Race Oncology (ASX:RAC) has achieved another milestone in the global development of its lead asset, RC220, with regulatory approval granted by South Korea’s Ministry of Food and Drug Safety (MFDS) for a Phase 1 clinical trial in solid tumours.
The approval follows earlier clearances in Australia and Hong Kong, paving the way for patient recruitment at leading Korean hospitals.
The MFDS approval was granted following an extensive review of RC220’s data package, which included chemistry, manufacturing, and controls, as well as nonclinical pharmacology and toxicology, and a detailed clinical trial protocol.
The regulator’s requirements are considered comparable in rigour to those of the US Food and Drug Administration and the European Medicines Agency, underscoring the strength of Race’s submission.
Patient recruitment will begin at Samsung Medical Center, Asan Medical Center, and Ewha Woman’s University Medical Center, all of which have already received ethics approval. A fourth site, Severance Hospital, is expected to commence once local approval is finalised.
RC220 is Race’s proprietary formulation of bisantrene (RCDS1), being developed in combination with the chemotherapy agent doxorubicin. The Phase I study will evaluate its safety, tolerability, and pharmacokinetics, with the potential to deliver both enhanced anti-cancer activity and protection against doxorubicin-related cardiotoxicity.
Race Oncology’s Chief Executive Officer, Dr Daniel Tillett, welcomed the outcome, describing it as “the result of focused effort from the Race team, working closely with Korean regulators to achieve this important milestone.” He added: “This approval allows patient enrolment in Korea and confirms the strength of the RC220 data package. We look forward to collaborating with our clinical partners in Korea to evaluate the potential of RC220 in combination with doxorubicin as a treatment option for adult patients with solid tumours.”
South Korea has a reputation for high standards in healthcare and clinical research, with strong enrolment rates in oncology trials. Race believes this will accelerate trial progress and help position RC220 as a globally relevant therapy. The company is pursuing a development strategy that spans multiple regions, supported by collaborations with institutions including MD Anderson, Sheba City of Health, and leading Australian universities.
With approvals now in three jurisdictions, Race is advancing RC220 as a candidate that could redefine anthracycline-based cancer therapy by pairing anti-cancer efficacy with cardioprotection. The company is also exploring broader applications for RC220, including low-intensity treatment for acute myeloid leukaemia.