ImmunityBio's ANKTIVA and CAR-NK Receive FDA RMAT Designation for Lymphopenia Reversal and Pancreatic Cancer Treatment

ImmunityBio, Inc. (NASDAQ: IBRX) announced today that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for ANKTIVA® (nogapendekin alfa inbakicept) and CAR-NK (PD-L1 t-haNK) for the reversal of lymphopenia in patients receiving standard-of-care chemotherapy/radiotherapy and in the treatment of multiply relapsed locally advanced or metastatic pancreatic cancer. This designation, which provides all Breakthrough Therapy Designation features and statutory ways to support Accelerated Approval, is a significant milestone for ImmunityBio and its quest to address unmet needs in cancer treatment.

The RMAT designation is based on clinical data from ImmunityBio's QUILT trials, which demonstrated significant correlations between Absolute Lymphocyte Count (ALC) and Overall Survival (OS) across multiple tumor types. ANKTIVA, an IL-15 receptor agonist, has shown the ability to proliferate and activate NK cells, CD4+ T cells, CD8+ T cells, and memory T cells without increasing suppressive T regulatory cells. This unique mechanism of action has the potential to improve overall survival in patients with pancreatic cancer and other solid tumors.



The reversal of lymphopenia by ANKTIVA and CAR-NK is a critical aspect of their potential to improve overall survival in patients with pancreatic cancer. Lymphopenia, a common side effect of chemotherapy and radiotherapy, is associated with reduced immune cell counts and impaired immune function. By reversing lymphopenia, ANKTIVA and CAR-NK can help restore the immune system's ability to recognize and attack cancer cells, leading to improved overall survival.



ImmunityBio plans to submit a Biologic License Application (BLA) for both indications and will provide data from fully enrolled clinical trials in metastatic pancreatic cancer (QUILT-88) and checkpoint relapsed NSCLC (QUILT-3.055). Additionally, ImmunityBio will file an Expanded Access Policy (EAP) for ANKTIVA and PD-L1 t-haNK in combination with standard care within 15 days.

The RMAT designation is a testament to the potential of ANKTIVA and CAR-NK in addressing unmet needs in cancer treatment, particularly in the reversal of lymphopenia and the treatment of multiply relapsed locally advanced or metastatic pancreatic cancer. With this designation, ImmunityBio is poised to make significant strides in its mission to provide innovative therapies for patients with limited treatment options.