The study was designed explore the potential of Anktiva to enhance tumor-targeting of anti-CD20 therapeutic antibodies, and to determine the safety and efficacy of subcutaneous (SQ) versus intravenous (IV) administration. The combination regimen of Anktiva and Rituxan was well tolerated with a single reported grade 4 adverse event and no reported grade 5 AEs. For patients with anti-CD20 mAb sensitive disease, the ORR in the SQ cohort was 78% (7 of 9), 7 of 7 (100%) responses in the SQ cohorts were complete remissions.
Prolonged stable disease (SD) and conversion of SD and/or partial response (PR) to CRs with a prolonged duration without progression were observed, with 8 of 12 patients without progression at 18-24 months. For the 5 patients with anti-CD20 mAb refractory disease in both IV and SQ cohorts, the ORR was 2 of 5 (40%) with 1 CR, 1 PR, 1 SD, and 2 progressive disease (PD) with the PR and SD are ongoing at over 18 months.
In correlative immunology experiments, Anktiva in combination with Rituxan induced the expansion, activation and modulation of NK cells and CD8+ T cells, with minimal impact on CD4+ T cells and Tregs.
ImmunityBio gets FDA authorization for Phase 1 human study of NK cell platform with Anktiva
ImmunityBio has received FDA authorization to conduct a Phase 1 human study of its Memory Cytokine-Enriched NK cell platform combined with its IL-15 superagonist Anktiva in subjects with locally advanced or metastatic solid tumors. The clinical-stage immunotherapy company announced that its autologous and allogeneic cryopreserved memory NK cells have the ability to recognize and kill cancer targets with increased production of interferon-g, a cytokine demonstrating high activity.