Racura Oncology has secured governance approval to launch its Phase 1 HARNESS-1 trial, testing RC220 alongside osimertinib in EGFR-mutated non-small cell lung cancer patients. This milestone sets the stage for a potentially pivotal new approach to overcoming resistance in lung cancer treatment.
- Governance approval received from Monash Health for Phase 1 HARNESS-1 trial
- Trial targets EGFR-mutated non-small cell lung cancer patients on osimertinib
- RC220 aims to prevent or delay resistance to current standard therapies
- Multi-centre study includes ctDNA screening and adaptive dose escalation
- Additional clinical sites to be activated soon, with patient recruitment imminent
Governance Approval Unlocks Clinical Progress
Racura Oncology has reached a significant milestone with governance approval from Monash Health to commence its Phase 1 HARNESS-1 clinical trial. This trial will evaluate RC220 (E,E-bisantrene) in combination with AstraZeneca’s osimertinib, targeting patients with EGFR-mutated non-small cell lung cancer (NSCLC). The approval confirms that the necessary infrastructure and oversight are in place, allowing the company to move forward with patient recruitment and site activations.
Addressing a Critical Unmet Need
Osimertinib has become a cornerstone therapy for EGFR-mutated NSCLC, but resistance inevitably develops, limiting long-term effectiveness. Racura’s RC220 is designed to bind RNA and DNA G-quadruplex structures, potentially disrupting pathways that lead to this resistance. By combining RC220 with osimertinib, the trial aims to delay or prevent resistance, offering hope for improved patient outcomes in a disease area with significant unmet medical needs.
Innovative Trial Design and Execution
The HARNESS-1 trial is structured as a multi-centre Phase 1a/b study, beginning with circulating tumour DNA (ctDNA) screening to identify eligible patients. The dose escalation phase will enrol between 12 and 40 patients, using an accelerated trial design followed by a Bayesian Optimal Interval method to determine the maximum tolerated dose of RC220. This adaptive approach balances patient safety with the need to efficiently identify effective dosing.
Following dose escalation, a randomized, double-blind Phase 1b expansion will assess safety, pharmacokinetics, and preliminary efficacy signals such as progression-free and overall survival. The trial’s design reflects modern clinical development principles, including compliance with the FDA’s Project Optimus, which encourages optimal dosing strategies to maximise benefit and minimise toxicity.
Collaboration and Next Steps
Racura is collaborating closely with Monash Health and the contract research organisation Beyond Drug Development to initiate the trial at Monash Medical Centre in Clayton, Victoria. Site initiation and training are scheduled imminently, with additional clinical sites expected to come online in the coming months. This expansion will facilitate broader patient recruitment and accelerate data collection.
As a Phase 3 stage biopharmaceutical company, Racura’s pipeline includes multiple oncology indications, with RC220’s development in lung cancer complementing ongoing programs in acute myeloid leukaemia and solid tumours. The company is actively exploring partnerships and commercial opportunities to maximise the impact of its novel therapies.
Bottom Line?
With governance approval secured, Racura Oncology is poised to advance RC220’s clinical journey, potentially reshaping treatment for EGFR-mutated lung cancer.
Questions in the middle?
- How quickly will patient recruitment progress across multiple sites?
- What safety and efficacy signals will emerge from the dose escalation phase?
- Could RC220’s mechanism translate into broader applications beyond lung cancer?