Ryvu Therapeutics has launched Keelira, a dedicated early clinical development services business designed to help biotechnology and pharmaceutical companies bring oncology programs into Europe.
Based in Krakow, Poland, Keelira will support sponsors from clinical-entry preparation through Phase 1 and Phase 2 development, with specialized experience in oncology, hemato-oncology and rare cancers. The business will target companies based in Europe as well as the United States and China that need regulatory, operational and site-level support for European clinical trials.
Keelira’s operating model was developed within Ryvu to support its internal oncology pipeline and was later used in external collaborations. Ryvu said the model has included operational responsibility for Phase 2 studies, multi-country site activation and patient enrollment in programs involving hematologic malignancies and solid tumors.
The new business will operate under a “CRO Plus” model that combines clinical execution, strategic advisory services and central laboratory capabilities in one team. The approach is intended to give sponsors a single point of accountability while allowing them to retain control of their assets, development strategy and major decisions.
Clinical execution will serve as the core offering. Keelira’s strategic advisory services will link regulatory planning, chemistry, manufacturing and controls activities, and data-readiness planning directly to trial execution, according to the company. The objective is to turn development strategy into an operational clinical plan.
At launch, Keelira’s central laboratory services will include Good Clinical Laboratory Practice-compliant sample management and storage. The company plans to expand these capabilities to include integrated pharmacokinetic, pharmacodynamic and biomarker analysis.
Keelira said it will have an established operating base in key European markets, with the ability to extend studies into additional European Union and non-EU countries as programs require. Its team has experience supporting Phase 1 and Phase 2 programs, including multi-country recruitment for rare oncology indications.
General Manager Kamil Sitarz said European oncology development requires regulatory strategy, development planning, site selection and trial execution to be coordinated from the start. He said Keelira aims to manage those workstreams through one team while sponsors retain strategic control.
External client work will be separated from Ryvu’s internal drug-development activities through a dedicated quality management system, separate data-management arrangements and client-specific governance.