Racura Oncology has announced that the first patient has been dosed in its Phase 1a/b HARNESS-1 clinical trial evaluating RC220 in combination with osimertinib for the treatment of epidermal growth factor receptor-mutant (EGFR-mutant) Non-Small Cell Lung Cancer (NSCLC). The first participant received RC220 at a dose of 50 mg/m² through intravenous infusion, with no adverse events reported following the initial treatment.

The HARNESS-1 trial is designed to assess the safety and potential effectiveness of combining RC220, Racura’s proprietary formulation of (E,E)-bisantrene, with osimertinib (Tagrisso), the current standard-of-care third-generation EGFR Tyrosine Kinase Inhibitor (TKI) for EGFR-mutant NSCLC. The study aims to determine whether the combination can delay or prevent the development of resistance to EGFR-targeted therapy, a major challenge in the long-term treatment of patients with this form of lung cancer.

Although EGFR TKIs have significantly improved outcomes for patients with EGFR-driven NSCLC, many eventually develop resistance to treatment, limiting the long-term benefits of therapy. RC220 is being investigated for its ability to target G4-DNA and RNA structures, including MYC-associated growth pathways, which researchers believe may help overcome or delay therapeutic resistance.

Commenting on the milestone, Daniel Tillett, Chief Executive Officer of Racura Oncology, said the first patient dosing marks an important step in the clinical development of RC220. He noted that the trial is driven by the need to address TKI resistance in EGFR-mutant NSCLC and explore a novel therapeutic strategy that could improve outcomes for patients receiving osimertinib. He also acknowledged the contributions of Associate Professor Surein Arulananda, the Monash Health clinical team, and the patients and families participating in the study.