ImmunityBio said the Saudi FDA encouraged submission of a regulatory package for recombinant BCG and opened talks on expanding ANKTIVA with checkpoint inhibitors to additional tumor types. The company expects to file the rBCG package within weeks.
Interim results from the ABC phase 1/2b trial show a calcineurin inhibitor-free GVHD prevention regimen combining posttransplant cyclophosphamide, bortezomib, and abatacept achieved low GVHD rates and favorable survival outcomes. The approach enables earlier introduction of posttransplant maintenance therapies while reducing toxicity associated with conventional immunosuppressants.
CAR T-cell therapy market advances with AI-driven manufacturing improvements and over 250 companies developing 500+ drug candidates, including breakthrough solid tumor treatments and GPC3-targeted therapies for hepatocellular carcinoma.
ImmunityBio completed enrollment of 366 patients in its Phase 2 trial of ANKTIVA plus BCG versus BCG alone for BCG-naïve bladder cancer. Interim analysis showed statistically significant improvement in duration of complete response, with the company anticipating a BLA submission by Q4 2026.
Researchers at Washington University in St. Louis have adapted CAR-T immunotherapy to target aggregated amyloid-beta in mice, with transient CAR expression clearing brain plaques. The approach uses CD4+ T cells engineered with receptors based on lecanemab antibody sequences.
ImmunityBio received European Commission authorization for ANKTIVA in bladder cancer, expanding to 33 countries. The company held productive discussions with Saudi regulators on recombinant BCG and checkpoint inhibitor combinations.
A phase 1 clinical trial demonstrates that mRNA-1283, a next-generation COVID-19 vaccine encoding receptor-binding and N-terminal domains of the spike protein, induces durable T cell immunity at a 10 µg dose comparable to the standard 100 µg mRNA-1273 vaccine.
