RC220 Faces Next Regulatory Tests After Korean IND Nod
Race Oncology has secured Investigational New Drug approval from South Korea’s regulatory authority, enabling Phase 1 clinical trials of RC220 in combination with doxorubicin for solid tumour patients across four Korean sites.
- Korean MFDS grants IND approval for RC220 Phase 1 trial
- Approval follows rigorous review of chemistry, manufacturing, and clinical data
- Patient recruitment to begin at three sites with a fourth pending ethics approval
- Regulatory clearance complements prior approvals in Australia and Hong Kong
- RC220 trial focuses on safety and pharmacokinetics combined with doxorubicin
Regulatory Milestone in South Korea
Race Oncology Limited has achieved a significant regulatory milestone with the Republic of Korea Ministry of Food and Drug Safety (MFDS) granting Investigational New Drug (IND) approval for its Phase 1 clinical trial of RC220. This approval permits the company to initiate patient recruitment at multiple clinical sites in South Korea, marking a key step in the global development of its proprietary anticancer agent.
The MFDS’s endorsement came after an extensive evaluation of Race Oncology’s comprehensive data package, which included detailed chemistry, manufacturing, and controls (CMC) information, alongside nonclinical pharmacology and toxicology studies. The rigorous review process aligns closely with the standards set by other major regulators such as the US FDA and the European Medicines Agency, underscoring the robustness of the RC220 dossier.
Clinical Trial Activation and Site Readiness
With MFDS approval secured, Race Oncology is poised to activate three pre-selected Korean clinical trial sites, Samsung Medical Center, Asan Medical Center, and EWHA Woman’s University Medical Center. These sites have already obtained local ethics committee approvals, enabling immediate patient enrolment. A fourth site, Severance Hospital, is expected to join the trial following anticipated ethics clearance in the coming month.
The trial will assess the safety, tolerability, and pharmacokinetics of RC220 when combined with doxorubicin, a widely used chemotherapy agent, in patients with solid tumours. This combination aims to enhance anticancer efficacy while potentially offering cardioprotective benefits, addressing a critical need in oncology treatment regimens.
Global Regulatory Progress and Strategic Implications
This Korean regulatory success complements earlier IND approvals in Australia and Hong Kong, reflecting Race Oncology’s strategic push to establish a broad clinical footprint for RC220. CEO Dr Daniel Tillett highlighted the significance of the MFDS approval, noting the high standards of Korean healthcare and the historically strong patient recruitment rates in oncology trials within the region.
Race Oncology’s approach leverages collaborations with leading medical institutions and aims to accelerate access to RC220 for cancer patients worldwide. The company is also exploring partnerships and licensing opportunities to further its clinical development and commercialisation ambitions.
Looking Ahead
While the Korean IND approval is a critical step forward, Race Oncology remains mindful that regulatory pathways in other jurisdictions, including the US, may require additional dossier adjustments. Nonetheless, the current momentum positions RC220 well within the competitive oncology landscape as it advances through early clinical evaluation.
Bottom Line?
Korean IND approval propels RC220 closer to clinical reality, setting the stage for global trial expansion.
Questions in the middle?
- How quickly will patient enrolment progress across the Korean sites?
- What additional regulatory hurdles remain before US FDA approval can be sought?
- How might RC220’s combination with doxorubicin impact treatment outcomes in solid tumours?
