Race Oncology Ltd (ASX:RAC, OTC:RAONF) has received Investigational New Drug (IND) approval from the Republic of Korea’s Ministry of Food and Drug Safety (MFDS) to begin a Phase 1 clinical trial of RC220, its novel formulation of (E,E)-bisantrene.
The green light follows an extensive review of Race’s data package covering chemistry, manufacturing and controls (CMC), nonclinical toxicology and pharmacology, and the proposed clinical protocol.
The approval allows patient recruitment to start at three leading Korean hospitals — Samsung Medical Center, Asan Medical Center and EWHA Woman’s University Medical Center — all of which already hold ethics approval. A fourth site, Severance Hospital, is expected to come online following Institutional Review Board clearance in the coming weeks.
Trial to test RC220 in combination with doxorubicin
The Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of RC220 when given alongside the widely used chemotherapy agent doxorubicin in patients with solid tumours. The approval brings Korea into Race’s expanding clinical footprint, following earlier regulatory clearances in Australia and Hong Kong.
Importantly, MFDS requirements are regarded as equivalent in rigour to those of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), reflecting the robustness of the RC220 data package.
“IND approval from the Korean MFDS is the result of focused effort from the Race team, working closely with the Korean regulators to achieve this important milestone,” CEO and managing director Dr Daniel Tillett said.
“This approval allows patient enrolment in Korea and confirms the strength of the RC220 data package,” he added. “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.”
Tillett noted that Korea’s healthcare and regulatory systems are internationally respected, and patient recruitment into oncology trials in the country has historically been strong.
Building momentum across Asia
The milestone adds to recent progress in Race’s development program. Earlier this month, the company lodged new global patent applications covering its lead drug substance (E,E)-bisantrene, aimed at protecting its intellectual property across major markets.
Read more: Race Oncology submits patent applications for (E,E)-bisantrene
Race is advancing RC220 as both a cardioprotective and anticancer agent, with the potential to enhance doxorubicin’s effect while reducing heart toxicity — a long-standing challenge in chemotherapy. The company is also exploring the candidate’s role in acute myeloid leukaemia and other cancers.
With Korean recruitment about to begin, Race continues to position RC220 within a coordinated global clinical strategy, supported by collaborations with leading cancer centres and ongoing discussions around potential partnerships or licensing opportunities.