Former FDA Head Steve Hahn Joins BreakBio, a Personalized Cancer Drug Company, as Advisor

MIAMI, Oct. 26, 2026 /PRNewswire/ -- BreakBio, a biotech company developing personalized drugs for cancer, today announced that Stephen M. Hahn, M.D., former Commissioner of the U.S. Food and Drug Administration (FDA), has joined the company as an advisor.

Dr. Hahn led the FDA as its 24th Commissioner, overseeing reviews of COVID-19 therapeutics and the Emergency Use Authorizations for the Moderna and Pfizer-BioNTech vaccines. Previously, he chaired Radiation Oncology at the University of Pennsylvania, then served at MD Anderson as Division Head and Chair of Radiation Oncology, Deputy President and Chief Operating Officer, and Chief Medical Executive. He later joined Flagship Pioneering as Chief Medical Officer of its Preemptive Medicine initiative, became a Flagship CEO-Partner and CEO of Harbinger Health, and is now CEO of Nucleus RadioPharma.  

"Steve has had a front-row seat to fundamentally new therapeutic platforms," said Roy de Souza, BreakBio CEO and Co-Founder. "That combination of experience is extraordinarily valuable as BreakBio works to advance its best-in-class personalized drugs."

"Recent clinical trial results mark an important inflection point: personalized drugs have now demonstrated that they can deliver meaningful efficacy while also being practical to manufacture for individual patients," said Dr. Hahn. "I believe we are entering a new era of medicine in which therapies designed for each patient become an important new class of pharmaceuticals—and BreakBio has the potential to play a significant role in that transformation."

BreakBio is developing personalized peptide-based immunotherapies designed using the unique molecular characteristics of each patient's tumor. Unlike approaches focused primarily on mutation-derived neoantigens, BreakBio targets both mutated and non-mutated cancer-associated proteins, potentially expanding personalized immunotherapy to a broader range of solid tumors and patients.

Dr. Hahn will advise BreakBio on clinical development, regulatory strategy, oncology, platform development and corporate strategy.

About BreakBio

BreakBio is a private company in a new category of pharmaceuticals: personalized drugs for cancer and other non-transmissible diseases that are different in each patient. Moderna, with its Individualized Neoantigen Therapy (INT), demonstrated the potential of its personalized cancer immunotherapy in August 2026 and has probably established personalized drugs as a novel pharma category. BreakBio is not the first-in-class but aiming to be the best-in-class personalized drugs, designed to both achieve high efficacy and also to treat a broad range of cancer indications.

BreakBio's proprietary AI/ML platform uses mass spectrometry of the immunopeptidome for every single patient as a key ground-truth data input, as well as DNA and RNA analysis. This extensive data per patient allows the AI to find better targets per patient and therefore aims to generate the highest possible efficacy. 

Unlike personalized cancer drugs focused primarily on mutation-derived neoantigens, BreakBio targets both mutated and non-mutated cancer-associated proteins identified by its AI/ML platform for each patient's cancer. BreakBio is therefore designed to treat not just high-mutational cancers like melanoma, but also low-mutational cancers, and therefore designed to treat far more solid tumors.

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www.BreakBio.com

SOURCE BreakBio Corp.