWAY project; recurrent medulloblastoma; progressive medulloblastoma; everolimus; Prof. Bożenna Dembowska-Bagińska; Prof. Wiesława Grajkowska; Prof. Joanna Trubicka; childhood brain cancer; Hendrik Nogai, M.D.; Kraków, Poland; Warsaw Stock Exchange (WSE: RVU)
Source: Biotech Newswire