Racura Oncology Clears First Safety Hurdle and Doubles RC220 Dose in Cancer Trial

CPACS trial clears first cohort — RC220 dose escalation approved

Racura Oncology (ASX: RAC) has received clearance from its Safety Review Committee (SRC) to escalate the RC220 dose in the Phase 1 CPACS trial from 40mg/m2 to 80mg/m2, following a review of Cohort 1 patient data. The SRC identified no dose-limiting toxicities and no safety concerns across all three Cohort 1 patients during the designated safety observation period. Notably, all patients remain alive despite their advanced metastatic tumour status at the time of enrolment, a promising early signal as the trial moves into its next phase.

Dr Daniel Tillett, CEO and Managing Director

“I am extremely proud of the Racura team and our clinical collaborators for reaching this important milestone. The safety seen to date with RC220 in advanced cancer patients, including the absence of dose limiting toxicities even when combined with a standard of care doxorubicin dose, is highly encouraging. Finally, we wish to thank the patients and their families for their courage and generosity shown by participating in the CPACS trial.”

What the Safety Review Committee’s clearance actually means

A Safety Review Committee (SRC) is a panel of clinicians and trial experts responsible for independently overseeing patient safety during a clinical trial. In the context of a Phase 1 dose-escalation study, the SRC’s role is to assess whether it is safe to increase the dose administered to patients before the trial proceeds to the next cohort.

For the CPACS trial, the SRC reviewed a comprehensive body of data from all three Cohort 1 patients, including:

• Adverse events and laboratory findings
• Dose-limiting toxicities
• Pharmacokinetic data
• Other relevant patient observations

The committee’s determination that no safety concerns were present provides an objective, expert-led validation of RC220’s tolerability profile to date, including when RC220 was combined with doxorubicin at the standard of care dose of 60mg/m2.

While an independent SRC is not strictly mandated by regulation for Phase 1 dose-escalation studies, robust safety oversight is strongly encouraged by major regulatory bodies:

• USA FDA: 2026 Use of Data Monitoring Committees in Clinical Trials Guidance for Industry
• Australia NHMRC: Data Safety Monitoring Boards guidance
• European Medicines Agency (EMA): Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials

The SRC’s green light therefore carries meaningful weight for investors, signalling that RC220’s safety profile has withstood independent expert scrutiny at the first dose level.

Trial progression: what happens next in Cohort 2

With the SRC clearance confirmed, patient screening for Cohort 2 is now underway. New patients in Cohort 2 will be dosed at 80mg/m2 of RC220, a doubling of the Cohort 1 dose level, and will follow an updated trial protocol that introduces an important change to the treatment sequence.

Under the updated protocol, new Cohort 2 patients will receive an initial lead-in safety monotherapy cycle of doxorubicin before RC220 is administered. This modification is designed to assess RC220’s anthracycline cardioprotective potential using a blood-based molecular test, as detailed in Racura’s 11 February 2026 ASX announcement. The sequencing change allows clinicians to establish a baseline measure of doxorubicin’s cardiac effects before RC220 is introduced, enabling a cleaner assessment of any protective benefit RC220 may provide.

Cohort 1 patients who remain on active treatment will be transitioned to the updated protocol for all future treatment cycles.

Screening now open across three countries

Patient screening for Cohort 2 enrolment is currently underway across three geographies:

• Australia
• Hong Kong
• South Korea

This multi-centre, multi-geography enrolment approach broadens patient access and supports the pace of trial progression.

RC220’s broader clinical programme and investment thesis

The CPACS trial is one of three active clinical programmes that Racura is advancing with RC220, its proprietary formulation of (E,E)-bisantrene:

1. AML programme — Phase 3 clinical trial in acute myeloid leukaemia (AML)
2. EGFRm NSCLC programme — Phase 1a/b trial in mutant epidermal growth factor receptor non-small cell lung cancer
3. CPACS programme — Phase 1a/b trial in solid tumours in combination with doxorubicin

Within CPACS specifically, RC220 carries a dual therapeutic goal: delivering cardioprotection from anthracycline toxicity while also enhancing anticancer activity. This differentiated mechanism, if validated in later-phase data, positions RC220 as a potentially complementary agent to an established class of chemotherapy drugs rather than a standalone replacement.

Supporting the commercial case is Racura’s 20-year composition of matter IP protection over (E,E)-bisantrene, secured through recent patent filings. The company is actively exploring partnerships, licence agreements, or commercial merger and acquisition activity to accelerate RC220 access for patients globally.

RC220 active clinical programmes

With Cohort 2 screening now open and a clean safety record established at the first dose level, the Racura Oncology CPACS trial dose escalation marks a meaningful step forward in the company’s broader ambition to develop RC220 across multiple oncology settings.

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