HOOKIPA Pharma is committed to developing novel immunotherapies, leveraging our versatile arenaviral platform, that mobilize and amplify targeted T cells to address unmet needs in cancer. We are currently evaluating our lead oncology candidates, HB-201 and HB-202, for the treatment of Human Papillomavirus 16-positive head and neck cancer. Our current focus is to complete our ongoing clinical trials to demonstrate safety and efficacy in order to obtain regulatory approval and provide widespread availability of HB-201/HB-202.
We believe the most appropriate way to deliver on our commitment to patients is through participation in clinical trials. These clinical studies are needed to demonstrate that the medicine meets the standards for safety and efficacy that government regulatory agencies (e.g., the U.S. Food and Drug Administration and the European Medicines Agency) have established for granting approval. Gaining regulatory approval for a medicine is the best way to bring rapid access to the greatest number of patients who may benefit.
Expanded access, also called compassionate use, is the use of an investigational therapy to treat patients who are unable to participate in clinical trials and have serious or life-threatening diseases such as cancer. Currently, HOOKIPA does not offer an expanded access program, and does not accept expanded access requests. As we progress our clinical development program and learn more about our investigational therapies, we will review our policy on expanded access. Additionally, the posting of this policy by Hookipa does not serve as a guarantee of access to any specific investigational new drug by any individual patient.
If you have questions about HOOKIPA Pharma’s expanded access policy, please contact us directly at office(at)hookipabiotech.com.
To learn more about HOOKIPA Pharma’s ongoing clinical trials, please click here.