RVU120 to be tested in an investigator-initiated Phase I studytotreatpediatric patients withmedulloblastoma
The Management Board of Ryvu Therapeutics S.A., with its' registeredoffice in Kraków, Poland ("Company", "Ryvu"), informs about theinitiation of a collaboration with the Children's Memorial HealthInstitute (pl. Instytut "Pomnik - Centrum Zdrowia Dziecka", "IPCZD","the Institute") as part of the MEDWAY project ("MEDWAY Project") - anew, non-commercial Phase I clinical study aimed to evaluate the CDK8/19inhibitor RVU120 in combination with everolimus in children withrecurrent or progressive Group 3 or 4 medulloblastoma. On September 9,2025, IPCZD signed a funding agreement with the Polish Medical ResearchAgency (pl. Agencja Badań Medycznych "MDR") for the MEDWAY Project undera grant awarded in ABM's call for non-commercial clinical trials andresearch experiments in oncology (ABM/2024/2). The study will assess thesafety and potential efficacy of RVU120 in combination with everolimus,targeting unique molecular mechanisms of the disease.
The study will be led by Prof. Bożenna Dembowska-Bagińska and theclinical team at IPCZD's Oncology Clinic, in collaboration with theresearch teams of Prof. Wiesława Grajkowska and Prof. Joanna Trubicka.The MEDWAY Project will be supported by the Pediatric Clinical TrialsSupport Center and the Pediatric Regional Center for Digital Medicineoperating at IPCZD. Medulloblastoma is one of the most common andaggressive forms of childhood brain cancer, with limited treatmentoptions, especially for recurrent or progressive cases.
The total value of the grant awarded to IPCZD under the MEDWAY Projectis PLN 40,151,060.47. Of this amount, approximately PLN 2 million isallocated in the MEDWAY Project budget directly to cover the costs ofmanufacturing, preparing, and releasing the investigational medicinalproduct - RVU120 - for use in the planned clinical trial. These fundscover only the production costs, excluding commercial markups ormargins, however the Company will not bear any costs related to thesupply of RVU120 for the study. The first shipment of RVU120 is expectedin Q2 2026. The MEDWAY Project is expected to run from July 1, 2025, toJune 30, 2033 with the potential for earlier completion. Ryvu will workclosely in collaboration with the IPCZD team throughout the study.
Disclaimer: This English language translation has been prepared solelyfor the convenience of English-speaking readers. Despite all the effortsdevoted to this translation, certain discrepancies, omissions orapproximations may exist. In case of any differences between the Polishand the English versions, the Polish version shall prevail. RyvuTherapeutics S.A., its representatives and employees decline allresponsibility in this regard.