ImmunityBio, Inc.

“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.”

NantKwest and ImmunityBio, Inc., a privately held immunotherapy company, reported on a compassionate use expanded access IND combining the PD-L1-targeted NK cell with ImmunityBio’s IL-15 fusion protein (N-803) in a patient with metastatic pancreatic cancer who had relapsed after prior standard of care therapy.

Conditions: NMIBC