Cardiff Oncology, Inc. (NASDAQ: CRDF) and Nerviano Medical Sciences S.r.l. (NMS) announced a settlement and amendment to their 2017 Exclusive License Agreement, resolving all outstanding disputes related to global rights for onvansertib, a PLK1 inhibitor drug candidate.

The two companies agreed to a full and mutual release of all claims in litigation pending in the U.S. District Court for the Southern District of California, and plan to jointly request dismissal of all claims with prejudice.

The amended agreement clarifies and expands the royalty structure of the original license and includes development objectives tied to Cardiff's planned Phase 3 program. Under the terms, NMS gains the right to appoint a board observer and join Cardiff's Scientific Advisory Board.

Both parties stated they intend to collaborate on advancing onvansertib into a global Phase 3 study targeting first-line RAS-mutated metastatic colorectal cancer (mCRC).

"This Amendment strengthens our long-term rights to onvansertib as a promising treatment for cancer, beginning with first-line RAS-mutated metastatic colorectal cancer," said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology.

Hugues Dolgos, PharmD, Chief Executive Officer of NMS Group S.r.l., said the company looks forward to working with Cardiff to advance onvansertib into a global Phase 3 study and bring the therapy to patients.

Onvansertib is an oral PLK1 inhibitor. In a randomized Phase 2 trial, it demonstrated dose-dependent improvements in overall response rate and progression-free survival when combined with FOLFIRI/bevacizumab compared to standard-of-care alone in first-line RAS-mutated mCRC patients. Cardiff has selected the 30 mg dose for advancement into a registrational trial.