Race initiates its first Phase I trial location for a cardioprotective anticancer drug candidate.

Highlights

• Race Oncology commences Phase I trials of RC220 in New South Wales, marking progress in its oncology treatment strategy.

• The study evaluates RC220 both alone and combined with doxorubicin to assess safety and treatment compatibility.

• International expansion is underway, with future site activations planned in Hong Kong and South Korea by year-end.

Race Oncology (ASX:RAC), a clinical-stage biotechnology company focused on the development of oncology therapeutics, has initiated patient enrolment for its Phase I clinical trial of RC220. This trial is a key component of the company’s efforts to advance cancer therapies targeting advanced solid tumors. With governance approval and documentation finalized, enrolment began at Southside Cancer Centre in Miranda, New South Wales.

This milestone follows recent approval from the Bellberry Human Research Ethics Committee, enabling future trial site activation at Gosford and Wyong Hospitals. The approvals form part of Race Oncology's broader strategic framework aimed at accelerating its clinical development program within Australia and globally.

RC220 Clinical Study Design

RC220 is a modernized formulation of bisantrene, a compound initially developed several decades ago. This reformulated version is recognized for its lower impact on heart health compared to other anthracene-based cancer treatments. The ongoing study will assess RC220 for safety, tolerability, and pharmacokinetics both as a standalone therapeutic and when used in combination with the chemotherapeutic agent doxorubicin.

Race Oncology has designed the trial as an open-label study consisting of two stages. The first phase will focus on gathering safety data and determining dosage parameters. The second phase will extend these findings across various treatment combinations and patient populations.

The company’s current plans include expanding the trial to additional international sites, with Hong Kong and South Korea identified as future locations. Further ethical approvals for these regions are anticipated in the coming months, contributing to the company’s goal of activating multiple clinical sites by the close of the calendar year.

Multi-Regional Expansion Strategy

The trial is structured to eventually incorporate approximately nine trial sites worldwide. By integrating multiple healthcare institutions across different jurisdictions, Race Oncology aims to generate a diverse and comprehensive dataset to support the broader development of RC220.

This global trial infrastructure reflects the growing trend of cross-border clinical research in the oncology space, providing broader access to investigational therapies while enhancing the scientific robustness of clinical outcomes.

Dr. Daniel Tillett, CEO of Race Oncology, highlighted the swift progression through regulatory processes as a testament to the coordination between the company’s internal teams and external research collaborators. The current momentum has laid a strong foundation for continued clinical advancement.

Chief Medical Officer Dr. Michelle Rashford also noted that the successive site approvals have contributed to steady forward movement in trial implementation. These efforts underscore the company’s long-term focus on therapeutic innovation within the oncology sector.

Positioning in the Healthcare Segment

Race Oncology continues to enhance its standing within the biotech and oncology domain by focusing on reformulated therapeutics with favorable safety profiles. Its lead candidate, RC220, exemplifies this approach by leveraging historic compounds through modern reformulation techniques to address contemporary treatment challenges.

By driving clinical trials across multiple countries and engaging with ethical oversight bodies efficiently, Race Oncology is strategically aligning itself with evolving standards in global cancer care. The company’s development roadmap for RC220 positions it within the active biotechnology cohort on the ASX 200, with increased relevance among healthcare stocks demonstrating clinical advancement in solid tumor therapies.