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.
The FDA has granted Fast Track designation to PLT012, a first-in-class anti-CD36 monoclonal antibody for hepatocellular carcinoma treatment. The Phase 1 trial is currently enrolling patients in Texas.
ImmunityBio has partnered with Accord Healthcare to expand access to Anktiva across 30 countries following conditional EU authorization. The company established an Irish subsidiary to support European distribution and commercialization.
Pluri Inc. receives patent grant from China National Intellectual Property Administration for its proprietary 3D immune cell expansion and activation technology, expanding global IP protection across U.S., China, Japan, Korea, Australia and Israel.