IMMUNITYBIO, INC. EXPANDED ACCESS POLICY
About Expanded Access to Investigational Products
Enrolling in clinical trials is the primary way for patients to access investigational drugs and biologics (investigational products) sponsored by ImmunityBio, Inc. (ImmunityBio) and all subsidiaries of ImmunityBio. A complete listing of clinical trials by all sponsors, including ImmunityBio, can be found at clinicaltrials.gov. However, physicians treating patients who are facing serious or immediately life-threating diseases or conditions and do not qualify for ongoing clinical trials may request expanded access to investigational products from ImmunityBio via the following options:
- Single patient expanded access (compassionate use) – May be available to a single patient if the patient’s physician determines that there is no comparable or satisfactory alternative therapy to treat the disease or condition. In addition, the potential patient benefit should justify the potential risks of the treatment which should not be unreasonable in the context of the disease or condition to be treated.
- Expanded access program – May be available for patients who wish to continue, or new patients who meet program eligibility criteria for a disease or condition, in a clinical trial designed to be submitted in support of an application for marketing approval.
Procedure for initiating an expanded access request
Patients who are seeking access to ImmunityBio’s investigational products should speak with their physicians and discuss whether expanded access may be of benefit to them. If the treating physician feels that expanded access may be of benefit to the patient, the physician should contact ImmunityBio at SPIND@Immunitybio.com to make the request on behalf of their patient. Receipt of a request will be acknowledged within 3 business days.
Criteria to Evaluate Expanded Access Requests
ImmunityBio will consider expanded access requests from treating physicians in a fair, unbiased manner. Review of an expanded access request for an ImmunityBio investigational product for a serious disease or condition will be assessed using the following criteria:
- The patient or patients to be treated have a serious or immediately life-threatening disease or condition.
- The patient and a licensed physician are both willing to participate.
- The patient’s physician determines that there are no adequate alternative therapies or clinical trials available.
- There is sufficient preliminary efficacy and safety data available to support the use in the particular circumstance.
- There is sufficient evidence that the patient may expect a clinically meaningful benefit.
- Adequate supply exists to support both the ongoing clinical trials and approved compassionate use.
- The patient is not eligible or a candidate for an ImmunityBio-sponsored study. Geographic limitations to participation in a trial would typically mean a patient is not eligible.
- Expanded access will not adversely impact the clinical development program – in particular the initiation, conduct, or completion of clinical investigations to support marketing approval.
- The request is made by the patient’s treating physician, unsolicited by any other individual or organization.
- The patient does not have an underlying medical condition that poses an exceptional safety risk.
- The treating physician agrees to comply with local and federal regulations and guidances, as well as ImmunityBio conditions.
- Additional criteria regarding the patient, the investigational product, the clinical development program, or other factors may be evaluated as relevant.
Investigational products are not approved by the FDA. There is absolutely no guarantee of access to investigational products and ImmunityBio, Inc. reserves the right to change or update the policy at any time in our sole discretion.