• Beyond Drug Development appointed to support HARNESS-1 Phase 1a/b trial of RC220 in combination with osimertinib
• Trial to recruit NSCLC patients with active EGFR mutation across 5 sites in Australia
• Study will provide safety, tolerability, pharmacokinetic, dosage, and preliminary efficacy data

Racura Oncology Ltd has appointed the Contract Research Organisation (CRO) Beyond Drug Development ('Beyond') to support the HARNESS-1 Phase 1a/b clinical trial of RC220 in combination with osimertinib in patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). Beyond was selected after an extensive evaluation of Australian CROs and has been integral in obtaining ethics approval for the trial, along with managing other start-up activities. The HARNESS-1 trial will recruit NSCLC patients with active EGFR mutation across five sites in Australia. The study will provide human safety, tolerability, pharmacokinetic, optimal dosage, and preliminary efficacy data, with the first patient expected to be recruited in Q1 CY2026. Beyond is an Australian-owned private company founded by CRO industry experts with an average of 20 years' experience and a focus on providing tailored, adaptable services to the biotechnology sector. The capabilities and flexible approach provided by Beyond support the innovative approaches being used in the HARNESS-1 trial, including the use of a circulating tumour DNA (ctDNA) biomarker, an initial accelerated trial design (single-patient cohorts), and a Bayesian Optimised Interval Design (BOIN) for RC220 dose optimisation. Racura has engaged Beyond under a Master Service Agreement (MSA) with an estimated total contract cost of $3.05m over the course of the study, with payments made after completion of key milestones and the final total dependent on the number of recruited patients and other cost variables.