Ryvu launches Keelira as dedicated early clinical development business
Ryvu Therapeutics, a clinical-stage oncology drug discovery and development company headquartered in Krakow, Poland, and listed on the Warsaw Stock Exchange (WSE: RVU), has launched Keelira, a dedicated business unit offering early clinical development services to biotech and pharma companies seeking to extend oncology programmes into Europe.
Keelira is positioned as a sponsor-side offering for companies, including those based in the US and China, that wish to bring oncology assets into European clinical development. The business draws on multi-country experience and established relationships with oncology sites across key European markets. Keelira supports companies from preparation for clinical entry through Phase I and Phase II development, with particular depth in oncology, hemato-oncology and rare cancers. Based in Poland, it combines an established operating base with the capacity to extend studies into additional EU and non-EU countries as programmes require.
CRO Plus model combines execution and advisory functions
Keelira describes its offering as a “CRO Plus” model, bringing Clinical Execution, Strategic Advisory and Central Lab functions together within a single team. This is intended to give sponsors one point of accountability, supported by direct Phase I and Phase II oncology experience. Strategic Advisory connects regulatory, chemistry, manufacturing and controls (CMC), and data-readiness planning directly with execution, with the aim of translating development strategy into an executable clinical plan.
Kamil Sitarz, PhD, General Manager of Keelira, said: “Bringing an oncology programme into Europe requires regulatory strategy, development planning, site selection and clinical execution to move together from the outset. Keelira gives sponsors one coordinated team across these workstreams: they retain control of the asset, strategy and key decisions, while we take responsibility for execution.”
Central laboratory capability set to expand
At launch, Keelira’s Central Lab function includes Good Clinical Laboratory Practice (GCLP) compliant sample management and storage. The company has indicated plans to expand this into integrated pharmacokinetic (PK), pharmaco-dynamic (PD) and biomarker analysis, which would extend its laboratory remit alongside its clinical operations offering.
The operating model underpinning Keelira was developed within Ryvu to advance its own oncology pipeline, including operational responsibility for Phase II studies and multi-country site activation and patient enrolment across haematological malignancies and solid tumours. This experience has since been applied to external clinical collaborations. Keelira’s investigator network builds on relationships established through Ryvu’s work with more than 70 oncology sites in Poland, more than 20 in Spain, and more than 15 each in France and Italy, providing a base for multi-country patient recruitment in rare oncology indications.
Ryvu has stated that external client programmes will be managed separately from its internal drug-development activities, under a dedicated quality management system, with separate data-management arrangements and client-specific governance intended to maintain independence between the two functions.
For more information, visit: www.keelira.com
