IO Biotech

Single-Patient EA Policies/Criteria IO Biotech ApS (IO Biotech) is the developer of a novel investigational drug product, IO102-IO103 Immunotherapeutic Cancer Vaccine. The investigational drug product is being evaluated for the treatment of previously untreated, unresectable or metastatic melanoma regardless of BRAF mutation status in combination with an anti-PD-1 antibody. At the current stage of clinical development, IO Biotech has chosen not to offer Expanded Access (EA) and will not accept EA requests for the investigational drug product for the following reasons: • IO Biotech’s ability to conduct clinical trials is limited. Offering EA under any setting at this time will impact IO Biotech’s ability to execute its trials due to a limited supply of the investigational drug product. • IO Biotech does not have the personnel and other resources to offer EA on a fair and equitable basis. • The investigational drug product requires special handling, transportation and training on the method of administration. As IO Biotech is not currently accepting EA requests, the specified policy information on procedures and evaluation criteria is not provided at this time. The status of EA restriction will be re-evaluated at later development stages. IO Biotech ApS Expanded Access Policy, Rev: 23 December 2020