FDA RMAT Designation for CAR-NK in Multiply Relapsed Locally Advanced or Metastatic Pancreatic Cancer

“RMAT designation for ANKTIVA combined with NK cells was applied for by the Founder in the initial 2017 IND. With the clinical results of the QUILT trials across multiple tumor types from 2017 to 2024, validating the hypothesis that high-dose chemotherapy and radiation induces lymphopenia and can be reversed by ANKTIVA together with off-the-shelf CAR-NK cells (PD-L1 t-haNK) resulting in prolongation of overall survival (OS), and enabling ImmunityBio to reapply for RMAT in 2025,”1 said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific & Medical Officer of ImmunityBio. “I am so grateful for the FDA to have recognized the evolution of science and the need for adoption of 21st century medicine and cell therapy, particularly the role of NK cell therapy in our war against cancer as a universal therapy in cancer, and in the potential treatment of infectious diseases such as HIV, HPV and COVID. Today’s designation of ANKTIVA and the first CAR-NK (PD-L1 T-haNK), both first-in-class molecules to activate lymphocytes within the body (via subcutaneous injection of ANKTIVA) and via ex-vivo infusion of off-the-shelf PD-L1 NK cells, is an inflection point and a paradigm change of how we could treat patients with cancer and viral infections. The absolute lymphocyte count (ALC) which has been largely ignored by physicians, since no therapy existed to address lymphopenia, could now be both a prognostic biomarker but more importantly, the potential as a therapeutic biomarker.”