ISA Therapeutics B.V.

ISA Therapeutics (ISA) is developing ISA101b in HPV16 positive malignancies. The goal of our current clinical trial program is to obtain clinical data on ISA101b that is required by the US Food and Drug Administration (FDA) and other regulatory authorities for review and approval of marketing authorization applications for this investigational agent. ISA believes that focusing on clinical trials is the most appropriate way to achieve this goal; therefore, ISA101b is currently not offered outside of clinical trials and, at this time, ISA does not have an Expanded Access Program. In the event that ISA decides to consider expanded access, ISA will update its policy at that time and will then evaluate and respond to each request that it receives on a case-by-case basis. For more information on our investigational therapies and ongoing clinical trials, please visit clinicaltrials.gov.