ImmunityBio (IBRX) signed an exclusive development and supply agreement with Japan BCG Laboratory, or JBL, to get exclusive rights to develop, import, and commercialize the latter's intravesical Tokyo-172 BCG in the US, according to a Saturday statement.
Tokyo-172 BCG is backed by results of a phase 3 study in BCG-naive high-grade non-muscle invasive bladder cancer, which demonstrated Tokyo-172 BCG's non-inferiority to TICE BCG, ImmunityBio said. Tokyo-172 BCG is approved in Japan for this indication, the company added.
ImmunityBio plans to engage with the US Food and Drug Administration to pursue approval in the US, the company said. No financial terms were disclosed.