Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 82

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 82
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 or withdrawal of future products marketed by us could materially affect our business in an adverse way. 

Changes in regulations, statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example: (i) changes to our sales and manufacturing arrangements; (ii) additions or modifications to product labeling or packaging; (iii) the recall or discontinuation of our products; or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business. 

European Union Drug Development 

In the EU, our future products also may be subject to extensive regulatory requirements. As in the United States, medicinal products can only be marketed if a Marketing Authorization (“MA”) from a competent regulatory authority has been obtained and additionally, the various phases of preclinical and clinical research in the EU are subject to significant regulatory controls. 

59

European Union Clinical Trials 

For example, in the EU, a clinical trial application (“CTA”) must be submitted for clinical trials in more than one EU Member State to the EU Clinical Trials Information System (“CTIS”) and an independent ethics committee, similar to the FDA and the IRB, respectively. The CTA must include, among other things, a copy of the trial protocol and an investigational medicinal product dossier containing information about the manufacture and quality of the medicinal product under investigation. Once the CTA is approved and the ethics committee has granted a positive opinion in relation to the conduct of the trial in the relevant Member State(s), clinical trial may commence. 

Clinical trials of medicinal products in the EU must be conducted in accordance with applicable laws and guidelines, including the International Conference on Harmonization (“ICH”) guidelines on GCP, as well as the ethical principles that have their origin in the Declaration of Helsinki. Additional GCP guidelines from the European Commission, focusing in particular on traceability, apply to clinical trials of advanced therapy medicinal products. If the sponsor of the clinical trial is not established within the EU, it must appoint an entity within the EU to act as its legal representative. The sponsor must take out a clinical trial insurance policy, and in most EU Member States, the sponsor is liable to provide ‘no fault’ compensation to any study subject injured in the clinical trial. 

The Clinical Trials Regulation ((EU) No 536/2014) establishes a centralised application procedure for clinical trials in the EU. Applications are submitted via CTIS. A clinical trial can only start in an EU Member State once it has been authorized (pot