ImmunityBio’s Expanded Access Program

Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

ImmunityBio is focused on developing transformative medicines for people with serious and life-threatening diseases. To do this, we conduct clinical trials to assess the safety and effectiveness of investigational medicines, which, if established, will help us obtain approvals from regulatory authorities. These approvals, in turn, are required before medicines can be made widely available to patients.

Consistent with our mission, we encourage awareness of and participation in clinical trials. Clinical trials are controlled research studies in humans designed to determine if an investigational medicine is safe and effective. We believe that participating in clinical trials is the best way for patients to access investigational medicines prior to regulatory approval.

In some cases, when it is not possible for a patient to participate in a clinical trial, the patient is in critical medical need, and all other available medical options have been exhausted, the patient’s physician may seek special access to an ImmunityBio investigational medicine outside of the clinical trial setting. These situations are often referred to in various ways, including managed access, expanded access, early access, preapproval access, compassionate use, and emergency use.

Single Patient Investigational New Drug (SPIND) – 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.

Making decisions about requests for expanded access to investigational medicine is always complex. We endeavor to make these decisions in a fair and equitable manner, taking into consideration the patient’s case, the available medical and scientific information about the investigational medicine, and the probability and timing of a regulatory approval. Our top priority when evaluating requests for expanded access to investigational medicines is to ensure that we are not putting patients at risk of unnecessary harm.

To that end, ImmunityBio will consider an expanded access program, or a single request for expanded access of an investigational medicine, only if all of the following criteria are met:

• The patient’s licensed physician submits an unsolicited request for expanded access.
• The patient has a serious or life-threatening illness and fulfills objective clinical criteria establishing that the patient is in critical need.
• There are no comparable or satisfactory alternative therapies approved and available to treat the disease or condition.
• The patient is ineligible for, or otherwise unable to, participate in a clinical trial for the product.
• Expanded access is permitted under applicable law.
• The investigational medicine has been evaluated in pivotal clinical trials and, based on these pivotal clinical trials, there are sufficient and meaningful data to support a preliminary assessment that the potential benefits to the patient outweigh the potential risks.
• Staff and other required resources are available to provide the product, and there is a sufficient amount of product available.
• Providing the product will not jeopardize regulatory approval or clinical development of the product.
• ImmunityBio expects to file for regulatory approval for the investigational medicine and there is a path to sustainable access for all patients in the patient’s country of residence.

All requests will be carefully evaluated in a fair and equitable manner by ImmunityBio medical professionals with every effort made to provide a response promptly once we have all the necessary information. Decisions will be made based on the scientific evidence available to the company at the time of the request and applicable local laws and regulations.

Please note that enrollment of new patients in an expanded access program will continue for a maximum of 12 months after marketing authorization is obtained in the patient’s country of residence, unless local regulations require that the program terminates earlier.

We encourage patients to speak first with their physician about their eligibility to enroll in a clinical trial. If a treating physician believes that expanded access may be the only option for a patient, the physician should contact ImmunityBio to make a formal request on behalf of the patient. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals, if applicable, and to comply with all other safety, monitoring, and patient consent requirements defined by ImmunityBio. Requests for expanded access may only be made by licensed physicians through ImmunityBio’s Medical Affairs Department at SPIND@Immunitybio.com. ImmunityBio will seek to acknowledge receipt of requests within five business days.

Please contact ImmunityBio’s Medical Affairs Department if you have questions about or requests for expanded access to ImmunityBio medicines or investigational compounds.

For further information on available expanded access programs, visit www.clinicaltrials.gov and search “expanded access programs.” Detailed general information on expanded access programs can be found on the FDAs website at https://www.fda.gov/news-events/public-health-focus/expanded-access. A complete listing of clinical trials by all sponsors, including ImmunityBio, can also be found at clinicaltrials.gov.

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.