Phase 1b/2 BreakVax personalized vaccine + PD-1/CTLA-4 checkpoint blockade in GBM

This Phase 1b/2, multicenter, open-label, single-arm study in adults with glioblastoma (GBM) tests a multi-component immunotherapy strategy anchored by BreakVax (BB-101), a per-patient designed/manufactured personalized cancer vaccine from BreakBio Corp intended to prime tumor-antigen–specific T cells. BreakVax is given with Montanide and poly-ICLC (innate immune adjuvants; poly-ICLC is a TLR3/MDA5 agonist) plus low-dose subcutaneous ipilimumab (Bristol Myers Squibb; CTLA-4–blocking monoclonal antibody used here locally as a dendritic-cell/T-cell priming adjuvant) and pembrolizumab (Merck; PD-1–blocking monoclonal antibody to reduce T-cell exhaustion). The regimen also includes temozolomide (generic; DNA-alkylating chemotherapy), losartan (generic; angiotensin II type 1 receptor blocker), and aspirin (generic; COX inhibitor) to potentially promote immunogenic cell death and favorably remodel the tumor microenvironment. The design includes a safety lead-in to characterize DLTs followed by an expansion cohort assessing preliminary activity (including 12-month overall survival) in GBM patients without prior PD-1/PD-L1 exposure. For this population, today’s care is maximal safe resection when feasible, radiation plus temozolomide, and then limited effective options at recurrence (often clinical trials; sometimes bevacizumab for symptom control), so the commercial/scientific angle is whether an individualized vaccine can meaningfully sensitize a typically “cold” tumor to checkpoint blockade.