Race Oncology has advanced its Phase 1 clinical trial for RC220, submitting ethics approvals and bolstering its cash reserves to $18.78 million following a $5.25 million R&D tax incentive.
- Phase 1 trial ethics submission for RC220 completed, first patient expected Q1 2025
- Cash reserves increased to $18.78 million after $5.25 million R&D tax incentive
- New board appointment: Dr Megan Baldwin joins as independent Non-Executive Director
- Two senior scientists, Dr Kirsten Curnow and Dr Sumit Sahni, added to R&D team
- Discovery of 39 unique FTO protein-binding molecules enhances drug development pipeline
Progress Towards Clinical Milestone
Race Oncology Limited (ASX: RAC) has reported significant strides in its clinical development program with the submission of the ethics and regulatory package for its Phase 1 trial of RC220, a reformulated version of the chemotherapeutic bisantrene. The submission to the Bellberry Human Research Ethics Committee (HREC) in early December 2024 marks a critical step toward initiating patient treatment, anticipated in the first quarter of calendar year 2025.
Following minor clarifications requested by the HREC, which were addressed promptly by mid-January 2025, Race Oncology is poised to activate trial sites, starting with the Southside Cancer Care Centre in Miranda, NSW. Parallel preparations for additional Australian and international sites in Hong Kong and South Korea are underway, with ambitions to expand to up to 10 trial locations.
Financial Strength and Strategic Appointments
Financially, Race Oncology has fortified its position with cash and cash equivalents reaching $18.78 million as of 31 December 2024. This increase was driven by a $5.25 million R&D Tax Incentive payment from the Australian Taxation Office and $870,000 raised through option conversions. The company’s quarterly expenditure remained focused on research and development and drug manufacturing, accounting for over two-thirds of spending.
Complementing its clinical and financial progress, Race Oncology has enhanced its leadership and scientific expertise. The board welcomed Dr Megan Baldwin as an independent Non-Executive Director from 1 January 2025. Dr Baldwin brings extensive biopharmaceutical experience, notably from her tenure as CEO and Chief Innovation Officer at Opthea Limited, where she led a drug candidate through to Phase 3 trials and Nasdaq listing. Additionally, the company appointed two senior scientists, Dr Kirsten Curnow and Dr Sumit Sahni, whose backgrounds in medical communications and preclinical cancer research respectively, are expected to strengthen Race’s R&D capabilities.
Expanding the Scientific Frontier
Race Oncology also announced the discovery of 39 unique FTO protein-binding molecules through collaboration with Monash University’s Fragment Platform. These compounds represent promising candidates for novel drugs targeting the m6A RNA epigenetic pathway, implicated in various cancers. This discovery not only broadens Race’s intellectual property portfolio but also aligns with its strategic focus on epigenetic mechanisms in oncology.
CEO Dr Daniel Tillett expressed optimism about the company’s trajectory, highlighting the quality of new appointments and the imminent clinical trial commencement. He emphasized the potential of bisantrene to deliver meaningful outcomes for cancer patients, particularly through its cardioprotective profile compared to conventional anthracyclines like doxorubicin.
Looking Ahead
As Race Oncology prepares for the first patient dosing in its Phase 1 trial, the company’s strengthened cash position and expanded scientific team provide a solid foundation for advancing its clinical and drug discovery programs. The coming months will be critical to monitor regulatory approvals, site activations, and early clinical data that could validate RC220’s therapeutic promise.
Bottom Line?
Race Oncology’s upcoming trial milestones and robust cash position set the stage for a pivotal year in its oncology pipeline.
Questions in the middle?
- Will Race Oncology secure ethics and governance approvals on schedule to begin patient recruitment in Q1 2025?
- How will the newly discovered FTO-binding molecules influence Race’s drug development strategy and partnerships?
- What impact will Dr Megan Baldwin’s leadership have on Race’s clinical and capital market initiatives?