ANKTIVA Mechanism and Applications - ANKTIVA activates NK cells and rescues T cells, serving as a foundational cytokine for universal cancer immunotherapy across multiple tumor types[18] - ANKTIVA, combined with BCG, is approved for bladder cancer and is being investigated in lung cancer, prostate cancer, colon cancer, and hematologic malignancies[20, 22] - ANKTIVA's mechanism overcomes tumor evasion by activating NK cells and rescuing T cells[12] Clinical Trial Results and Regulatory Status - In BCG-unresponsive NMIBC-CIS, ANKTIVA demonstrated a 71% complete response rate[25] - In BCG-unresponsive papillary NMIBC, ANKTIVA showed a disease-free rate of 55.4% at 12 months, 51.1% at 18 months, and 48.3% at 24 months, with 93% cystectomy avoidance[50] - In the NMIBC BCG-naive setting, ANKTIVA + BCG resulted in 100% complete response and disease-free status for at least 9.5 years in 6 out of 6 patients[54, 55] - An interim analysis of a Phase 3 trial in NMIBC BCG-naive patients showed an 84% complete response rate with ANKTIVA + BCG compared to 52% with BCG alone[57] - A BLA submission is planned for the QUILT-3.055 study (N=83) for lung cancer checkpoint progressors[70] Market Access and Launch - ANKTIVA received J-Code 9028 effective January 2025[35] - Market access covers 240 million medical lives as of November 2024[37] Intellectual Property - ImmunityBio has over 700 issued patents worldwide covering its immunotherapy portfolio[75]
ImmunityBio (IBRX) Earnings Call Presentation