Racura Oncology Announces Positive Safety Review Committee Recommendation in ongoing CPACS Clinical Trial

Safety Review Committee (SRC) gives Racura Oncology a recommendation to continue the Cardioprotection and Anticancer Synergy (CPACS) study in advanced solid tumor patients

SYDNEY, May 15, 2026 /PRNewswire/ -- Racura Oncology, an Australian Phase 3 stage clinical biopharmaceutical company, today announced that the independent Safety Review Committee (SRC) has completed its review of safety data from Cohort 1 of the ongoing CPACS clinical trial, evaluating the safety and pharmacokinetics of RC220 alone and in combination with doxorubicin in advanced metastatic solid tumor patients.

Following its review, the SRC recommended that the study continue, noting no safety concerns in patients treated with 40mg/m² of RC220 as monotherapy, or 40mg/m² of RC220 in combination with 60mg/m² of doxorubicin, in the first patient cohort of this groundbreaking trial.

"The SRC's unanimous recommendation to proceed with the trial, along with the absence of any safety concerns, represents an important milestone for this clinical program," said Daniel Tillett, CEO of Racura Oncology. "These findings support the continued advancement of RC220 into the next cohorts of this study. We wish to thank the patients and their families for their courage and generosity shown by participating in the CPACS trial."

Based on this positive SRC recommendation, Racura plans to proceed to screening of new eligible patients for enrolment in Cohort 2 (80mg/m² RC220 dose level) using an updated trial protocol, which includes an initial lead-in safety monotherapy cycle of doxorubicin prior to the administration of RC220. This protocol update enables an assessment of the anthracycline-cardioprotective potential of RC220 using a blood-based molecular test.

The Company has received the SRC's formal written recommendation and has promptly notified the clinical trial sites to initiate enrolment in Cohort 2, as patients present and meet the eligibility criteria.

About Cardioprotection and Anticancer Synergy (CPACS) Trial

The CPACS Phase 1 solid tumor clinical trial is exploring the preclinical discovery that RC220 can provide protection from anthracycline cardiotoxicity while improving the anticancer activity of anthracyclines. Stage 1 of the trial is using ascending doses of RC220 to determine the safety, tolerability, pharmacokinetics, and maximum tolerated combined dose (MTCD) of RC220 in combination with doxorubicin in up to 33 patients using a Bayesian design. The effects on a range of clinical biomarkers, including a blood-based measure of the cardioprotective mechanism of action of RC220, are also being explored in the study.

After interim analysis of the data, the optimal dosage of RC220 in combination with doxorubicin will be assessed in an additional 20 patients in Stage 2 for further safety, tolerability, and preliminary cardioprotective and anticancer efficacy signals. This open-label trial is being conducted across multiple sites in Australia, Hong Kong, and South Korea.

About RC220 & (E,E)-bisantrene

RC220 is a proprietary formulation of (E,E)-bisantrene designed to overcome drug solubility issues that prevent safe peripheral intravenous infusion. (E,E)-bisantrene is a clinical validated small molecule anticancer agent that primarily functions via G4-DNA and RNA binding, leading to potent silencing of the important cancer growth regulator MYC.

About Racura Oncology

Racura Oncology (ASX: RAC) is a Phase 3 clinical-stage biopharmaceutical company with a mission to silence cancer. Our lead asset, (E,E)-bisantrene, is a small molecule anticancer agent that primarily functions via G4-DNA and RNA binding, leading to potent silencing of the important cancer growth regulator MYC.

Racura is advancing a proprietary formulation of (E,E)-bisantrene (RC220) to address the high unmet needs of patients across multiple oncology indications, with a Phase 3 clinical program in acute myeloid leukemia (AML), a Phase 1a/b program in mutant epidermal growth factor receptor non-small cell lung cancer (EGFRm NSCLC), and a Phase 1a/b program in combination with the anthracycline doxorubicin, where we aim to deliver both cardioprotection and enhanced anticancer activity for solid tumor patients.

Learn more at www.racuraoncology.com.

Forward-Looking Statements

Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this release include, without limitation, statements regarding expectations regarding clinical development and regulatory strategy and the Company's ability to deliver meaningful value to patients and shareholders. These statements relate to future events, future expectations, plans and prospects. Although Racura believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Racura has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including market and other conditions. Any forward-looking statements contained in this press release speak only as of its date. Racura undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except as required by law.

SOURCE Racura Oncology