BreakBio

BreakBio Corp, at 333 SE 2nd Avenue, Miami, Florida, develops individualised peptide immunotherapies. For each patient it combines tumour DNA and RNA sequencing with mass-spectrometry immunopeptidomics and its BreakBioAI ranking software, which the company says ranks more than 40 mutated and non-mutated targets per tumour, including cancer-testis and embryonic antigens, and it describes a 45-day process from biopsy to treatment. The company was started by Roy de Souza, founder of the ad platform ZEDO, after his wife's diagnosis with metastatic colon cancer in 2017. The company states its IND was cleared by the FDA. Two phase 1/2 studies with Miami Cancer Institute, posted in August 2026 and not yet recruiting when read, combine BreakVax with chemotherapy and anti-PD-1 therapy: one in PD-L1-negative (CPS below 10), germline BRCA-negative, locally advanced or metastatic triple-negative breast cancer (NCT07762703) and one in glioblastoma (NCT07762716). Its first registered cancer trial, NCT07762703, was posted on ClinicalTrials.gov in August 2026.