Racura Oncology Taps Beyond Drug Development for Pivotal Lung Cancer Trial
Racura Oncology has appointed Beyond Drug Development to oversee its HARNESS-1 Phase 1a/b trial combining RC220 with osimertinib in EGFR-mutated non-small cell lung cancer patients, marking a key step toward clinical advancement.
- Beyond Drug Development appointed as CRO for HARNESS-1 trial
- Phase 1a/b study to recruit up to 80 EGFR-mutated NSCLC patients across five Australian sites
- Trial to assess safety, dosage, pharmacokinetics, and preliminary efficacy of RC220 plus osimertinib
- Contract valued at approximately AUD 3.05 million with milestone-based payments
- First patient recruitment expected in Q1 2026, pending governance approvals
Racura Oncology Advances Clinical Development with CRO Appointment
Racura Oncology Limited has taken a significant stride in its clinical development program by appointing Beyond Drug Development as the contract research organisation (CRO) to support its HARNESS-1 Phase 1a/b trial. This study will evaluate RC220, Racura’s proprietary formulation of its lead anticancer agent, in combination with osimertinib for patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
The HARNESS-1 trial is designed to recruit up to 80 patients across five Australian clinical sites, aiming to generate critical data on safety, tolerability, pharmacokinetics, optimal dosing, and early signs of efficacy. The first patient enrolment is anticipated in the first quarter of 2026, subject to governance approvals, marking the transition of RC220 into human clinical testing in this indication.
Innovative Trial Design and Experienced CRO Partnership
Beyond Drug Development, an Australian-owned private company founded by seasoned CRO experts, was selected after a rigorous evaluation process. Their expertise aligns well with the innovative aspects of the HARNESS-1 trial, which incorporates advanced methodologies such as circulating tumour DNA (ctDNA) biomarkers, an accelerated single-patient cohort design, and Bayesian Optimised Interval Design (BOIN) for dose optimisation. These approaches aim to enhance trial efficiency and precision in dose finding.
The partnership is formalised under a Master Service Agreement valued at approximately AUD 3.05 million, with payments structured around milestone achievements. The final cost will depend on patient recruitment numbers and other operational variables, reflecting the adaptive nature of clinical trial execution.
Strategic Implications for Racura Oncology
Racura’s CEO, Daniel Tillett, highlighted the appointment as a pivotal milestone in advancing RC220 towards clinical application, underscoring the company’s commitment to improving treatment options for lung cancer patients. This trial represents a critical step in validating RC220’s potential to enhance the efficacy of osimertinib, a current standard of care for EGFR-mutated NSCLC.
Beyond the immediate clinical objectives, the trial’s success could bolster Racura’s positioning in the competitive oncology biopharmaceutical landscape and support future partnerships or licensing opportunities. The company’s broader pipeline, including Phase 3 programs in acute myeloid leukemia and other oncology indications, stands to benefit from the clinical insights gained through HARNESS-1.
As the trial progresses, stakeholders will be watching closely for recruitment milestones and early safety and efficacy data, which will inform subsequent development phases and commercial strategies.
Bottom Line?
Racura’s collaboration with Beyond Drug Development sets the stage for critical clinical insights that could redefine treatment for EGFR-mutated lung cancer.
Questions in the middle?
- How will the innovative trial design impact recruitment speed and data quality?
- What preliminary efficacy signals might emerge from combining RC220 with osimertinib?
- Could positive HARNESS-1 results accelerate partnerships or licensing deals for Racura?
