FDA EIR - IMMUNOCORE, LLC - October 14, 2021

An FDA surveillance inspection of Immunocore LLC, located in Conshohocken, PA, was conducted from October 4 to October 14, 2021. This routine Prescription Drug User Fee (PDUFA) sponsor inspection, the company's first, aimed to assess Immunocore's oversight and responsibilities for clinical study IMCgp100-202, a Phase II study under NDA 114314. The inspection was performed in accordance with Compliance Program 7348.810 for Sponsors, Contract Research Organizations, and Monitors. A notable outcome of the inspection was that no Form FDA 483, Inspectional Observations, were issued, signifying compliance with regulatory standards. No refusals were encountered, and no samples were collected. The inspection comprehensively reviewed various aspects including organizational structures, standard operating procedures, vendor agreements, clinicaltrials.gov submissions, monitoring plans, and safety reporting mechanisms. While no formal violations were found, the report detailed an internal challenge at Site 6101 where a pharmacist initially resisted using a new drug formulation (IMCgp100, 0.2mg/ml) for several months. Immunocore’s clinical trial management team escalated and ultimately resolved this issue through direct intervention and training, leading to the formulation switch in March 2021. This demonstrates the sponsor's commitment to addressing operational issues. Immunocore exhibited robust oversight of its numerous outsourced services, including clinical investigator selection, site monitoring, data management, and pharmacovigilance, as evidenced by reviewed vendor management plans and regular communication protocols. Overall, the FDA inspection concluded without any regulatory findings, reflecting Immunocore's adherence to regulatory requirements for clinical trials.