• RC220 IND approved by Korean MFDS after extensive review
• Enables patient recruitment at 4 sites in South Korea
• Follows regulatory clearance in Australia and Hong Kong

Race Oncology Ltd (ASX: RAC) is pleased to announce that the Republic of Korea (Korea) Ministry of Food and Drug Safety (MFDS) has approved the Investigational New Drug (IND) application to evaluate the safety, tolerability and pharmacokinetics of RC220 in combination with doxorubicin in solid tumour patients. The MFDS IND approval follows a detailed review of the comprehensive RC220 data package, including nonclinical pharmacology and toxicology, chemistry, manufacturing and controls (CMC), and the clinical trial protocol. The requirements for MFDS IND approval are similar in rigour to the regulatory frameworks of the United States Food & Drug Administration (FDA) and the European Medicines Agency (EMA). The IND approval enables activation of three pre-selected clinical trial sites in Korea, with a fourth site expected to be activated following local Institutional Review Board (IRB) approval. This Korean regulatory approval follows previous regulatory clearance in Australia and Hong Kong. Race Oncology's CEO, Dr Daniel Tillett, commented that the IND approval from the Korean MFDS is an important milestone and allows patient enrolment in Korea, confirming the strength of the RC220 data package. The company looks forward to collaborating with its clinical partners in Korea to evaluate the potential of RC220 in combination with doxorubicin as a treatment option for adult patients with solid tumours.