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Personalized Cancer Immunotherapy
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Harnessing multi-omic profiling and proprietary AI to create truly individualized cancer treatments — designed for each patient's unique tumor.

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Our Science
Every Cancer Is Different
Every person's cancer has a unique molecular fingerprint. These two patients both have cancer, but their mutation profiles are completely different — which is what makes cancer so difficult to treat.
Patient 1
Patient 2
For representation only

How BreakBio Works

From biopsy to personalized treatment in 45 days, a truly scalable advanced manufacturing platform.

1

Patient Specific Multi-Omic Profiling

We analyze the individual patient's cancer cells using comprehensive DNA/RNA sequencing combined with advanced mass spectrometry.

2

BreakBioAI Targeting

Our proprietary BreakBioAI platform ranks 40+ mutated and non-mutated unique targets from each patient's tumor cells.

3

Personalized Manufacturing

Every patient receives a customized peptide immunotherapy to stimulate T-cells for their specific targets.

Phase 1/2 Clinical Trial Initiated

Beginning in 2026, BreakBio is currently enrolling patients for our first trial targeting Triple Negative Breast Cancer (TNBC).

FDA IND Approved
Investigational New Drug
Indication-Agnostic Platform
While our initial trial focuses on TNBC — one of the most difficult cancers to treat — our platform is indication-agnostic, designed to treat any solid cancer by targeting the unique mutations of each individual patient.
Synergistic with Standard of Care
Designed to work synergistically with standard-of-care treatments like checkpoint inhibitors, enhancing the body's existing immune response while adding highly personalized targeting.
Breakthrough Therapy Designation
BreakBio is pursuing FDA Breakthrough Therapy Designation, which accelerates the development and review of treatments intended for serious conditions where there is unmet medical need.

Our Team

Pioneers in cancer research, AI, proteomics, and personalized medicine.

Scientific Advisors & Board

Born From a Personal Fight

Roy de Souza had built a successful career in technology, founding ZEDO — one of the world's largest ad-serving platforms. But in 2017, when his wife Aisha de Sequeira was diagnosed with metastatic colon cancer, everything changed.

Rather than accept limited conventional options, Roy spent six months studying cancer research intensively. He partnered with leading scientists to develop a personalized cancer vaccine for Aisha — one that had to be manufactured and administered in Germany because U.S. regulations didn't yet allow it.

What I did for my wife, I want to make available to every cancer patient in the world.

That experience revealed how far behind cancer treatment was compared to what technology could enable — and it sparked the creation of BreakBio. Roy and Aisha were honored by the American Cancer Society in 2023 for their contributions to advancing personalized cancer treatment.

A documentary about their journey is being produced by USC professor Alex Rotaru.

More From Roy's Journey

Advancing Personalized Cancer Treatment

BreakBio is the third player in personalized drugs after Moderna and BioNTech and the top private company in the personalized drugs space with advanced cutting edge technology and clinical trials. BreakBio's treatment is designed for higher efficacy than Moderna or BioNTech and it is also designed to treat more cancer indications than Moderna or BioNTech.

01 — Higher Efficacy

More and Better Targets for Each Patient

BreakBio is designed for higher efficacy than Moderna's Individualized Neoantigen Therapy (INT). Higher efficacy because BreakBio is designed to find more and better targets per patient. It is an AI first biotech company. For every patient, its platform integrates the highest quality tumor DNA sequencing, RNA sequencing, mass-spectrometry-based immunopeptidomics (of that patient) with proprietary deep AI analysis to find better targets on that patient's cancer cells. Better targets means killing more (or all) of the cancer cells.

02 — More Cancer Indications

Beyond Neoantigens

BreakBio is designed to extend personalized drugs to more cancer indications. BreakBio achieves this by targeting not just neoantigens (associated with mutations as Moderna and BioNTech do) but it also searches for and finds, in each patient, some of the hundreds of cancer-associated non-mutated proteins such as cancer testis antigens, embryonic antigens, etc - so BreakBio is designed to also work for low mutational cancers, which means it is designed to work for all solid cancers both high mutational cancers like melanoma and low mutational cancers like colorectal.

Want to join our effort or get updates on our work?

Email
info@breakbio.com
Address
333 SE 2nd Avenue,
20th Floor Miami, FL
33131