Race Oncology’s RC220 Trial Expansion Signals Growing Momentum Amid Cancer Drug Race

Race Oncology Expands Clinical Trial Footprint

Race Oncology Limited (ASX: RAC) has announced the activation of a second clinical trial site for its Phase 1 study of RC220, a reformulated version of its lead anticancer drug bisantrene. The new site at the Central Coast Local Health District, encompassing Gosford and Wyong Hospitals, follows the earlier activation of the Southside Cancer Centre in Miranda, NSW. This expansion is a strategic move to accelerate patient recruitment and enhance the collection of vital clinical data.

The Phase 1 trial is designed to evaluate the safety, tolerability, pharmacokinetics, and maximum tolerated dose of RC220 when combined with doxorubicin in patients with advanced solid tumours. Importantly, the study also aims to explore RC220’s potential cardioprotective properties and its effects on m6A RNA pathways, which are increasingly recognized as significant in cancer biology.

Innovative Trial Design and Global Reach

Utilizing a Bayesian trial design, Race Oncology’s study offers greater flexibility and speed compared to traditional clinical trials. The initial stage will enroll up to 33 patients to determine the optimal dosing regimen, followed by a second stage involving an additional 20 patients to further assess safety and preliminary efficacy signals. The trial spans multiple sites across Australia, Hong Kong, and South Korea, reflecting Race’s commitment to a broad and diverse patient population.

CEO Dr Daniel Tillett emphasized the importance of the second site activation, stating it will facilitate faster patient enrolment and data collection. He highlighted the collaborative efforts with clinical partners and reaffirmed the company’s dedication to advancing RC220’s clinical development.

Scientific Rationale and Market Potential

RC220 is a reformulated bisantrene, a small molecule anticancer agent with a well-characterized safety profile and demonstrated efficacy in both adult and paediatric cancers. Notably, bisantrene has shown less cardiotoxicity compared to anthracyclines like doxorubicin, which are standard treatments but carry significant cardiac risks.

Race’s preclinical data indicate that bisantrene enhances the cancer-killing activity of doxorubicin in a majority of tested cancer cell lines. Additionally, the drug’s inhibition of the FTO enzyme involved in m6A RNA regulation opens new avenues for targeting cancer at the epigenetic level. This dual mechanism positions RC220 as a promising candidate to improve outcomes in solid tumour oncology.

Next Steps and Investor Considerations

With patient enrolment underway at two Australian sites and ongoing preparations at international locations, Race Oncology is poised to deliver critical Phase 1 data in the coming months. Investors will be watching closely for interim safety and pharmacokinetic results, as well as any early signs of cardioprotection and anticancer efficacy.

Race is also actively exploring partnerships and licensing opportunities to accelerate global access to bisantrene, which could significantly enhance its commercial prospects if clinical results prove favorable.