Cardiff Oncology and NMS settle dispute and expand onvansertib deal

Cardiff Oncology and Nerviano Medical Sciences (NMS) have settled all outstanding litigation and amended the exclusive licence agreement governing onvansertib, the NASDAQ-listed biotech's lead PLK1 inhibitor, with both parties agreeing to jointly seek dismissal of US federal court claims with prejudice.

The settlement, announced on 14 September 2026, resolves a dispute that had been pending in the US District Court for the Southern District of California and clears Cardiff's path toward a registrational Phase 3 study of onvansertib in first-line RAS-mutated metastatic colorectal cancer (mCRC).

Terms of the amended agreement

Under the revised framework, Cardiff and NMS have clarified and expanded the royalty structure in the original 2017 licence. NMS gains the right to appoint a board observer and a seat on Cardiff's Scientific Advisory Board, embedding the Italian drug-discovery company more deeply in Cardiff's governance as onvansertib advances. The amended agreement also sets out development milestones tied to Cardiff's forthcoming Phase 3 programme.

Mani Mohindru, president and chief executive of Cardiff Oncology, said the amendment "strengthens our long-term rights to onvansertib as a promising treatment for cancer, beginning with first-line RAS-mutated metastatic colorectal cancer." NMS Group chief executive Hugues Dolgos said both companies are committed to advancing onvansertib into a global Phase 3 study.

Clinical backdrop and market context

Onvansertib is an oral, highly specific inhibitor of polo-like kinase 1 (PLK1), a mitotic regulator that is overexpressed in a range of solid tumours. In a randomised Phase 2 trial, onvansertib combined with FOLFIRI and bevacizumab demonstrated dose-dependent improvements in overall response rate and progression-free survival versus standard of care alone in first-line RAS-mutated mCRC patients. Cardiff has selected the 30 mg dose for Phase 3 advancement.

RAS-mutated mCRC represents a substantial unmet need. RAS mutations, including KRAS and NRAS variants, are present in roughly 50% of metastatic colorectal cancer cases and historically confer resistance to EGFR-directed therapies, leaving patients reliant on chemotherapy doublets combined with bevacizumab or, more recently, immune checkpoint inhibitors in microsatellite instable subgroups. A targeted oral agent that improves outcomes in this RAS-mutated population would address a gap that multiple development programmes have attempted to fill over the past decade, with limited success.

PLK1 inhibition as a strategy has attracted periodic interest from large pharmaceutical companies, and Cardiff is among the few clinical-stage developers maintaining an active registrational-track PLK1 programme in solid tumours. The resolution of the NMS licence dispute removes an overhang that had the potential to cloud Cardiff's IP position and complicate any future partnering discussions ahead of Phase 3 initiation.

For NMS, the arrangement provides governance visibility into a late-stage asset while allowing the Italian company to retain its royalty economics. NMS operates across oncology small molecules and antibody-drug conjugates, and a successful Phase 3 readout for onvansertib would represent a significant validation of its historic PLK1 discovery work.

Near-term milestones to watch include the formal Phase 3 trial initiation date, any further disclosure of the expanded royalty terms, and whether Cardiff pursues a co-development or commercial partnership before the registrational study fully enrols.