Highlights

  • Racura Oncology Shares rose 3.29% to AUD 2.51 on 31 March 2026, driven by trial enrolment milestone.
  • First patient recruited into HARNESS-1 Phase 1 trial for lung cancer treatment
  • Trial evaluates RC220 in combination with standard therapy Osimertinib
  • Study targets resistance in EGFR-mutant non-small cell lung cancer
  • Stock has surged 134.58% over the past year, reflecting sustained investor interest

Racura Oncology Ltd (ASX:RAC) shares gained 3.29% to AUD 2.51 on 31 March 2026, extending a favourable 12-month rally of 134.58%, as investors responded to a key clinical development update.

The share price movement follows the company’s announcement that the first patient has been enrolled in its HARNESS-1 Phase 1 clinical trial, marking an important step forward in the development of its oncology pipeline.

Racura Oncology is a clinical-stage biopharmaceutical company focused on developing therapies aimed at addressing significant unmet needs in cancer treatment, with its lead asset RC220 being evaluated across multiple indications.

First Patient Enrolled in HARNESS-1 Trial

The company confirmed that the first patient has been recruited into the HARNESS-1 trial, a Phase 1 study assessing the safety, tolerability, and pharmacokinetics of RC220 when used in combination with the established therapy osimertinib.

The trial is targeting patients with non-small cell lung cancer (NSCLC) who carry epidermal growth factor receptor mutations (EGFRm), a group that commonly develops resistance to current standard treatments over time.

The initial patient was enrolled by the clinical team at Monash Health in Victoria, representing the first step in what is expected to be a multi-centre study.

Management highlighted the enrolment as a significant milestone, reflecting progress in advancing the clinical development of RC220 in lung cancer.

Addressing Resistance in Lung Cancer Treatment

A key focus of the HARNESS-1 trial is to explore whether RC220 can help prevent or delay resistance to tyrosine kinase inhibitors such as osimertinib, which are widely used as standard-of-care treatments in EGFR-mutant NSCLC.

Resistance to these therapies remains a major clinical challenge, with most patients eventually experiencing disease progression. The trial aims to generate data on whether combining RC220 with existing treatments can improve patient outcomes in this setting.

The study will also provide insights into safety and dosing, which are critical in early-stage clinical development.

Trial Design and Structure

HARNESS-1 is designed as a multi-centre Phase 1a/b trial, incorporating advanced screening and dose optimisation methodologies.

The study begins with a screening phase using circulating tumour DNA (ctDNA) to identify eligible patients. This is followed by a dose escalation stage, where participants receive RC220 in combination with ongoing osimertinib therapy.

During this phase, between 12 and 40 patients are expected to be treated, with dosing administered via intravenous infusion on a 21-day cycle.

An accelerated trial design will initially be used to efficiently identify appropriate dose levels, after which a Bayesian-based approach will be applied to determine the maximum tolerated dose.

Once dosing parameters are established, the trial will progress to a Phase 1b expansion stage, where approximately 40 patients will be randomised across different dose levels.

Participants will be monitored for safety and pharmacokinetics, as well as a range of secondary endpoints including progression-free survival, overall survival, and changes in tumour-related biomarkers.

Expansion Plans and Next Steps

Racura indicated that additional clinical sites are expected to be activated in the coming months, supporting broader patient recruitment and trial progression.

As the study advances, accumulated data from early stages will inform subsequent phases, including dose expansion and further evaluation of clinical outcomes.

The company noted that identifying an optimal dose early in development is intended to improve the likelihood of success in later-stage trials and future studies

Broader Pipeline and Strategy

RC220, the therapy being evaluated in the HARNESS-1 trial, is a proprietary formulation of (E,E)-bisantrene, a small molecule anticancer agent.

The compound works by targeting key cancer growth regulators, with prior studies demonstrating therapeutic activity alongside an established safety profile.

Racura is advancing RC220 across multiple oncology indications, including acute myeloid leukaemia and solid tumours, alongside combination therapy approaches aimed at enhancing efficacy.

The company is also engaged in collaborations with various research institutions and continues to explore partnership opportunities to accelerate development and potential commercialisation.