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The FDA recently granted breakthrough therapy designation to a B7-H3-targeting CAR-T therapy for the treatment of diffuse intrinsic pontine glioma (DIPG). The CAR-T therapy is delivered directly into the brain via repeated intra-cerebroventricular doses. The FDA decision was based on encouraging data from the Phase 1 BrainChild-03 study conducted by Seattle Children’s, showing a median survival of 10.7 months from first CAR-T dose and 19.8 months from diagnosis among 21 DIPG patients, with three patients still alive at 44, 45, and 52 months post-diagnosis. There are now plans to launch a pivotal phase 2 trial later this year. We'll be having a webinar with Dr. Nicholas Vitanza about this therapy on May 29!