Company: IOBT
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0000950170-25-047744
Chunk: 55

Company: IO Biotech, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 55
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ologics are also subject to other federal, state and local statutes and regulations. Our product candidates are early-stage and have not been approved by the FDA for marketing in the United States. 

Our product candidates must be approved for therapeutic indications by the FDA through a BLA before they may be marketed in the United States. The process generally involves the following: 

•completion of extensive preclinical studies in accordance with applicable regulations, including studies conducted in accordance with GLP requirements; 

•submission to the FDA of an IND, which must become effective before clinical trials to be conducted in the U.S. may begin and must be updated annually or when significant changes are made; 

•approval by an IRB or independent ethics committee at each clinical trial site before each trial may be initiated; 

•performance of adequate and well-controlled clinical trials in accordance with GCP requirements and other clinical trial-related regulations to establish the safety and efficacy of the investigational biologic for each proposed indication; 

•preparation and submission to the FDA of a BLA, after completion of all pivotal trials; 

•payment of user fees for FDA review of the BLA; 

•potential review of the product application by an FDA advisory committee, where appropriate and if applicable; 

•a determination by the FDA within 60 days of its receipt of a BLA to file the application for review; 

•satisfactory completion of an FDA advisory committee review, if applicable; 

•satisfactory completion of one or more FDA pre-approval inspections of the manufacturing facility or facilities where the biologic will be produced to assess compliance with cGMP to assure that the facilities, methods, and controls are adequate to preserve the product’s identity and continued safety, purity, and potency; 

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•potential FDA audit of the preclinical and clinical trial sites that generated the data in support of the BLA; 

•FDA review and approval of the BLA, including consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the product in the United States; and 

•compliance with any post-approval commitments and / or requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy (“REMS”) or to conduct a post-approval study. 

Nonclinical and Clinical Trials 

Nonclinical Trials 

Before testing any biologic product in humans, the product candidate must undergo rigorous nonclinical testing in vitro and in vivo. Such nonclinical in vitro and in vivo animal studies assess safety and in some cases to establish