BreakBio Corp.

BreakBio is starting its first clinical trial (IND approved) in its first indication with initial RCT data expected in late 2025. We use high tech personalized drug design then manufacture to treat all solid cancers. Our immunotherapy is designed and manufactured per patient to attack 30 unique targets per patient, identified by an advanced Machine Learning platform. Recent results have created excitement in the cancer vaccine space: for example Moderna’s BTD to prevent cancer recurrence with a personalized cancer vaccine. We are the first company to do mass spec on each patient’s cancer cells. BreakBio co-founder David Hawke, formerly head of The MD Anderson Mass Spectrometry Facility, pioneered this. This data on the existing tumor immunopeptidome is used for AI training. To get real accuracy, our AI platform is the same for all patients, but is trained again from scratch for each patient. Leading academic centers like MD Anderson are running the trial. We'll be seeking BTD and Accelerated Approval.