ImmunityBio Announces Database Lock for Registrational Trial of Locally Delivered, Chemotherapy-Free ANKTIVA® Plus BCG in BCG-Naïve Non-Muscle Invasive Bladder Cancer

Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio

“QUILT-2.005 was designed to investigate whether, ANKTIVA, an IL-15 receptor agonist, could build upon the trained immunity induced by BCG by activating natural killer (NK) cells and CD8+ cytotoxic T cells with upregulating memory T cells to enhance therapeutic effectiveness earlier in the bladder cancer treatment journey,”

Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio

“With the database lock now complete in this randomized trial of 366 patients, we are entering a critical phase of validating the important role an IL-15 superagonist plays in the next evolution of immunotherapy. It has been established that chemotherapeutic approaches for the treatment of bladder cancer result in a reduction of NK and T cells, lymphocytes that are important for durable responses. The final analysis of this study will determine whether adding ANKTIVA to BCG improves complete response rates and the durability of those responses when compared with BCG alone, potentially resulting in the first intravesical, chemotherapy-free treatment approach for patients with BCG-naïve NMIBC. We look forward to sharing the findings once the analysis is complete.”

Richard Adcock, President and Chief Executive Officer of ImmunityBio

“Achieving database lock brings us another step closer to our planned sBLA submission and our goal of expanding chemotherapy-free treatment options for patients with NMIBC. This progress reflects the coordinated efforts of our clinical development team, investigators, and site personnel across 110 U.S. and global clinical sites. We are especially grateful to the patients whose participation has made this important research possible.”