Expanded Access

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 a number of clinical programs and our lead oncology clinical stage candidate, HB-200 initially for the treatment of Human Papillomavirus 16-positive head and neck squamous cell carcinoma. HOOKIPA is currently conducting several clinical trials to demonstrate and establish safety, efficacy, and aiming at obtaining regulatory approval and access for patients in clinical practice.

Expanded access, also called compassionate use, is the option for use of an investigational therapy outside of a clinical trial to treat patients with a serious or immediately life-threatening disease or condition for which no comparable or satisfactory alternative therapies are available.

Expanded access may be appropriate when all the following apply:

Patient has a serious or immediately life-threatening disease or condition.

• There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
• Patient enrolment in a clinical trial is not possible.
• Potential patient benefit justifies the potential risks of treatment.
• Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

Investigational drugs and biologics, which have not yet been approved by any regulatory authority (such as FDA or EMA), do not have their safety, potential risks and benefits yet established. As such, an investigational drug may or may not be effective for the treatment of the condition in clinical development or for any other condition that may be in consideration, while the use of any such product may also cause new or unexpected severity side effects.

As HOOKIPA’s compounds in development are investigational drugs in the preclinical or early clinical development stages without established and confirmed clinical efficacy, safety and overall benefit-profile profile, the company does not currently offer Expanded Access to any of its experimental therapies in any indication at this stage. Participation in one of our clinical trials is the most appropriate way to access any of our investigational therapies. As we progress our clinical development programs, HOOKIPA will continue to assess the emerging clinical data for each individual program and re-evaluate periodically the evolving eligibility requirements for Expanded Access to its investigational drugs.

If you have questions about HOOKIPA Pharma’s expanded access policy, or would like more information about any of our ongoing or planned clinical trials, please contact us directly at office(at)hookipapharma.com.

To learn more about HOOKIPA Pharma’s ongoing clinical trials, please click here.