Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 83

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 83
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entially with conditions) by the concerned EU Member States via CTIS. Separately, the sponsor must obtain a positive opinion from the relevant, independent Ethics Committee(s). 

Any substantial changes to the trial protocol or other information submitted with the CTA must be notified to or approved by the relevant competent authorities and, where required, the relevant Ethics Committees. Investigational medicines used in clinical trials must be manufactured in accordance with GMP for investigational medicinal product. Other EU and national regulatory requirements and guidelines may also apply. 

During the development of a medicinal product, the EMA and EU Member States’ competent authorities provide the opportunity for dialogue and guidance on the development program. At the EMA level, this is usually done in the form of scientific advice, which is given by the CHMP. A fee is incurred with each scientific advice procedure. Advice from the EMA is typically provided based on questions concerning, for example, quality (chemistry, manufacturing and controls testing), nonclinical testing and clinical trials, and pharmacovigilance plans and risk-management programs. Advice is not legally binding with regard to any future MAA of the product concerned. 

We received approval from the EMA to renew our status as a small and medium-sized enterprise (“SME”) in 2025. If we are successful in maintaining our current SME status with the EMA, we will have access to additional administrative, regulatory and financial support, including fee reductions for scientific advice and regulatory procedures. 

European Union Drug Review and Approval 

In the EU, medicinal products can only be placed on the market after obtaining a MA. To obtain regulatory approval of an investigational biological product in the EU, we must submit an MAA. 

The centralised procedure results in a single MA, issued by the European Commission (based on the opinion of the EMA), which is valid across the entire territory of the European Economic Area (the “EEA”). The centralised procedure is compulsory for medicinal products  that are: (1) derived from certain biotechnology processes, such as genetic engineering, (2) contain a new active substance indicated for the treatment of certain diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative diseases, autoimmune and other immune dysfunctions and viral diseases, (3) designated orphan medicines and/or (4) advanced-therapy medicines, such as gene therapy, somatic cell therapy or tissue-engineered medicines. The centralised procedure may, at the request of the applicant, also be used in certain other cases. The centralised procedure